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1014(;314 TE201513565
13565 Masch,nenbuch
1

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Machine Book for: Container Blender

Machine number: 13565


Year of construction: 2016

Manufacturer: Customer:

Servolift GmbH Eurofarma Laboratories SA


Albert-Einstein-Strasse 9 Rodovia Castello Branco, Km 35,6
77656 Offenburg Itapevi - Sao Paulo
Germany Brazil

Phone: +49 (0) 781-6100-0


Fax: +49 (0) 781-6100-400
E-mail: info@servolift.de
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Table of contents
.,
1. Masterdata 3
1.1. General information 3
2. Description of Product 4
3. Technical Data 5
3.1. General data 5
3.2. Fixings 5
3.3. Material and surface 5
3.4. Blending drive 6
3.5. Horizontal clamping system consisting of: 6
3.6. Lifting device 6
a.7. Electricity 6
3.8. Control 6
3.9. Control cabinet 6
3.10. Safety 7
3.11. Interface 7
3.12. Safety installations and Components 8
3.13. Securing of the hydraulics against excess pressures 8
3.14. Factory adjustment with nominal load 8
3.15. Securing of the pneumatics against excess pressures 8
3.16. Attachment to Machine Book 9
3.17. Changes in design and major repair work 9
4. Test certificates 10
4.1. Factory Acceptance Test 10
4.2. Acceptance test at the user 11
4.3. Repeat test on site 12
S. Carrying out regular tests by competent persons of Servolift
5.1. 13
(
5.2. Supporting structure and wearing parts 13
5.3. Hydraulics 13
5.4. Electrics 14
5.5. Safety equipment and technical documents 14
Test report 14

Test at the User's -Attachment-


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1. Master data

1.1. General information

Manufacturer: SERVOLIFT GmbH


Albert-Einstein-Str. 9
77656 Offenburg-Zunsweier
Germany

Machine number: 13565

Description: Container Blender

Year of construction: 2016

Delivery date:

Initial operation

Load capacity 1000 kg (incl. bin, pallet)

EX-protection category -/-

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2. Description of Product

2.1. Intended Use of the Machine

The blender is exclusively destined to take the descript containers with a maximum load of 1000 kg
and to blend them.
Operation is done on a separate operating terminal as touch display.
The controls are located at a separate stainless steel control cabinet
The danger zone is protected by customer with safe potential free contacts on process site door
switch.
The machine is not designed for any other use than that listed above.
For all for injury to persons and damage to property which occur from inappropriate use, the liability
is only subject to the user off the machine and not to the manufacturer.

(
2.2. Overview of the System

The machine is stationary and bolted to the floor.


Lifting is powered by a hydraulic cylinder located into the machine
A carriage inside the column is moved up and down along a guideway.
The machine is mounted on a plate
The blend drive with the pick-up arm are fixed to the carriage inside the column.
The pick-up arm supports the load.
Clamping is motorised.
The functions are operated on a separate operator panel.
Blending is only possible if the danger zone is protected.

(
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3. Technical Data

3.1. General data

pick up for container 1600L. according to drawing 41585-70-001


pick up for container 700L. according to drawing 40902-70-001
pick up for container 400L. according to drawing 40903-70-001
pick up for container 200L. according to drawing 40696-70-001
pick up for container 100L. according to drawing 40695-70-001
load capacity 1000 kg (container + product)
blending volume approx. 20-80%, of rated volume depending on product
product granulate / powder, free flowing
- suitable for blending in a gravity blender
blending rotary speed, adjustable 5 - 15 rpm
blending time, adjustable 1 ... 99 min
reverse/change direction of rotation 0 ... 99 minutes, (0 minutes no change)
levelling 0 ... 5000 millisecond (ms), 1000 ms. no levelling)
min. lift height 910 mm (=pick up height containers 100L, 200L, 400L, 700L)
pick up height container 1600L: 1030 mm
max. lifting height 1450 mm
total length 3077 mm
machine width 2190 mm
overhang (center column - outlet) 1471 mm
sound pressure level <78d8(A)

3.2. Fixings

design free standing (floor mounted)


floor fixation
- compound anchor on-site available concrete floor
compound anchor bolt HAS-TZ M16x125/100 Hilti
compound anchor capsule HVU-TZ M16
dynamic set M16
min. required: concrete thickness 250 mm
minimum characteristic of concrete: 825, C20/25
floor even and horizontal, maximum slope: 0,5%
!Floor has to be strong enough to absorb the forces of the machine!

3,3. Material and surface

stainless steel design


exterior parts
- 1.4301 (AISI 304)
- 1.4306 (AISI 304)
- 1.4541 (AISI 321)
mechanical treated parts (bearing flange, grips, height stops)
- 1 .4104 (AISI 430F)
- 1.4057 (AISI 431)
- Aluminium
interior parts
- S235JR
- S355JO
- S355MC
surfaces pharmaceutical design:
- surface of mounting parts, mechanical stainless steel parts grinded, Ra s 1,5 urn
- flat welding seams, grinded planer to sheet metal, fillet welding seams grinded
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3.4. Blending drive


worm gear motor with brake
- pinion (permanent lubricated)
- external geared large pivot bearing

3.5. Horizontal clamping system consisting of:


- closed tube profile connected to the blending bearing
- sensors for the right container position.
- rotating transmission for all supply and control cables
- pick up flange with 30 stagger to the blending axis
- positioning and guide rails
clamping system
- hydraulic clamping system with swivelling cylinder

3.6. Lifting device


lifter
( - internal guiding system
- simple-acting hydraulic cylinder with pilot operated check valve as a safety device
- splash water protection bars
cover band
- polyester with urethane coating
- sealed edges
- FDA-conform

3.7. Electricity
energy supply 380V, 60Hz, 3Ph, PE
power consumption 13 kW
electric supply to be installed on site to the control cabinet by customer
connecting cable between the top of the control cabinet and the separate operator panel:
- cable 20 m length, cabling and installation are not in our supply.
control voltage 24 VDC
class of electrical components IP 54
Ex-protection
- no ATEX requirements
electric installation ace. EN 60204, with single core labelling
{
3.8. Control
Control PLC-control Siemens S7-300 into control cabinet
Main switch on the door of the control cabinet
Separate operator panel outside of the blending room with:
- operator terminal Touch 12" colour
- laser printer for DIN A 4 paper sheets
- HMI for: lifting / lowering and clamping / unclamping
- pushbutton for emergency stop
- pushbutton "Agreement for rotation function"

3.9. Control cabinet


unibody cabinet with separated electric and hydraulic compartments:
- upper part with the electric control elements
- underneath part with the hydraulic power unit, the valves for the hydraulic functions.
location of control cabinet:
- in the same room as the machine
- max. distance 5 m
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3.10. Safety

lifting device
- lifting range mechanically limited
- with relockable check valve for safety reason
clamping
- safety valve fixed on the cylinder to protect against loss of pressure
- in case of damage, the clamping device remains closed
overload protection
for all the load related functions, no movement possible
overload protection for lifting movement
adjustable pressure control valve, no movement possible
safety device
monitoring of clamping pressure

3.11. Interface

Customer supplies and installs


- the safety switch with solenoid interlock acc. to active current principle (for example from
company Schmersall AZM300)
- the cable from the safety switch to the control cabinet of the blender.
- Customer informs Servolift if any additional doors have to be protected.
Signal output from blender control system to the customer danger zone safety protection:
- one potential free contact "blending in process" (=1 contact closed while rotating)
Signal input from customer danger zone safety protection to the blender control system.
- three potential free door contacts "door closed" (contact closed if door is closed)
- two potential free door contacts "door locked" (contact closed if door is locked)
blending only possible, if safety device is active

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3.12. Safety installations and Components

Pilot operated check valve installed into lift cylinder.

Pressure limiting valve for lifting movement factory adjusted and sealed.

Operator panel installed outside the blending room.

Monitoring of clamping pressure by a pressure switch.

Lifting range mechanically limited

3.13. Securing of the hydraulics against excess pressures


(
Permissible maximum operating pressure for hydraulic system 150 bar

Hydraulic circuit Operating pressure Response pressure


Pressure limiting valve
(set pressure rates)

CLAMP ~O bar ~s5 bar

LIFT 15" bar Jed bar

TILT -/- bar -/- bar

SLEW -/- bar -/- bar

3.14. Factory adjustment with nominal load

( Adjusted Lift Speed :3 4 cmls

Adjusted Lower Speed 3, ~ cmls

Set Time to Invert -I- s

Set Time to Slew -/ - s/deg

Maximum Blend Speed 2 "-


1 rqm

3.15. Securing of the pneumatics against excess pressures

Permissible maximum operating pressure for pneumatic system: -/- bar


Minimum operating pressure required for pneumatic system: -I - bar

Setting for pressure limiting valve of the maintenance unit: -I - bar

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---------- 87-14
3.16. Attachment to Machine Book

the operating instructions with the documents listed below must be assigned to the machine book

General arrangement drawing containing the main dimensions


Electrical scheme with parts list
Hydraulic scheme with parts list
Description of the style and function
Operating and maintenance instructions

3.17. Changes in design and major repair work

Date: Description

The design engineer responsible decides whether a new machine book needs to be prepared.
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4. Test certificates
4.1. Factory Acceptance Test

'Test carried out by the expert at Servolift premises before initial operation

"Machine number 13565

The SERVOLIFT unit has successfully stand Factory Acceptance Test on 4--1, 0v7.. 2 (;? --7 t

After site erection, check of anchoring and connection to energy by an expert no concerns are seen to put
the unit into operation.

test before initial operation at user's site can be recorded on the following page.
(

"

Expert:

Name and address of the expert: SE:ntOLiFT


Qualitatssicherung

Place' Date Signature

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4.2. Acceptance test at the user


,-
Result of the test carried out by the expert before initial operation
-'

Machine number 13565

The test includes in particular:

- Check of place of erection to suitability


Check of dowel setting report
Check of screw fixings
Check of safety circuits
Check installation and function of safety elements
Check of load suspension using original loads from the user
Working area of the operator

(
The Servo lift unit was subjected to a test for readiness for service on

Faults were found: yes 0 no o


If yes - the following faults were found:

Part tests still to be carried out:

Dowel report about correct setting of anchors is existing and filled out.
yes 0 no o
( The machine is marked by CE- label and Declaration of Conformity is available and signed.
yes 0 no [gI

There are reservations about putting the unit into operation: yes 0 no o
Repeat test is necessary yes 0 no o
Expert:

Name and address of the expert:

Place / Date Signature

5aieT:-f3565_Machine-Book~docx .-_.--.---- --.------ --------Verslon:-;------- ----- .. -. -------.----_.'--"-'--""--'- .- . -"'---------rn 14


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4.3. Repeat test on site

Result of the test carried out by the specialist before initial operation

Machine number 13565

the Servolift unit was subjected to a test for readiness for service on

Faults were found: yes 0 no o


If yes - the following faults were found:

Part tests still to be carried out:

There are reservations about putting the unit into operation: yes 0 no o
Repeat test is necessary yes 0 no o

Expert:

Name and address of the expert:

Place / Date Signature


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5. Carrying out regular tests by competent persons of Servolift

instructions for carrying out tests within the context of regular or exceptional tests

the performances include the following tasks:

5.1. Supporting structure and wearing parts

Visual inspection of all supporting parts for corrosion and deformations, this applies particular
for weld seams.
Check of all chains, in particular the chain locks and connecting links.
Check of lubrication of all bearing parts. (Some of the ball bearings are lifetime lubricated)
Check of all ball and slide bearings.
Check of attachment elements, in particular anchors, screws with safety functions etc.

( Functional test
with 90 ... 100 % of the perm issible load
Function and wear of the cover bands
Check of the rotary and tilt drives (motors, gear rims, stops etc.)
Check of the load suspension device
Tightness and condition of gears
Function
State

5.2. Hydraulics

Check of all hydraulic cylinders:


a) Tightness
b) Piston rod damage
c) De-aeration of the hydraulic system

Checking the hydraulic system (power pack, valves, fittings, pipes, brake):
a) Tightness and function
b) Check of pressure limiting and safety valves e.g. check valves with release,
line rupture valves and settings of pressure limiting valves

Check of hydraulic hoses:


a) Damage
b) Tightness of the fittings
c) Replacement of the hoses every 6 years

Check and maintenance of power pack:


a) Evaluation of state of hydraulic oil
b) Check of oil level

Latest every 6 years:


a) Opening and cleaning of tank
b) Replacement of filter
c) Replacement of hoses

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5.3. Electrics

Check of the electric system:


a) Check of safety circuits
b) Cable fixing and installation
c) Check of the electrical cables for damages
d) Fixing of cords
e) Setting values for the motor circuit breaker
f) Functional check

5.4. Safety equipment and technical documents

Check of the safety-related functions and signal equipment of the electric, hydraulic and pneumatic
circuits and/or switching elements (sensors).

Check of the signs and warning marks.


( Check of owner's manual for completeness
Delivery of the required drawing documents and/or supplementing these when changes are
made.
Check of the control elements:
a) Function
b) Condition
c) Marking

5.5. Test report

Drawing up of the test result according to the enclosed forms.


Applying the test mark and/or notifying the operator of faults, or even shutting down the unit in the case of
significant safety problems.

14/14
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Test at the user's


.. ~
Test result for a: regular test D
exceptional test D
repeat test D
Machine number 13565 Inventory no.:

The Servolift unit was subjected to a test for readiness for service on

Faults were found: yes D no D

If yes - the following faults were found:

Part tests still to be carried out:

There are reservations about putting the unit into operation/ continuing to use it: yes D no D
Repeat test is necessary: yes D no D
Next inspection according to test badge:

,
Expert:
Name and address of the competent person:

Place! Date Signature

the test was carried out on behalf of the company:

Faults acknowledged: *)

Place! Date Signature

Faults eliminated on: ------*)

Place! Date Signature


*) Confirmation by the operator or his representative
I 11111111
10146299 - TE201513565
FAT Protckolt Kunde
1
SE=iVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: 107. Jan. 2016 I Version:

Factory Acceptance Test


for
Container Blender 13565

Eurofarma Laboraterlos S.A.,


Itapevi - Sao Paulo
Brazil

Servolift Name I Signature Position Date

Inspector
Sig: I Y..

Customer Name I Signature Position Date

{ Approved by:
Sig:

Approved by:
Sig:

Approved by:
Sig:

~ile: 13565 _FAT _1.docx


SE=iVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container I Project No. 13565

I
Blender
Date of Version: 107. Jan. 2016 I
Version: Table of Contents
1.1. Document History - Change Control 3

2. Identification 4
2.1. General Data 4
2.2. Reference Documents 4

Check of Order 5
3.1. Check of unit against the offered and ordered positions 5

4. Installation 6

5. Labelling 6
5.1. Labelling added to machine 6

6. Interlocks 7
6.1. in general: 7
6.2. for manual functions: 8
<,

6.3. for blend functions: 9


6.4. for maintenance functions: 9

7. Operation 10
'7.1. Control ON - general test 10
1.2. Password Management - general test. 11
7.3. LOGIN procedure, in example for OPERATOR level 11
1.4. LOGOUT procedure (manually actuated), for example for OPERATOR level. 12
1.5. LOGIN procedure, in example for ADMINISTRATOR level 13
7.6. LOGOUT procedure (automatic, if set time elapsed), for example for SUPERVISOR level 14
7 .7. Operating Terminal - general test offunctions at HMI 16
-
7.8. Check MANUAL MODE functions (positioning for blending) 18
7.9. Check BLEND PARAMETER functions 19
7.10. Check BLEND MENU functions 22
7.11. Check MANUAL MODE functions, moving back to start position 23
7.12. Check MAINTENANCE MENU functions 24

8. Documentation Check 25

9. List of Deviations I Repair work 27

10. Final Statement 28

File: 13565 _FAT _ 1.docx


SE=iVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container I Project No. 13565

I
Blender
Date of Version: 107. Jan. 2016 I Version: 1

1.1. Document History - Change Control

The following list registers the execution of changes for this document.

Version Date Editor Reason for Change

( 1 07.Jan.2016 BR/GM Initial Version

Remarks

Servolift / Sign Customer / Signature

File: 13565 _FAT _ 1.docx


SE=iVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container I Project No. 13565

IBlender
Date of Version: I 07. Jan. 2016 I Version: 1

2. Identification

2.1. General Data

Manufacturer Servolift GmbH

Type of machine Container Blender

Machine Number 13565

Project No. 1034322

Order No. 4500233630

Order Confirmation No. 1131069

2.2. Reference Documents

Document Version (current indices)

Function Specification I Function Design


13565_tb1
Specification (FS I FDS)

General Arrangement Drawing 13565-00-001

Hydraulic scheme 13565-61-001

Electric scheme 13565_EP_1_E

Remarks

I, r,
Servolift I Sig Customer I Signature

File: 13565_FAT_1.docx 4/28


SE=1VOLiFT
I Factory Acceptance Test (FAT)

Type of Machine: Container Blender Project No.

I Date of Version: 107. Jan. 2016 I Version: 1


3. Check of Order
3.1. Check of unit against the offered and ordered positions
,

Pos: Description Yes No

3.1.1. Container Blender 1000 kg, freestanding '.,L

3.1.2.
Operating Terminal i<
Receipe Management )(
3.1.3.

Printer installed into stainless steel box


3.1.4. X

3.1.5.
Potential free contact 'I-
Qualification documentation for blender (IQ, OQ, FAT, FS/FDS)
3.1.6. '1<

3.1.7.
SERVOLIFT Standard Documentation y

3.1.8. Translation of manual into Portuguese language >(

(
Other non-listed items as service work, packaging and transport are
not relevant for qualification, and thus not included in this table.

INFORMATION

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1y. .

File: 13565_FAT_1.docx
1.1/,
Servolift I Customer I Signature

File: 13565_FAT_1.docx
SE=lVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: 107. Jan. 2016 I Version: 1

4. Installation

Pos: Description Yes No

4.1. Check of state and dimensions acc. general arrangement 13565-00-001


X'

5. Labelling
5.1. Labelling added to machine

Pos: Description Yes No

5.1.1. Identification plate X'

5.1.2. 1000 kg load capacity X

5.1.3. Symbol

Operating elements correctly labelled


X

5.1.4. )<

5.1.5. Electrical test according EN 60204 X

Remarks

, L1 4, .>
1.1/, if
Servolift / Stbnature Customer / Signature
SE=iVOLiFT
I Factory Acceptance Test (FAT)

J Type of Machine: I Container Blender I Project No. 13565

j Date of Version: 107. Jan. 2016 I Version: 1

6. Interlocks
6.1. in general:

YES NO
confirm,
the control at HMI-terminal of Blender 13565 is only possible:
- if general power supply at electric cabinet is switched ON
6.1.1. - if HMI-terminal is initialized and y
- user is logged in to one of available 4 user groups
( (ADMINISTRATOR, SUPERVISOR, MAINTENANCE OR OPERATOR)
confirm,

6.1.2.
after initializing of HMI-terminal the operating language PORTUGUESE is
loaded, means it is indicated by national flag on first screen,
y
and it can be changed by tapping the symbol with national flag, e.c. to ENGLISH
confirm,
after an interrupt of running sequence, e.g. by a disturbance (E-Stop, blend
6.1.3. room access, etc.) the displayed fault message(s} has to be remedied, ~
confirmed and reset in separate menu ALARMS
confirm,
any interruption in movement can only be started again, if the cause for the
6.1.4. interruption is remedied, the fault message is reset, and the safety circuit is >(
activated by function key ACTIVATE SAFETY CIRCUIT

Remarks

I. 1/.
Servolift I Customer I Signature
SE=iVOLiFT
I Factory Acceptance Test (FAT)
'" . '7/28
SE=lVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: 107. Jan. 2016 I Version: 1


6.2. for manual functions:

YES NO
confirm,
- with activated operating language ENGLISH,
- logged in user "OPERATOR" and starting from MAIN MENU:
- if pressed key OPERATOR MENU and then MANUAL MODE
6.2.1. - the menu is opened and manual functions become visible in dark grey, -c
but cannot be started at this moment,
there are: LIFT I LOWER, CLAMP I UNCLAMP and TURN LEFT I RIGHT

confirm,
only after having pressed key ACTIVATE SAFETY CIRCUIT the manual ')(
function can be operated, these will be shown light grey, means function
6.2.2.
released

confirm,
LIFT I LOWER function (with inserted container in arm) is possible,

6.2.3.
- if supporting arm is in 0 turn position (= upright)
- if supporting arm is unclamped (means swivel clamps unclamped and y
centering cylinders retracted)

confirm,
CLAMP function is possible,
6.2.4.
- with container in position y
- supporting arm in max. height (= blend height)
confirm,
UNCLAMP function (with inserted container in arm) is possible,
6.2.5.
- if supporting arm is in 0 turn position (= upright) y
- if supporting arm is in max. height (= blend height)
confirm,
TURN LEFT I RIGHT function (with inserted container in arm) is possible,
- if supporting arm is in 0 turn position (= upright)
)<
6.2.6. - and in max. height (= blend height)
- and container is clamped
- blend room access - here safety door is closed

Remarks

Servolift I Customer I Signature

File: 13565_FAT_1.docx
SE~VOLiFT
'I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565


'I Date of Version: 107. Jan. 2016 1 Version: 1
6.3. for blend functions:

YES NO
confirm,
start blend cycle in BLEND MENU is only possible,
if following conditions are fulfilled:
- if supporting arm is in 0 turn position (= upright)
6.3.1. -
-
and in max. height (= blend height)
and inserted container is clamped
><
- blend room access - here safety door is closed
- and blend parameter are entered or selected

6.4. for maintenance functions:

YES NO
:

confirm,
the activation of MAINTENANCE MODE is possible on HMI-terminal,
- if user is logged in as member of MAINTENANCE level
- or logged in for a higher group level, e.g. as ADMINISTRATOR,
6.4.1.
- if MAINTENANCE MODE is opened (submenu in MAINTENANCE MENU), ~

in opened menu it will be possible to start each displayed function of the blender
without regarding current position or other interlocks, that's why user has to be
careful when starting any movement and consider the given warnings on HMI

Remarks

Customer / Signature

File: 13565_FAT_1.docx '9128


SE=lVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: 107. Jan. 2016 I Version:


7. Operation
7.1. Control ON - general test

YES NO
confirm,
by turning main switch located at electric cabinet to ON position 'X
7.1.1.
the control to operate the machine is ON

7.1.2.
confirm,
with general control on the initialization of HMI-terminal starts :
confirm,
the operating language PORTUGUESE is loaded, .--/
7.1.3.
it can be changed by tapping the symbol with national flag, e.g. to ENGLISH
confirm,
7.1.4. with operating language changed the MAIN MENU is displayed .:X
confirm,
at this moment no user is logged in or indicated at the head line

7.1.5. t 'f
y
~~R HAlH MfNU
c .. I
confirm,
only communication status between PLC and HMI
X
7.1.6.
is shown by green blinking symbol: IO~IIIIl!. I
confirm,
installed version of PLC and HMI can be read at MAIN MENU screen:
(
7.1.7. HMI YEn.IOl X
1 PLCVEII., 01 :1

Remarks

Servoli Customer I Signature


SE=lVOLiFT
File: 13565_FAT_1.docx
- -10128
SE=iVOLiFT
I Factory Acceptance Test (FAT)
I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: I 07. Jan. 2016 I Version: 1

1.2. Password Management - general test


Following approved user levels are pre-defined at delivery of machine:

Group enter into entry field: User . enter into entry field: Password
ADMINISTRATOR ADMIN1 ADMIN1
SUPERVISOR SUPERVISOR SUPERVISOR
MAINTENANCE MAINTENANCE MAINTENANCE
OPERATOR OPERATOR OPERATOR
(
the following test shows how to log in for a user group and which functionality is assigned. Here it will
only be tested to login for user group OPERATOR, the procedure to login as for the 3 other user groups /
levels will then be the same.

'1.3. LOGIN procedure, in example for OPERATOR level

YES NO
confirm,
('
7.3.1. with pressed key LOGIN. ~ X
the user Logon dialogue and the screen keyboard are displayed
confirm,
in opened dialog the cursor is blinking in input field "User" and expects ";x
7.3.2.
input
confirm,
after entering the user name "OPERATOR"
7.3.3.
and Confirmation with ENTER the user name is it is shown
?<
confirm, )<
7.3.4. with touch to input field "Password" the cursor is blinking and expects input
confirm,
after entering user password "OPERATOR"
7.3.5. and Confirmation with ENTER it is shown as " " , X
confirm, the password is not readable at the screen, it is hidden
confirm,
7.3.6. with pressed key OK the disQlayed Logon dialog is closed )<.
confirm,
user's name "OPERATOR" is indicated at the head line,

7.3.7.
means log in procedure was successful
and 'I
now user can start all assigned functions, e.g. in MANUAL MODE menu
test is continued on next page

Remarks

Customer / Signature

File: 13565_FAT_1.docx 11/28


SE=lVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: 107. Jan. 2016 I Version: 1

YES NO

confirm,
7.3.8.
if pressed key OPERATOR MENU,
the menu is opened and several submenus become visible
><
confirm,
7.3.9.
if pressed key MANUAL MODE,
the corresponding menu is opened, showing available manual functions
X
confirm,
if pressed key ACTIVATE SAFETY CIRCUIT here in the menu (key either
dark grey or light grey, doesn't matter) y
7.3.10.
an advice message, blue framed is given, showing that safety circuit is
activated and user is assigned here to start any function
confirm,
if pressed key EXIT (door symbol) the current menu is closed, OPERATOR X
7.3.11. MENU is displayed again and can also be closed by pressing key EXIT,
then the MAIN MENU is displayed again
confirm, y.
7.3.12. if pressed key EXIT again, the MAIN MENU is indicated again

7.4. LOGOUT procedure (manually actuated), for example for OPERATOR level

YES NO

confirm,

7.4.1. with pressed key LOGOUT 1 the current indicated user "OPERATOR" 'X
is logged out manually and at this moment no user is logged in
( confirm,

7.4.2.
when input of valid user identification (as described in "Login procedure")
is repeated user's name "OPERATOR" is indicated again at head line and v:
sequences can be continued by selecting needed menus and function

Remarks

I, r.
Servolift / Customer / Signature

File: 13565_FAT_1.docx 12 i 28
SE=iVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: 107. Jan. 2016 I Version: 1

7.5. LOGIN procedure, in example for ADMINISTRATOR level

YES NO
(. ;

7.5.1.
confirm, with pressed key LOGIN. J
the user Logon dialog and the screen keyboard are displayed
><
confirm,
7.5.2. with touch to input field "User" the cursor is blinking and eX_Q_ecitnsput X
confirm,
after entering the user name "ADMIN1"
7.5.3. and confirmation with ENTER the user name is it is shown
X
(
confirm,
7.5.4. with touch to input field "Password" the cursor is blinking and expects input 'X
confirm,
after entering user password "ADMIN1"
7.5.5. and confirmation with ENTER it is shown as "***" , -
confirm, the password is not readable at the screen, it is hidden
confirm,
7.5.6. with pressed key OK the displayed Logon dialog is closed X
confirm,
7.5.7. now user's name "ADMIN1" is indicated at the head line
-

Remarks

Customer / Signature

File: 13565_FAT_1.docx
SE=lVOLiFT
I Factory Acceptance Test (FAT)

Type of Machine: Container Blender Project No.

I Date of Version: 107. Jan. 2016 I Version: 1

7.6. LOGOUT procedure (automatic, if set time elapsed), for example for SUPERVISOR level

YES NO
confirm,
7.6.1. user is still logged in as ADMIN1, the name is indicated at the head line y
confirm,
7.6.2. with pressed key ADMIN. MENU the menu is oQ_ened X

(, l
confirm,
7.6.3.
X
with pressed key" the menu USER MANAGEMENT is opened
confirm,
here the overview of pre-defined user and user groups is given,

if searched user SUPERVISOR and click in 4th column "Logoff time"


'X
7.6.4. the displayed value of "5" (minutes) can be changed
by indicated numeric keypad,

=> change value to "1" (minute) and confirm by ENTER


confirm,
.')(
changed value of user SUPERVISOR in 4th column "Logoff time" is shown,
7.6.5.
it is set to 1 (minute)
confirm,
with pressed key EXIT (door symbol) displayed menu is closed, 'X
7.6.6.
ADMINISTRATOR MENU is shown again
confirm,
7.6.7. with pressed key EXIT again the MAIN MENU is displayed 'X
test continued on next page

Remarks

I. t>,
Servolift / Si Customer / Signature

File: 13565_FAT_1.docx 14/2


8
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: 107. Jan. 2016 I Version:


YES NO
,
confirm,
(. J
when press key LOGIN.
7.6.8. 'X
and enter valid user identification (as described in "Login procedure") again
for user SUPERVISOR the user's name is indicated again at head line
confirm,
if user "SUPERVISOR" is logged in
and no function key is pressed during a long time period at the HMI
(
7.6.9. the user is logged out automatically, X
here after the pre-configured time of t=1 minute, then no user is logged in,
no user name is indicated at head line and no movement can be started
confirm,
if input of valid user identification (as described in "Login procedure") )c(
7.6.10.
is successful again, the corresponding user name is shown in head line

confirm,
if doing following steps in described order
the modified logoff time is reset back to 5 minutes of user "SUPERVISOR":
therefore do following steps:
1. press key LOGIN
2. login as ADMIN1
3. call ADMIN. MENU ')(
7.6.11.
4. call USER MANAGEMENT menu.
.' ~
5. search user SUPERVISOR in overview list
6. and move to 4th column with value 1 minute for automatic logoff time
7. touch value, and change to 5 minute
( 8. confirm change by ENTER
9. close menu by EXIT key, ADMINISTRATOR MENU is displayed
10. press key EXIT again and return to MAIN MENU

Remarks

I. 1/. ./r~
Servolift ~ignature
A >:
Customer / Signature

File: 13565_FAT_1.docx 1~;'/28


SE=1VOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: 107. Jan. 2016 I Version: 1

7.7. Operating Terminal- general test offunctions at HMI

YES NO

confirm,
7.7.1. control is ON and HMI-terminal is initialized, MAIN MENU is indicated '>(
confirm,
7.7.2.
operating language ENGLISH is selected and active,
indicated by national flag at MAIN MENU
-
confirm,
7.7.3. user is logged in as "OPERATOR", user's name is shown at head line y:
( confirm,
with pressed key OPERATOR MENU and then key MANUAL MODE
7.7.4.
the menu is opened and available manual functions become visible
'?<
confirm,
with pressed emergency stop push button beside HMI-terminal
a message bar "ALARM" is indicated -.,<.
7.7.5.
and no function can be executed until pressed E-Stop is unlocked,
if unlock the pressed E-Stop the test can be continued with next step
confirm,
7.7.6. pressed e-stop is unlocked and message bar ALARM was pressed X
test continued on next page

Remarks

I. V.
Servolift / Customer / Signature

File: 13565_FAT_1.docx
- "16/28
SE=lVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I of Version: 107. Jan. 2016 I Version:


Date
YES NO

confirm,
in separate menu "ALARMS" the fault message(s) is(are) displayed with
date and time stamp in clear text, the fault message
7.7.7. V
can be confirmed by key ~; (Acknowledge) and key (Ai!it:! i
(Reset), confirm,
7.7.8. if pressed key EXIT current menu "ALARMS" is closed, menu MANUAL y
( MODE is shown again and key ACTIVATE SAFETY CIRCUIT is blinking
confirm,
7.7.9.
if pressed key ACTIVATE SAFETY CIRCUIT the safety module is on,
and manual functions (enabled functions are light grey) are released
.X-
confirm,
in case of communication error between PLC and HMI-terminal
7.7.10. by disconnecting the connection line (MPI-cable) no movement is possible, 'X
even if function keys at menu MANUAL MODE are pressed
confirm,
if connection line (removed MPI plug) between PLC and HMI )<'
7.7.11.
is re-connected again the test can be continued with next step
confirm,
in separate menu "ALARMS" the fault message(s) is(are) displayed with
date and time stamp In clear t~xt. the fault message 1 K
7.7.12.
can be confirmed by key

confirm, I
JJ . and key; .
' Af.'&T
(Reset),

(Acknowledge)

7.7.13.
if pressed key EXIT (door symbol) X
current menu "ALARMS" is closed, menu MANUAL MODE is shown again
('

Remarks

_,-
/. Y.
/ y / l

File: 13565_FAT_1.docx 17/28


SE=lVOLiFT
I Factory Acceptance Test (FAT)

---
Servolift / Sigrfature Customer / Signature

File: 13565_FAT_1.docx 17/28


SE=iVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: 107. Jan. 2016 I Version: 1

7.S. Check MANUAL MODE functions (positioning for blending)

YES NO

confirm,
Container Blender 13565 is in defined start position: means,
- arm is in min. height and clamps are open
- in 0 turn position (= upright) )<
7.8.1.
- with no container inserted in arm
- and safety door closed
- all openinQs (e.q. vent, lid) at the container must be closed
confirm,
(
7.8.2.
if safety door is opened, 'j
the container can be inserted into the arm by help of a hand pallet truck
confirm,
if container is in position, pallet truck can be removed
7.8.3.
and y
if leaving blending area and closing door from outside
the user is back at HMI to continue the sequence
confirm,
7.8.4. user is still logged in as "OPERATOR", name is displayed in head line .X"
confirm,
starting in MAIN MENU, if pressed key OPERATOR MENU
7.8.5. ~
the menu is opened and further submenus become visible
confirm,
7.8.6.
with pressed key MANUAL MODE
the menu is opened and available manual functions will be displayed Y
confirm,
if pressed key ACTIVATE SAFETY CIRCUIT, safety module is switched on, X
7.8.7.
all possible manual functions are released and displayed light grey
confirm,
( with pressed and hold key LIFT,
7.8.8.
lifting starts, it stops if pick up height big container is reached ><
confirm,
7.8.9.
with pressed and hold key LIFT again,
liftinQ starts, it stops if max. height is reached
><
confirm,
with pressed and hold key CLAMP,
7.8.10. X
clamping starts, it stops when container is clamped
confirm,
with pressed key EXIT (door symbol) the menu MANUAL MODE is closed,
y!'
7.8.11. OPERATOR MENU is displayed again and
PARAMETER MENU or TEST RECIPE menu are selectable

Remarks

Servolift I Customer I Signature

File: 13565_FAT_1.docx 18 /
28
1Type of Machine: 1Container Blender 1 Project No. 13565

.1Date of Version: 107. Jan. 2016 1 Version:

7.9. Check BLEND PARAMETER functions

YES NO
confirm,
as checked in previous section
7.9.1. container is positioned into arm and container is clamped => means it is 'x
positioned for blending
confirm,
7.9.2. with pressed key TEST RECIPE the menu is opened X
confirm,
current logged in user "OPERA TOR" is not assigned to enter blend data,
therefore
7.9.3.
change user to "SUPERVISOR",
X
member of this group are enabled to enter blend data in this menu
confirm,
if pressed input box PRODUCT NAME
7.9.4.
screen keyboard is shown, input is possible
'<
confirm,
with input value "ABX-1 ", confirmed by ENTER key,
7.9.5. x
value will be displayed and contains not more than 40 characters
confirm,
with pressed input box PRODUCT NUMBER ')(
7.9.6.
screen keyboard is displayed, input is possible
confirm,
with input value "4711" and confirmed by ENTER key, )(
7.9.7.
value will be display_ed and contains not more than 40 characters
confirm,
7.9.S. if pressed input box BLEND TIME screen keyboard is shown, input is possible 't(
confirm,
input of blend time is limited and value must be within defined range:
{ '?(
7.9.9. if input value "0" min and confirmed by ENTER key,
value will not be acce~ted, value is out of range, input have to be repeated
confirm,
7.9.10.
if input value "100" min and confirmed by ENTER key it will not be accepted, v;
value is out of range, input have to be repeated
confirm,
if input value "5" min and confirmed by ENTER key, value will be accepted ')(
7.9.11.
and shown, it is within possible range of 1 to 99 [minutes]

.. , test continued on next page

Remarks

I. t .
Servolift Customer / Signature
SE=iVOLiFT
I Factory Acceptance Test (FAT)

Type of Machine: Container Blender Project No.

I Date of Version: 107. Jan. 2016 I Version: 1

YES NO

confirm,
with pressed input box BLEND REVERSE TIME
7.9.12.
screen keyboard is displayed, input is possible
'<
confirm,
input of blend reverse time is limited and value must be within defined range:
7.9.13. if input value "100" min and confirmed by ENTER key it will not be accepted, y
value is out of range, input have to be repeated
confirm,
(
7.9.14.
with input value "2" min and confirmed by ENTER key <:
value will be displayed, it is within possible range of 0 to 99 [minutes]
confirm,
if pressed input box BLEND SPEED
7.9.15.
screen keyboard is displayed, input is possible
X'
confirm,
input of blend speed is limited and value must be within defined range:
7.9.16. if input value "4" rpm and confirmed by ENTER key it will not be accepted, -c
value is out of range, input have to be repeated
confirm,
input of blend speed is limited and value must be within defined range:
7.9.17. if input value "16" rpm and confirmed by ENTER key it will not be accepted, y:
value is out of range, input have to be repeated
confirm,
if input value "8" rpm and confirmed by ENTER key
7.9.18. X
value will be accepted and shown, it is within possible range of 5 to 15 rrpml
confirm,
with pressed input box for LEVELLING ....,{
7.9.19.
screen keyboard is displayed, input is possible
( confirm,
input of levelling (time) is limited and value must be within defined range:
7.9.20. if input value "5001" ms and confirmed by ENTER key it will not be accepted, 'X
value is out of range, input have to be repeated
confirm,
if input value "2500" ms (milliseconds) and confirmed by ENTER key, the
7.9.21.
value will be displayed and is within possible range of 0 to 5000 [millisecondl
X

... test continued on next page

Remarks

/J ./J .>
I. t<
IY -
Servolift I S~nature Customer I Signature
SE=iVOLiFT
File: 13565_FAT_1.docx 20/28
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I of Version: 107. Jan. 2016 I Version: 1

Date
YES NO

confirm,
7.9.22.
if pressed input box for BATCH ''1<
the screen keyboard is shown, input is possible
confirm,
with input value "13565-FAT-1" and confirmed by ENTER key, X
7.9.23.
value will be displayed and contains not more than 40 characters
confirm, => if input of BATCH is successful all entered values are shown,
here as summary:
( - PRODUCT NAME set ABX-1
- PRODUCT NUMBER set 4711
- BLEND TIME set 5 min X
7.9.24. - BLEND REVERSE TIME set 2 min
- and
- BLEND SPEED set 8 RPM
- LEVELLING set 2500 ms
- and with BATCH lnamel set "13565-FAT-1"
confirm,
if pressed key EXIT (door symbol) the TEST RECIPE menu is closed,
7.9.25. OPERATOR MENU is indicated again,
X
blend cycle is prepared and can be started in BLEND MENU, => see next test

Remarks

I. 1/.
Sarvolift / Customer / Signature

. - ._. . ... 21/28


File: 13565_FAT_1.docx
SE=lVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: 107. Jan. 2016 I Version: 1

7.10. Check BLEND MENU functions

YES NO

confirm,
7.10.1.
starting at HMI-terminal in OPERATOR MENU :
if pressed key BLEND MENU the menu with blend data is displayed
check and confirm,
7.10.2. user is logged in, user's name is displayed in head line, here "SUPERVISOR" ,K
confirm,
7.10.3. loaded blend data are indicated, entered BATCH value "13565-FAT-1" too .X
( confirm,
7.10.4.
with all start conditions fulfilled the blend cycle can be started,
the key START in BLEND MENU is indicated light grey
-
confirm,
with pressed key START
7.10.5. the rotation starts and blend speed accelerates to selected value, here "8" 'K
rpm (as set before)
confirm,
with pressed key STOP
7.10.6. the running rotation is interrupted, blend speed decelerates to positioning -
speed and arm stops then in 0 turn position, the blend data keep remain
confirm,
with pressed key START again
7.10.7. the interrupted rotation starts with remaining blend time, X
and blend speed accelerates to "8" rpm (as set before)
confirm,
blend process stops after run down of "blend time", here set to "5" min,
)(
7.10.8. positioning starts and then the arm with inserted container stops in 0 turn
position
confirm,
( with finished blend cycle the blend report is printed
(on installed and configured printer),
7.10.9. or printout can be started by touching printer symbol in opened menu,
check and confirm, the report contains preset blend data, as well as time of >'-
start and end of blend sequence, and the interruption by pressed key STOP
confirm,
with blend cycle finished (or interrupted without finishing)
7.10.10. the current menu can be closed: if pressed key EXIT (door symbol), X
the BLEND MENU is closed, OPERATOR MENU become visible
confirm,
7.10.11.
if pressed key MANUAL MODE the submenu with manual functions is
opened
"><

Remarks

Customer / Signature

File: 13565_FAT_1.docx 22728


SE=lVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I of Version: 107. Jan. 2016 I Version:


Date

7.11. Check MANUAL MODE functions, moving back to start position

YES NO
confirm,
blend cycle is finished and supporting arm with inserted container
is still in blend position,
7.11.1. y
means with container clamped in 0 turn position (upright)
and safety door is closed
confirm,
(
in displayed MANUAL MODE menu:
if pressed and hold key UNCLAMP,
7.11.2. )<
unclamping starts, it stops when container is unclamped

confirm,
in displayed MANUAL MODE menu:
7.11.3. if pressed and hold key LOWER, X
lowering starts, it stops when pick up height big container is reached
confirm,
in displayed MANUAL MODE menu:
7.11.4. if pressed and hold key LOWER again, ')<
lowering starts, it stops when min. height is reached
confirm,
7.11.5.
if opened safety door, enter blend area y
the unclamped container can be removed by hand pallet truck
confirm,
7.11.6.
with pressed key EXIT (door symbol)
menu MANUAL MODE is closed, OPERATOR MENU is visible again ><
confirm,
( 7.11.7. if pressed key EXIT again MAIN MENU is displayed '!(

Remarks

Servolift / Customer / Signature

File: 13565_FAT_1.docx 23/28


SE=lVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: 107. Jan. 2016 I Version: 1


7.12. Check MAINTENANCE MENU functions

YES NO
confirm,
y
7.12.1. general power supply is ON (main switch is at ON position)
confirm,
7.12.2. at HMI-terminal the operating language ENGLISH is loaded 'X
confirm,
7.12.3. the MAIN MENU is displayed, and user is still logged in as SUPERVISOR K
confirm,
with pressed key LOGIN in head line,
7.12.4. user identification can be changed to MAINTENANCE, )<
and if entry confirmed the user is logged in, name is shown in head line
confirm,
7.12.5. with pressed key MAINTENANCE MENU the submenus become visible X
confirm,
with pressed key MAINTENANCE MODE
7.12.6.
the menu is indicated with blinking warning and service functions '><
NOTE!
indicated service functions can be operated without any interlocks, therefore
7.12.7. user has to be careful when pressing any key and starting any movement, X
e.g. TURN LEFT/RIGHT may possible without having clamj)_ed the containerl
confirm,
if working in maintenance mode is finished, return the machine back
to its defined start position,
machine then can be operated in "normal" manual mode: 'K
7.12.S.
=> defined start position is reached with following positions fulfilled:
- arm is in 0 turn position (= upright) and in min. height
- swivel clamps unclamped and center cylinder retracted
( confirm,
all fault messages are acknowledged, reset and confirmed
so that closing the displayed MAINTENANCE MODE menu is possible
7.12.9. by pressed key EXIT,
previous menu is displayed and red framed message bar is disappeared and
"normal" operating mode is j)ossible
confirm,
7.12.10 if pressed key EXIT displayed MAINTENANCE MODE menu is closed X
confirm,
with pressed key EXIT again current shown MAINTENANCE MENU is closed,
7.12.11
and the MAIN MENU becomes visible again
'X

Remarks

Customer / Signature

File: 13565_FAT_1.docx 24128


SE=iVOLiFT
I Factory Acceptance Test (FAT)

I Type of Machine: I Container Blender I Project No. 13565

I Date of Version: 107. Jan. 2016 I Version: 1

8. Documentation Check

Pos.: Description Yes No

Owner's manual in English language (1-Fold as paper; 1-Fold on CD)


7.1. X
7.2. Declaration of Com pliance acc. DIN EN 10204- 2.1 - 13565
-c
7.3. Calibration Protocols of Blend Speed and Time X'
( 7.4. Drawing - Blender 13565-00-001 x-
7.5. Drawing - Lift Cylinder 111776 X
7.6. Drawing - Assembly Front Case with Bearing 03-39-203 x-
7.? Drawing - Rotary Unit 7-Fold 03-64-401 X
7.8. Hydraulic Scheme 13565-61-001 x-
7.9. Hydraulic Parts List 13565 K
7.10. Hydraulic Hose List 13565 X
7.11. Spare Parts List 13565 X
7.12. Electric Scheme 13565 'X"
7.13. Electric Parts List 13565 X

7.14. Installation Instruction and Safety Data Sheet of Compound Anchors HILTI )<

7.15. Safety Data Bulletin of Hydraulic Oil FOODMAX


7.16. Safety Data Bulletin of Grease SORAJA )<

7.17. Safety Data Bulletin of Automatic Lubricator PERMA X


7.18. Qualification Documentation consisting of FAT, OQ, IQ, FS, FDS, SDS, HDS Y

Remarks

Servolift / Customer / Signature


SE=iVOLiFT
File: 13565_FAT_1.docx 25/28
SE=lVOLiFT
Factory Acceptance Test (FAT)

Type of Machine: I Container Blender I Project No. 13565

Date of Version: 107. Jan. 2016 I Version:

The documents listed below are available only on CD-Rom after FAT

7.19. PLC-Program of Terminal and Blender Control

7.20. Operating Instructions of Blend Motor and Gear SEW

7.21. Operating Instructions of Frequency Converter DAN FOSS

7.22. Operating Instructions of HMI Terminal

7.23. Parameter Settings of Frequency Converter

7.24. Translation of manual into Portuguese language

Remarks

I. c-:
Servolil Customer / Signature

File: 13565_FAT_1.docx
Type of Machine: I Container Blender I Project No. 13565

Date of Version: 107. Jan. 2016 I Version: 1

9. List of Deviations I Repair work


All defects, which are detected during FAT tests, are listed below together with the necessary actions
to eliminate the defects.

No. Defect I Measure to eliminate Response

L
/
L
V
/
/
/
/
-:
/
//
/
/
L
(
.:
/
/
-:
/

Remarks

I. "".
Customer / Signature

File: 13565_FAT_1.docx 27 (28


I Factory Acceptance Test (FAT)

I of Machine: I Container Blender I Project No. 13565


I
Type
of Version: I07.Jan.2016 I Version: 1

Date
10. Final Statement
Remark:
/
.>
/
/'
/'
/'
/'
/'
/'
/'
/'
/'
/'
/'
/'
{
-:
I~
YES NO

Machine has stand factory approval: >>('

Machine is release for shipment )(

Remarks

I. 1/,
Servolift / Customer / Signature
File: 13565_FAT_1.docx 28/28
SE=iVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma taboratorlos SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1 Date of Version: 122. Dec 2015 1 Version: 1

OPERATION QUALIFICATION
for
Container- Blender

Eurofarma Laboratorios S.A.,


Itapevi - Sao Paulo,
Brazil

Supplier Name / Signature Position Date

Written by:
Mr. R. ~~er

Sig:
/' 1', ~
~

.
, Electrical
i-'programming dept.
22. Dec. 2015

Ms. M''ffttk~.~ Electrical


Reviewed by: 22. Dec. 2015
(
Sig: (0 ~f. editorial dept.
Mr. C. Harms
Asst. manager
t--:,~, /\
' I
Approved by: 22. Dec. 2015
SiIg:. ,I c-: ..,.'{... electrical dept.

Customer Name / Signature Position Date

Reviewed by:
Sig:

Reviewed by:
Sig:

Approved by:
Sig:

13565_OQ_1_E.docx 1/
66
SE=...lVOLiFT
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Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

I Date of Version: 122. Dec 2015 1 Version: 1

Version control - Change history - Change control

this page will be revised each time the specification is revised and re-issued, to record the dates and
reason for issue. All changes of this document (either for review or approval) are registered in this list.

Change Date Editor Reason for Change

1 22. Dec 2015 BR initial version

13565_OQ_1_E.docx 2/
66
SE=tVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratorios SA, Itapevi - C t R f


4500233630
Customer: Sao Paulo, Brazil us omer e erence

1Date of Version: 122. Dec 2015 1Version: 1

Table of Contents

1. Introduction 6
1.1. Author 6
1.2. Objective of this document 6
1.3. Reference Document(s} 6

2. Control ON 7
2.1. Control ON, general procedure 7

3. Access control I Password Management 8


3.1. Login / put in user identification of "OPERATOR" level 8
3.2. Login / put in user identification of "SUPERVISOR" level 10
3.3. Login / put in user identification of "MAINTENANCE" level 11
3.4. Login / put in user identification of "ADMINISTRATOR" level 12
3.5. Automatic logoff as preset 13

4. Prepare for blending (blend position, blend data) 15


4.1. Procedure as follows (with 1600L container} 15
4.2. Input of blend parameter / preparing blend cycle 17
-,
5. Safety components I Check alarm messages 19
( 5.1. HMI-MESSAGE ID NO.3: EMERGENCY STOP (E-STOP) HMI PRESSED 19
5.2. HMI-MESSAGE ID NO. 26: E-STOP MODULE NOT ACTiVE 21
5.3. HMI-MESSAGE ID NO. 54: COMMUNICATION BETWEEN PLC <=> HMIINTERRUPTED 22
5.4. HMI-MESSAGE ID NO. 82: TEMPERATURE HYDRAULIC OIL EXCEED 24
5.5. HMI-MESSAGE ID NO. 48: MAIN POWER SUPPLY LOST 25
5.6. HMI-MESSAGE ID NO.1: FUSE 24V DC GENERAL SWITCHED OFF 27
"

5.7. HMI-MESSAGE ID NO. 20: SAFETY DOOR 1 OPEN 29


5.8. HMI-MESSAGE ID NO. 24: FUSE / OVERLOAD RELAY SWITCHED OFF 31
5.9. HMI-MESSAGE ID NO. 84: TEMPERATURE BLEND MOTOR 1 EXCEED 33
5.10. HMI-MESSAGE ID NO. 88: FAILURE FREQUENCY CONVERTER BLEND MOTOR 34
5.11. HMI-MESSAGE ID NO. 41: TIMEOUT 0 PROXIMITY SWITCH FLAG 35
5.12. HMI-MESSAGE ID NO. 42: FAILURE 0 PROXIMITY SWITCH 36
5.13. HMI-MESSAGE ID NO. 65: CONTAINER NOT IN POSITION 37
5.14. HMI-MESSAGE ID NO. 66: CONTAINER NOT CLAMPED 38
.-
5.15. HMI-MESSAGE ID NO. 74: TIMEOUT AUTO CLAMP (BLENDING/CALIBRATION) 39
5.16. HMI-MESSAGE ID NO. 33: ARM NOT AT BLEND HEIGHT .40
5.17. HMI-MESSAGE ID NO. 49: TIMEOUT SENSOR AT SPROCKET 41

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66
SE=lVOLiFT
r:: .: I "~ ~ ~l""''' : .:/ ....)."

Operational Qualification (OQ)


Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

I Date of Version: 122. Dec 2015 1Version: 1

5.18. HMI-MESSAGE ID NO. 50: FAILURE MAINS CONTACTOR HYDRAULIC PUMP 43

6. Bring container back to min height 44


6.1. Procedure as follows (1600L container) 44

7. Functional Sequence(s) 45
7.1. Blending (with 1600L container) .45
1.2. Maintenance mode / sequence 48

8. Adjustments 51
8.1. SUPERVISOR MENU - RECIPE MANAGEMENT 52
8.2. ADMINISTRATOR MENU - PASSWORD I USER MANAGEMENT 57
8.3. TERMINATE I SHUTDOWN RUNNING APPLICATION 64

9. List of Deviations I repair work 65


10. Final Statement 66

13565_OQ_1_E.docx 4/
66
SE=JVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender J Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1 Version: 1

list of persons, involved in qualification:

Responsible
Person:

Name Company Date Signature acronym

Name Company Date Signature acronym

Name Company Date Signature acronym

Name Company Date Signature acronym

Name Company Date Signature acronym

Name Company Date Signature acronym

Name Company Date Signature acronym


SE=lVOLiFT
'Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1Date of Version: 122. Dec 2015 1Version: 1

.'
1. Introduction
1.1. Author
This document is the Operational Qualification (OQ). It presents the basic test procedures
to carry out the single functional tests of the Container Blender 13565 as given in the contract.
This document is written and approved by SERVOLIFT GmbH, Germany.

1.2. Objective of this document


The objective of this document is the description of procedures and acceptance criteria
according to the SERVOLIFT standard to show machine is working as described in FS I FDS.

"
1.3. Reference Document(s)

Document Version (current indices)

Functional Specification 13565_FS-FDS

Drawing Container Blender 13565-00-001

Hardware Design Specification HDS 13565_HDS

Hardware - Assignment of sensors I actua-


tors to Input I Output Cards of PLC 13565_HDS-10-List

(
SE=iVOLiFT
Operational Qualification (OQ)

Type of Machine: IContainer Blender I Servolift Project No. 1 13565

Eurofarma l.aboratorlos SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us orner e erence 4500233630

1 Date of Version: 122. Dec 2015 1 Version: 1

2. Control ON
The following test is a general test and it shows that functional sequences can be started
from operator panel located outside blend room, after having switched ON general power supply.
2.1. Control ON, general procedure

item Description I Start condition Acceptance criteria YES NO


at electric cabinet general power supply is ON,
2.1.1. Initialization of HMI starts
turn main switch to ON position
confirm, with general control
2.1.2. switched to ON position when initialization is finished, operating
language PORTUGUESE is loaded
initialization of HMI-terminal starts
confirm, if pressed key with na- after having pressed key with national
2.1.3. tional flag operating language flag for ENGLISH language all texts are
can be changed to ENGLISH changed, MAIN MENU is displayed
user's name is not shown
confirm, at this moment
2.1.4.
no user is logged in . IUSER
at the head line : = I
communication status between PLC

I.~
and HMI is indicated
confirm, at head line ...
/ 2.1.5. only communication status ... by blinking green symbol:
I
between PLC and HMI is shown
IlDlS
defined position means:

2.1.6.
check and confirm, - arm is in min. height
blender is in "defined" position - safety door is closed
- container type 1600L is available
2.1.7. TEST FINISHED

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 7/66
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1Version:


1

s, Access control I Password Management


The operation at installed HMI-terminal is protected by a user administration with password inquiry.
All operating- and input interfaces are interlocked by password protected access levels. To inhibit unauthorized
use of the machine, the system provides a user access security. All run-to-use screen elements (text, value,
etc.) that affect plant safety, respectively, a movement are locked by means of access protection. To operate
the machine, the user has to log in at the HMI-terminal by entering: => Username and => Password.

The system will be preconfigured with different access levels:

(user-) Group enter into entry field: User enter into entry field: Password
ADMINISTRATOR ADMIN1 ADMIN1
SUPERVISOR SUPERVISOR SUPERVISOR
MAINTENANCE MAINTENANCE MAINTENANCE
OPERATOR OPERATOR OPERATOR
,
The following tests show how to log in for each user group and which functionality is assigned.

3.1. Login I put in user identification of "OPERATOR" level

item Description I Start condition Acceptance criteria YES NO


(, !
user Logon dialog and
3.1.1. press key LOGIN. screen keyboard are displayed
displayed in the head line
touch input box "User" and put in
3.1.2. user name "OPERATOR", user name is entered and confirmed
confirm input by ENTER (.J) key
user password is entered
touch input box "Password" and confirmed, Note: password is not
3.1.3. and put in "OPERATOR",
readable at screen (hidden),
confirm input by ENTER key
it's shown as "***,,
user name "OPERATOR"
3.1.4. close Logon dialog with OK
is displayed at the head line

... continued on next page

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 8/
66
SE=tVOLiFT
.... .. -. :.' ~'-:

Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma l.aboratorlos SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1 Version: 1

item Description I Start condition Acceptance criteria YES NO


check and confirm, user is enabled
3.1.5. if pressed key OPERA TOR MENU to open and close OPERATOR
the submenus will displayed MENU
check and confirm,
user is enabled to open and
3.1.6. if pressed key MANUAL MODE
close MANUAL MODE menu
available functions are indicated
press key (blue, blinking)
3.1.7. safety module is switched on
ACTIVATE SAFETY CIRCUIT
with pressedone of bothkeys
a blueframedmessagebar is
check and confirm, with pressed displayed: "ARMNOTAT
3.1.8. key TURN RIGHT or TURN LEFT MAXHEIGHT",
operating by this user is possible
=> this showsuseris assignedto startthis
function
but neededstartconditionsare not fulfilled
press key EXIT (door symbol) menu MANUAL MODE is closed,
3.1.9. to close displayed menu OPERATOR MENU is displayed
3.1.10. press key EXIT again MAIN MENU is indicated again

3.1.11. TEST FINISHED

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 9/
66
5E~VOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1 Date of Version: 122. Dec 2015 1 Version: 1

3.2. Login I put in user identification of "SUPERVISOR" level

item Description I Start condition Acceptance criteria YES NO

3.2.1. press key LOGIN :;;,


displayed in the head line
l user Logon dialog and
screen keyboard are displayed

touch input box "User" and put in


user name
3.2.2. user name "SUPERVISOR",
is entered and confirmed
confirm input by ENTER key
user password
touch input box "Password"
is entered and confirmed
3.2.3. and put in "SUPERVISOR",
Note: password is not readable at screen
confirm input by ENTER key
(hidden), it's shown as "***"
user "OPERATOR" is logged out
3.2.4. close Logon dialog with OK and user name "SUPERVISOR"
is displayed at the head line
check, if pressed
3.2.5. submenus become visible
key SUPERVISOR MENU
check, with pressed key
3.2.6. corresponding menu is opened
RECIPE MANAGEMENT ...

3.2.7.
check, if key with arrow down c:J] displayed dialog is closed, blend data
is pressed of "Sample RECIPE" become visible
an recipe dataset can be selected
menu RECIPE MANAGEMENT is
closed,
3.2.8. press key EXIT
SUPERVISOR MENU is displayed
again
3.2.9. press key EXIT again MAIN MENU is indicated again

3.2.10. TEST FINISHED

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 10/66
SE=1VOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

I Date of Version: 122. Dec 2015 1 Version: 1

3.3. Login I put in user identification of "MAINTENANCE" level

item Description I Start condition Acceptance criteria YES NO


(
3.3.1.
(I l user Logon dialog and
press key LOGIN _.. screen keyboard are displayed
displayed in the head line
touch input box "User" and put in
user name
3.3.2. user name "MAINTENANCE",
is entered and confirmed
confirm input bv ENTER key
user password
touch input box "Password"
is entered and confirmed
3.3.3. and put in "MAINTENANCE",
confirm input by ENTER key Note: password is not readable at screen
(hidden), it's shown as ".....".

3.3.4. user name "MAINTENANCE"


close Logon dialog with OK is displayed at the head line
check and confirm, if pressed
user is enabled to open and close
3.3.5. key MAINTENANCE MENU
MAINTENANCE MENU
the submenus will displayed
check and confirm, menu is opened,
if pressed a warning is displayed,
3.3.6. key MAINTENANCE SETTINGS user is enabled to press key CON-
menu is opened FIRM HMI-MESSAGE so that mes-
and operating within is possible sage is confirmed and closed
(
press key EXIT (door symbol) menu is closed,
3.3.7. to close displayed menu MAINTENANCE MENU is displaved
press key EXIT again menu is closed,
3.3.8. to return to MAIN MENU MAIN MENU is displayed
3.3.9. TEST FINISHED

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 11/66
SE=tVOLiFT
, ,.::iti': ~:l,;>;.,r;:,

Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1Date of Version: 122. Dec 2015 1Version: 1

3.4. Login I put in user identification of "ADMINISTRATOR" level

item Description I Start condition Acceptance criteria YES NO


.t.,. .
3.4.1. user Logon dialog and
press key LOGIN _ screen keyboard are displayed
displayed in the head line
touch input box "User" and put in
user name
3.4.2. user name "ADMIN1 to,
is entered and confirmed
confirm input by ENTER key
user password is entered
touch input box "Password"
3.4.3. and put in password "ADMIN1", and confirmed
confirm input by ENTER key Note: password is not readable at screen
(hidden), it's shown as "***,,
user name "ADMIN1"
3.4.4. close Logon dialog with OK
is displayed at the head line
check and confirm, ADMINISTRATOR MENU
3.4.5. if pressed key ADMIN MENU is opened,
the submenus will displayed submenus become visible
che ck and confirm, if pressed key
. the USER MANAGEMENT menu

c
3.4.6. is opened, an overview of preset user
the submenu will opened and user groups is displayed
check and confirm, with touch input field
if touched any input field, screen keyboard is shown
e.g. logoff time and value is changeable,
3.4.7. of user "SUPERVISOR" e.g. to 1 minute,
which shows "5" min, if pressed ENTER change is saved,
modification is possible if pressed EXIT menu is closed
press key EXIT (door symbol) menu is closed,
3.4.8. in the end MAIN MENU is shown
to close displayed menu
3.4.9. TEST FINISHED

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 12 /
66
5E=JVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1Version: 1

3.5. Automatic logoff as preset

item Description I Start condition Acceptance criteria YES NO


user Logon dialog and
in displayed MAIN MENU screen keyboard are displayed,
press key LOGIN again with successful input
3.5.1. displayed in the head line user's name "SUPERVISOR"
and put in is displayed in head line,
user identification for SUPERVISOR note time shown in head line,
e.g. 10:24:10
if time of 1 minute was run over
wait 1 minute and compare present time on HMI,
don't touch any key at HMI-terminal, e.g. 10:25:10,
3.5.2. if time is elapsed
current logged in user SUPERVISOR
check that the current user was logged out,
is logged out automatically so that no user is logged in again
menu is opened,
3.5.3. press key ADMIN. MENU
overview list is displayed
compare both time stamps,

one line contains


confirm, in overview list
"User 'SUPERVISOR' logged on with
both the login action and
3.5.4. the automatic logout action group 'SUPERVISOR'
( is recorded / listed and

other line shows "user logged off",


difference should show 1 minute
... test continued on next page

Remarks
SE=iVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

I Date of Version: 122. Dec 2015 1Version: 1

item Description I Start condition Acceptance criteria YES NO

now reset automatic logoff time


of user "SUPERVISOR"
( back to 5 minutes:

therefore do following steps:


1. press key LOGIN
2. login as ADMIN1
3. call ADMIN. MENU with done all steps successfully
4. call USER MANAGEMENT the automatic logoff time
(. of user "SUPERVISOR"
3.5.5.
menu _ is set back to 5 minutes
and starts after next login
5. search user SUPERVISOR in with this user identification
overview list and 4th column
with value 1 minute
6. touch value, and change to 5
7. confirm change by ENTER
8. close menu by EXIT key
9. close ADMINISTRATOR MENU
also by EXIT key

close displayed menu,


3.5.6. MAIN MENU is displayed again
press key EXIT (door ~ymbol)
press key LOGOFF so that curre t current user ADMIN1 is logged off,
3.5.7.
user Is logQed out manually no user is logged in at the moment
3.5.8. TEST FINISHED

Remarks

confirmed / signature confirmed I signature


13565_OQ_1_E.docx 14 /
66
SE=tVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1Date of Version: 122. Dec 2015 1Version: 1

4. Prepare for blending (blend position, blend data)


This test is used for positioning the 1600L container at blend position and to prepare blend cycle.

,4.1. Procedure as follows (with 1600L container)

item Description I Start condition Acceptance criteria YES NO


defined position means:
- arm is in min. height
4.1.1. check and confirm,
blender is in "defined" position - in 0 turn position
- with clamp system unclamped
- safety door is closed
at HMI terminal,
4.1.2. starting from MAIN MENU available submenus become visible
press key OPERATOR MENU
4.1.3. press key MANUAL MODE manual functions become visible

confirm, user is logged in,


user's name "SUPERVISOR"
4.1.4. if not, please put in user ID
is shown in the head line
(as described in chapter 2)

lifting starts
4.1.5. press and hold key LIFT and stops
at pick up height big container

go into blend room, insert 1600L


4.1.6. container container is in position
by help of hand pallet truck

4.1.7. remove hand pallet truck hand pallet truck is removed

close safety door and go to HMI


4.1.8. panel safety door is closed

Remarks

confirmed / signature confirmed I signature


13565_OQ_1_E.docx 15 /
66
SE=iVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1 Date of Version: 122. Dec 2015 1 Version: 1

,
item Description I Start condition Acceptance criteria YES NO

at HMI panel:
4.1.9. press key (blue, blinking) safety module is switched on
ACTIVATE SAFETY CIRCUIT

lifting starts and stops when


4.1.10. press and hold key LIFT again max. height ( =blend height)
is reached
inserted container will be clamped,
4.1.11. press and hold key CLAMP function stops automatically
if needed clamp pressure is reached
4.1.12. TEST FINISHED

Remarks

confirmed I signature confirmed / signature


13565_OQ_1_E.docx 16/66
SE=JVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1Version: 1

4.2. Input of blend parameter I preparing blend cycle


At the following test it is necessary to select I enter blend data to be able to check
following safety functions during rotation or active movement.

( item Description I Start condition Acceptance criteria YES NO

starting from MAIN MENU


4.2.1. press key OPERATOR MENU available submenus become visible
confirm, user is logged in,
user's name "SUPERVISOR"
4.2.2. if not, please put in user ID
is shown in the head line
(as described in chapter 2)
submenus become visible:
MANUAL MODE
at HMI-terminal: PARAMETER MENU
4.2.3.
OPERA TOR MENU is displayed TEST RECIPE
BLEND MENU and
BATCH ARCHIVE by symbol _&
menu is loaded, input of single parameter
4.2.4. press key TEST RECIPE is possible and required
4.2.5. touch input box PRODUCT NAME screen keyboard is displayed
put In value "ABX-1"
value is entered and confirmed,
4.2.6. and confirm by ENTER key
it contains maximum 40 characters
on displayed screen keyboard
( touch input box
4.2.7. screen keyboard is displayed
PRODUCT NUMBER
put in value "4711" value is entered and confirmed,
4.2.8.
and confirm by ENTER key it contains maximum 40 characters
4.2.9. select input box for BLEND TIME screen keyboard is displayed
check input out of range: value is not correct,
4.2.10. put in value "0" min advice message is displayed,
and confirm byENTER key input has to be repeated in valid ranue
check input out of range: value is not correct,
4.2.11. put in value "100" min advice message is displayed,
and confirm by ENTER key input has to be repeated in valid range
put in value "30" min value is entered
4.2.12.
and confirm by ENTER key within range 1 to 99 [minutes]

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 17/6
6
SE~VOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servo lift Project No. 1 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1Date of Version: 122. Dec 2015 1Version: 1

_. _

item Description I Start condition Acceptance criteria YES NO

select input box


4.2.13. for BLEND REVERSE TIME screen keyboard is displayed
check input out of range: value is not correct,
4.2.14. put in value "100" min advice message is displayed,
and confirm by ENTER key input has to be repeated in valid ranee
put in value "5" min value is entered
4.2.15. within range 0 to 99 [minutes]
and confirm by ENTER key
4.2.16. go to input box BLEND SPEED screen keyboard is displayed
check input out of range, value is not correct,
4.2.17. lower value: put in value "4" rpm advice message is displayed,
and confirm by ENTER key input has to be repeated in valid ranee
check input out of range: value is not correct,
4.2.18. higher value: put in value "16" rpm advice message is displayed,
and confirm by ENTER key input has to be repeated in valid ranae
value is entered
4.2.19. put in value "10" rpm within range 5 to 15 [rpm] and confirmed
and confirm by ENTER key
select input box for LEVELLING
4.2.20. screen keyboard is displayed
(defines angle after 0 position)
check input out of range: value Is not correct,
4.2.21. put in value "5001" ms advice message is displayed,
and confirm bv ENTER key input has to be repeated in valid ranae
put in value "2500" ms value is entered within range 0 to 5000
4.2.22. and confirm by ENTER key [millisecond] and confirmed
4.2.23. select input box for BATCH screen keyboard is displayed
put in value "13565-00-1"
value is entered and confirmed,
4.2.24. and confirm by ENTER key it contains maximum 40 characters
on displayed screen keyboard
menu TEST RECIPE is closed,
4.2.25. press key EXIT (door symbol)
OPERATOR MENU is disolaved
4.2.26. press key EXIT again MAIN MENU is indicated again

4.2.27. TEST FINISHED

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 18/6
6
SE=iVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1 Date of Version: 122. Dec 2015 1 Version: 1

S. Safety components I Check alarm messages


At the following section the testing of safety components is carried out so it is ensured that operators are
protected from risk during set up, during production or during the correction of faults. It is intended to show
~~e effect of a malfunction to the running sequence, the possibility to remedy the malfunction and
( the steps to continue interrupted sequence.

5.1. HMI-MESSAGE 10 NO.3: EMERGENCY STOP (E-STOP) HMI PRESSED


item Description I Start condition Acceptance criteria YES NO

starting in MAIN MENU


5.1.1. press key OPERA TOR MENU available submenus are shown
confirm, user is logged in,
5.1.2. if not, please put in user ID user's name "SUPERVISOR"
(as described in chapter 2) is shown in the head line
defined position means:

check and confirm,


- arm is at blend height
5.1.3. blender is in "blend" position - in 0 turn position
0

- inserted container is clamped


- safety door is closed
5.1.4. press key MANUAL MODE manual functions are displayed
rotation starts
5.1.5. press and hold key TURN RIGHT
until pressed key is released
during rotation
5.1.6. press e-stop button beside HMI confirm,
a message bar shows "ALARM"

5.1.7. unlock pressed e-stop key e-stop is unlocked

5.1.8. touch message bar "ALARM" menu ALARM becomes visible,


[ "'1.1 D D cy fault message is indicated

5.1.9.
press key 0 [CONFIRM]
message is confirmed,
key RESET will be enabled, is light grey

5.1.10. press key RESET message is confirmed and cleared

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 19 /
66
SE=lVOLiFT
.:?; :"', ... :ltd . 1",

'Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1 Version: 1

item Description I Start condition Acceptance criteria YES NO


return from menu ALARM
5.1.11. press key EXIT (door symbol)
to menu MANUAL MODE
press key (blue, blinking) safety module is switched on,
( 5.1.12.
ACTIVATE SAFETY CIRCUIT sequence can be continued
rotation starts,
5.1.13. press and hold key TURN RIGHT it stops either after next overrun of 0
turn position or if key is released

5.1.14. TEST FINISHED

Remarks
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1 Date of Version: 122. Dec 2015 1 Version: 1

5.2. HMIMESSAGE ID NO. 26: ESTOP MODULE NOT ACTIVE

item Description I Start condition Acceptance criteria YES NO


confirm, possible function will be
5.2.1. menu MANUAL MODE is shown TURN LEFT / TURN RIGHT
(
defined position means:

check and confirm,


- arm is at blend height
5.2.2. blender is in "blend" position - in 0 turn position
- inserted container is clamped
- safety door is closed
simulate a malfunction
of e-stop I safety module (10A1) if connection at e-stop module 1 OA1
5.2.3. - press key TURN RIGHT and pin 18 is interrupted
- disconnect connection wire at rotation stops and
module 1 OA1 pin 18 a message bar shows "ALARM"
during running rotation
re-connect connection wire connection wire at e-stop module
5.2.4. at module 10A1 pin 18 1OA1 pin 18 is connected
touch message bar "ALARM" menu ALARM becomes visible,
5.2.5.
L ~'..:_i!l.r.'lJQJ fault message is indicated
message is confirmed,
5.2.6.
press key .LJ- [CONFIRM] key RESET will be enabled, is light grey
5.2.7. press key RESET message is confirmed and cleared
(
5.2.8. press key EXIT (door symbol) return to menu MANUAL MODE
rotation starts,
5.2.9. press and hold key TURN RIGHT it stops either after next overrun of 0
turn position or if key is released
5.2.10. press key EXIT (door symbol) MANUAL MENU is shown again

5.2.11. TEST FINISHED

Remarks

confirmed I signature confirmed / signature


13565_OQ_1_E.docx 21/66
SE=iVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I 5ervolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1Date of Version: 122. Dec 2015 1Version: 1

5.3. HMIMESSAGE 10 NO. 54: COMMUNICATION BETWEEN PLC <=> HMIINTERRUPTED


item Description I Start condition Acceptance criteria YES NO

confirm
5.3.1. submenus become visible
MANUAL MENU is still dis la ed
defined position means:
arm is at blend height
check and confirm,
5.3.2. in 0 turn position
b~nder~in"~end"posWon
inserted container is clamped
safet door is closed
confirm, user is logged in,
user's name "SUPERVISOR"
5.3.3. if not, please put in user 10
is shown in the head line
as described in cha ter 2
BLEND MENU is indicated with blend
in displayed OPERATOR MENU:
5.3.4. data as entered, key START
press key BLEND MENU
is shown enabled =
Ii ht re
rotation starts and
5.3.5. press key START
accelerates to selected blend seed
simulate communication error MPI-plug is disconnected,
between PLC and HMI-terminal but no message is displayed
5.3.6. => disconnect MPI-plug at HMI-terminal,
at PLC (15A2) located inside elec-
tric cabinet and wait 15 seconds
wait 15 seconds and
5.3.7.
then re-connect MPI- lu to PLC

touch message bar "ALARM" menu ALARM becomes visible,


5.3.8.
AI AI~I\I ~ fault message is indicated

message is confirmed,
5.3.9.
press key [[J [CONFIRM] key RESET will be enabled, is light grey

5.3.10. press key RESET message is confirmed and cleared

5.3.11. return from menu ALARM


press key EXIT (door symbol)
to menu BLEND MENU
Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 22/66
SE=iVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1 Version: 1

item Description I Start condition Acceptance criteria YES NO


the communication status
between PLC and HMI-terminal

status of communication is shown


r~;bl~~;S~
is shown at head line by
confirm, in head line of displayed
5.3.12. BLEND MENU
5.3.13. press key EXIT (door symbol) return to OPERATOR MENU

5.3.14. TEST FINISHED

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 23/66
SE=iVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565


Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 23/66
SE=lVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servolift Project No. 13565

Eurofarma Laboratories SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1Date of Version: 122. Dec 2015 1Version: 1

5.4. HMI-MESSAGE ID NO. 82: TEMPERATURE HYDRAULIC OIL EXCEED

item Description I Start condition Acceptance criteria YES NO


defined position means:
( check and confirm,
- arm is at blend height
5.4.1.
blender is in "blend" position - in 0 turn position
- inserted container is clamped
- safety door is closed
5.4.2. press and hold push button UNCLAMP function starts
simulate increased temperature
of hydraulic oil during
hydraulic function is executed with disconnecting temp. contact
at hydraulic power pack
5.4.3. ~ during running hydraulic function running hydraulic function stops
disconnect the plug and
of temperature contact 5S3 a message bar shows "ALARM" at HMI
at hydraulic power pack
(alternatively at terminals X17 -2)
re-connect plug of temp. contact plug of temp. contact at hydraulic
5.4.4. at hydraulic power pack power pack is connected
touch message bar "ALARM" menu ALARM becomes visible,
5.4.5.
I -: M:-~~n_QI fault message is indicated

5.4.6.
press key 0 [CONFIRM]
message Is confirmed,
key RESET will be enabled, is light grey

5.4.7. press key RESET message Is confirmed and cleared


return from menu ALARM
S.4.S. press key EXIT (door symbol)
to MANUAL MODE
clamping starts again, it stops when
5.4.9. press and hold push button CLAMP needed clamp pressure is reached
MANUAL MODE menu is closed,
5.4.10. press key EXIT (door symbol) again OPERATOR MENU is displayed
5.4.11. TEST FINISHED

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 24/66
SE=1VOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. 1 13565

Eurofarma Laboratorlos SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1 Date of Version: 122. Dec 2015 1 Version: 1

5.5. HMI-MESSAGE ID NO. 48: MAIN POWER SUPPLY LOST

item Description I Start condition Acceptance criteria YES NO


defined position means:

( check and confirm,


- arm is at blend height
5.5.1. blender is in "blend" position
- in 0 turn position
0

- inserted container is clamped


- safety door is closed
menu is opened,
BLEND MENU is indicated,
5.5.2. press key BLEND MENU
blend time is not elapsed, key START
is shown enabled (= light grey)
rotation starts and
5.5.3. press key START
accelerates to selected blend speed
if main power supply is OFF
simulate a power loss while blending
the rotation stops
5.5.4. by interruption main power supply,
=> turn main switch OFF and no movement is possible,
the HMI is switched off, display dark
initializing
wait 15 seconds of PLC and HMI-terminal starts,
5.5.5. and then turn main switch ON PORTUGUESE language
is loaded as operating language
after having pressed
key with national flag it changes
5.5.6. press key with national flag and from PORTUGUESE to ENGLISH,
change language to ENGLISH
the MAIN MENU is displayed,
no user is logged in
if MAIN MENU is displayed again user Logon dialog and
5.5.7. press key LOGIN to put in user 10 screen keyboard are displayed
enter password "SUPERVISOR" and after successful login user's name is dis-
5.5.B. confirm input by ENTER key, close played in head line and can continue the
dialog by OK key test I the sequence
touch message bar "ALARM" menu ALARM becomes visible,
5.5.9.
I .: .!f4lP U ~ fault message is indicated
message is confirmed,
5.5.10.
press key ~ [CONFIRM] key RESET will be enabled, is light grey
5.5.11. press key RESET message is confirmed and cleared

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 25 /
66
SE=iVOLiFT
"I ,e. .: .;;", ,".
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1 Date of Version: 122. Dec 2015 1 Version: 1

item Description I Start condition Acceptance criteria YES NO


return
5.5.12. press key EXIT (door symbol)
from menu ALARM to MAIN MENU
submenus become visible, if menu is
( 5.5.13. press key OPERATOR MENU
opened sequence can be continued
menu is opened,
5.5.14. press key BLEND MENU
sequence can be continued
press key (blue, blinking)
5.5.15. safety module is switched on
ACTIVATE SAFETY CIRCUIT
5.5.16. press key START sequence is continued

rotation is Interrupted,blender is positioning


5.5.17. press key STOP and stops in 0 turn pos.
0

BLEND MENU is closed,


5.5.18. press key EXIT (door symbol)
OPERA TOR MENU is displayed
5.5.19. TEST FINISHED

Remarks
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1 Date of Version: 122. Dec 2015 1 Version: 1

5.6. HMI-MESSAGE 10 NO.1: FUSE 24V DC GENERAL SWITCHED OFF


ATTENTION: DURING THE APPEARANCE OF THIS MESSAGE (10 NO.1), DIFFERENT FOLLOW-UP
MESSAGES MAY OCCUR. CONFIRM ALL MESSAGES TO CONTINUE OPERATIONAL SEQUENCE.

( item Description I Start condition Acceptance criteria YES NO


blend position means: as described in
item "prepare for blending (blend posi-
check and confirm,
5.6.1. blender is in "blend" position tion, blend data)" = arm at blend height
with inserted container clamped and
safet door closed
check and confirm,
user's name "SUPERVISOR"
5.6.2. user is logged in as described
is shown in the head line
in cha ter "Access control"
BLEND MENU is indicated, blend time
in displayed OPERATOR MENU
5.6.3. is not elapsed, key START is shown
press key BLEND MENU
enabled =
Ii ht re
rotation starts and
5.6.4. press key START
accelerates to selected blend seed

simulate a malfunction of protec-


tion component, => fuse 2F3 after having switched off the fuse the
5.6.5. caused by overcurrent, rotation stops and
a message bar shows "ALARM"
=> turn fuse off manually

5.6.6. switch fuse on again fuse is on

touch message bar "ALARM"


5.6.7. AI AI(I\I ~ menu ALARM becomes visible,
fault message is indicated

5.6.8. message is confirmed,


key RESET will be enabled, is light grey
5.6.9. press key RESET message is confirmed and cleared
return from menu ALARM
5.6.10. press key EXIT (door symbol)
to BLEND MENU

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 27 /
66
:r: " .:: ;;: ' ,1."

Operational Qualification (OQ)


Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratorlos SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

! Date of Version: !22. Dec 2015 ! Version: 1

item Description I Start condition Acceptance criteria YES NO

5.6.11. press key START sequence is continued


rotation is interrupted, blender is positioning
( 5.6.12. press key STOP
and stops in 00 tum pos.
5.6.13. TEST FINISHED

Remarks
SE=lVOLiFT ". : '!..-:~ ~ '; '. -, :J ",

Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

I Date of Version: 122. Dec 2015 1 Version: 1

5.7. HMI-MESSAGE 10 NO. 20: SAFETY DOOR 1 OPEN

item Description I Start condition Acceptance criteria YES NO

defined position means:


( arm is at blend height
check and confirm,
5.7.1. in 0 turn position
blender is in "blend" position
inserted container is clamped
safet door is closed
check, user is logged in,
if not, please put in user ID user's name "SUPERVISOR"
5.7.2. (as described in section is shown in the head line
Access control
in displayed BLEND MENU:
5.7.3. rotation starts and
press key START
accelerates to selected blend speed
simulate a malfunction
of safety door when safety door contact
5.7.4. by disconnecting at safety sensor is disconnected the rotation stops
1 OA1 contact 32 and
Ic in ut 125.4 a message bar shows "ALARM"
if pressed any key in displayed menu
check and confirm, as long as no movement starts,
5.7.5. fault is present and not remedied cause machine in disturbance,
the machine cannot be restarted it is indicated by blue framed mes-
sage:
"SAFETY DOOR NOT CLOSED"
re-connect safety door contact (pic
5.7.6. connection is done / door is closed
input 125.4) or close door
menu ALARM becomes visible,
touch message bar "ALARM"
5.7.7. fault message is indicated with ID 20
AI~l
and text "SAFETY DOOR 1 OPEN"
message is confirmed,
5.7.B.
press key Cd: [CONFIRM] key RESET will be displayed light grey

5.7.9. press key RESET message is confirmed and cleared

Remarks
SE=iVOLiFT
~"i":'i::'
::, ',;, (.F:-)".: f'!;,

Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratorlos SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

I Date of Version: 122. Dec 2015 1 Version: 1

item Description I Start condition Acceptance criteria YES NO

return
5.7.10. press key EXIT (door symbol)
from menu ALARMS to BLEND MENU
( press key (blue, blinking)
5.7.11. safety module is switched on
ACTIVATE SAFETY CIRCUIT
rotation starts and
5.7.12. press key START
accelerates to selected blend speed

rotation is interrupted, blender is


5.7.13. press key STOP positioning and stops in 0 tum pos.

5.7.14. TEST FINISHED

Remarks
SE=iVOLiFT
.1.;..... _',;,
:.7: .: ;".!.J';.

Operational Qualification (OQ)


Type of Machine: I Container Blender I Servolift Project No. 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: 4500233630
Sao P au I0, B
razi'1 us omer e erence

I Date of Version: 122. Dec 2015 1 Version: 1

5.8. HMI-MESSAGE 10 NO. 24: FUSE I OVERLOAD RELAY SWITCHED OFF


item Description I Start condition Acceptance criteria YES NO
defined position means:
( - arm is at blend height
5.8.1. check and confirm,
- in 0 turn position
blender is in "blend" position
- inserted container is clamped
- safety door is closed

check and confirm,


user's name "SUPERVISOR"
5.8.2. user is logged in as described
in chapter "Access control" is shown in the head line

5.8.3. rotation starts and accelerates to se-


at BLEND MENU press key START lected blend speed

simulate malfunction
of protection components after having switched off
(e.g. fuse, circuit breaker) the motor circuit breaker
5.8.4. caused by over current,
the rotation stops
and
a message bar shows "ALARM"
=> tum off motor circuit breaker (5Q3)

( 5.8.5. switch motor circuit breaker on motor circuit breaker is on

touch message bar "ALARM" menu ALARM becomes visible,


5.8.6.
_t,;..-u-~J fault message is indicated

5.8.7.
press key Q [CONFIRM]
message is confirmed,
key RESET will be enabled, is light grey

5.8.8. press key RESET message is confirmed and cleared

5.8.9. press key EXIT (door symbol) return from menu ALARM
to BLEND MENU

Remarks
SE=tVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

I Date of Version: 122. Dec 2015 I Version: 1

item Description I Start condition Acceptance criteria YES NO

( 5.8.10. press key START sequence is continued

rotation is interrupted, blender is


5.8.11. press key STOP positioning and stops in 0 tum pos.
0

5.8.12. TEST FINISHED

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 32 /
66
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

I Date of Version: 122. Dec 2015 1Version: 1

5.9. HMI-MESSAGE ID NO. 84: TEMPERATURE BLEND MOTOR 1 EXCEED

item Description I Start condition Acceptance criteria YES NO


defined position means:
- arm is at blend height
( check and confirm,
5.9.1. - in 0 turn position
blender is in "blend" position
- inserted container is clamped
- safety door is closed
check and confirm,
user's name "SUPERVISOR"
5.9.2. user is logged in as described
is shown in the head line
in chapter "Access control"
rotation starts and accelerates to se-
5.9.3. at BLEND MENU press key START
lected blend speed

after disconnecting temp. c ontact


simulate a malfunction
the rotation speed
of blend drive motor as a result
slows down to position spe ed,
5.9.4. of increased temperature,
the arm stops at 0 turn position
and
=>disconnect temp. contact (3S3)
a message bar shows "AL ARM"
at terminal X14-14

5.9.5. re-connect temp. contact temp. contact is connected

touch message bar "ALARM" menu ALARM becomes visible,


5.9.6.
r . Jf~ED~J fault message is indicated
5.9.7.
press key D [CONFIRM]
message is confirmed,
key RESET will be enabled, is light grey

5.9.8. press key RESET message is confirmed and cleared

5.9.9. press key EXIT (door symbol) return to BLEND MENU

5.9.10. press key START sequence is continued

rotation is interrupted, blender is


5.9.11. press key STOP positioning and stops in 0 tum pos.
5.9.12. TEST FINISHED

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 33 /
66
SE=iVOLiFT
Operational Qualification (OQ)
type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laboratories SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1Date of Version: 122. Dec 2015 1Version: 1

5.10. HMI-MESSAGE 10 NO. 88: FAILURE FREQUENCY CONVERTER BLEND MOTOR


item Description I Start condition Acceptance criteria YES NO
defined position means:
( check and confirm,
- arm is at blend height
5.10.1.
blender is in "blend" position
- in 0 turn position
- inserted container is clamped
- safety door is closed
check and confirm,
user's name "SUPERVISOR"
5.10.2. user is logged in as described
is shown In the head line
in chapter "Access control"
rotation starts and accelerates to se-
5.10.3. at BLEND MENU press key START lected blend speed
after disconnecting
simulate a malfunction plug from relay 2 at VFD
of frequency converter [VFD] (3U3) the rotation slows down
5.10.4.
by disconnecting plug at relay 2 to position speed,
(check pic input 124.4) the arm stops at 0 turn pos. and
a message bar shows "ALARM"
reconnect plug at VFD 3U3
5.10.5. to relay 2 plug is installed I mounted again
touch message bar "ALARM"
, menu ALARM becomes visible,
5.10.6. L ~ fault message is indicated

message is confirmed,
5.10.7.
press key .ll.J. [CONFIRM] key RESET will be enabled, is light grey

5.10.8. press key RESET message Is confirmed and cleared


return from menu ALARM
5.10.9. press key EXIT (door symbol)
to BLEND MENU

5.10.10. press key START sequence is continued

rotation is interrupted, blender is


5.10.11. press key STOP pOSitioning and stops in 0 tum pos.
5.10.12. TEST FINISHED

Remarks

confirmed I signature confirmed / signature


13565_00_1_ E.docx 34/66
SE=lVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laboratorios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1Date of Version: 122. Dec 2015 1Version: 1

.v.

5.11. HMI-MESSAGE 10 NO. 41: TIMEOUT 0 PROXIMITY SWITCH FLAG


item Description I Start condition Acceptance criteria YES NO
defined position means:

( check and confirm,


- arm is at blend height
5.11.1.
blender is in "blend" position
- in 0 turn position
- inserted container is clamped
- safety door is closed
check and confirm,
user's name "SUPERVISOR"
5.11.2. user is logged in as described
is shown in the head line
in chapter "Access control"
rotation starts and
5.11.3. at BLEND MENU press key START
accelerates to selected blend speed

simulate a malfunction of prox.


after disconnecting prox. switch
switch "turn position 0" (23B2)
5.11.4. by disconnecting the rotation stops after 1 minute and
at terminal X14-4 (=> pic input 0.0) a message bar shows "ALARM"

5.11.5. re-connect prox. switch prox. switch is connected

touch message bar "ALARM" menu ALARM becomes visible,


5.11.6.
r R1J!f\~ fault message is indicated

5.11.7.
press key _ ~
[_J [CONFIRM]
message is confirmed,
key RESET will be enabled, is light grey

5.11.8. press key RESET message is confirmed and cleared

5.11.9. press key EXIT (door symbol) return to BLEND MENU

5.11.10. press key START sequence is continued

rotation is interrupted, blender is


5.11.11. press key STOP positioning and stops in 0 tum pos.
5.11.12. TEST FINISHED

Remarks

confirmed / signature confirmed / Signature


13565_ OQ_1_E.docx 35/66
SE=iVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1Date of Version: 122. Dec 2015 1Version: 1

5.12. HMIMESSAGE 10 NO. 42: FAILURE 0 PROXIMITY SWITCH


item Description I Start condition Acceptance criteria YES NO
defined position means:

check and confirm,


- arm is at blend height
5.12.1.
blender is in "blend" position - in 0 turn position
- inserted container is clamped
- safety door is closed
check and confirm,
user's name "SUPERVISOR"
5.12.2. user is logged in as described
in chapter "Access control" is shown in the head line
rotation starts and
5.12.3. at BLEND MENU press key START accelerates to selected blend speed
rotation is interrupted,
5.12.4. press key STOP positioning starts
simulate a malfunction of prox.
after disconnecting the prox. switch
switch "turn position 0" (23B2)
5.12.5. and during positioning
by disconnecting at terminal X14-5
a message bar shows "ALARM"
(= pic input 0.1) during positioning

5.12.6. re-connect prox. switch prox. switch is connected

touch message bar "ALARM" menu ALARM becomes visible,


5.12.7.
l -~] fault message is indicated

5.12.8. message is confirmed,


press key [[J [CONFIRM] key RESET will be enabled, is light grey

5.12.9. press key RESET message is confirmed and cleared


return from menu ALARM
5.12.10. press key EXIT (door symbol)
to BLEND MENU

5.12.11. press key START sequence is continued and stops at 0

5.12.12. TEST FINISHED

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 36/66
SE=JVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1Date of Version: 122. Dec 2015 1Version: 1

5.13. HMI-MESSAGE 10 NO. 65: CONTAINER NOT IN POSITION


item Description I Start condition Acceptance criteria YES NO
defined position means:

( - arm is at blend height


check and confirm,
5.13.1.
blender is in "blend" position - in 0 turn position
- inserted container is clamped
- safety door is closed
check and confirm,
user's name "SUPERVISOR"
5.13.2. user is logged in as described
is shown in the head line
in chapter "Access control"
rotation starts and
5.13.3. at BLEND MENU press key START
accelerates to selected blend speed

simulate a malfunction of sensor after disconnecting prox. switch


5.13.4. (27B2) "container in position" by the rotation stops at 0 position
disconnecting at terminal X14-20 and a message bar shows "ALARM"

5.13.5. re-connect prox. switch prox. switch is connected

touch message bar "ALARM" menu ALARM becomes visible,


5.13.6.
I ~Ir~ fault message is indicated

message is confirmed,
5.13.7.
press key [[J [CONFIRM] key RESET will be enabled, is light grey

5.13.8. press key RESET message is confirmed and cleared


return from menu ALARM
5.13.9. press key EXIT (door symbol)
to BLEND MENU
5.13.10. press key START sequence is continued

rotation is interrupted, blender Is


5.13.11. press key STOP positioning and stOR_iSn 0 tum pos.
5.13.12. TEST FINISHED

Remarks

confirmed I signature confirmed / signature


13565_OQ_1_E.docx 37/66
SE=1VOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma l.aboratorios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1Version: 1

5.14. HMIMESSAGE ID NO. 66: CONTAINER NOT CLAMPED

item Description I Start condition Acceptance criteria YES NO

defined position means:


( check and confirm,
- arm is at blend height
5.14.1.
~ender~in"b~nd"posmon - in 0 turn position
- inserted container is clamped
- safety door is closed
check and confirm,
user's name "SUPERVISOR"
5.14.2. user is logged in as described
is shown in the head line
in chapter "Access control"
rotation starts and
5.14.3. at BLEND MENU press key START
accelerates to selected blend speed
simulate a malfunction after disconnecting the rotation speed
of pressure switch (27B4) "con- slows down to position speed,
5.14.4.
tainer clamped" by disconnecting the arm stops at 0
at terminal X14-21 (E4.1) and a message bar shows "ALARM"

5.14.5. re-connect pressure / prox. switch pressure / prox. switch is connected

touch message bar "ALARM" menu ALARM becomes visible,


5.14.6.
l r,;~'lr~ fault message is indicated

5.14.7.
press key tJ [CONFIRM] message is confirmed,
key RESET will be enabled, is light grey

5.14.8. press key RESET message Is confirmed and cleared

return from menu ALARM


5.14.9. press key EXIT (door symbol)
to BLEND MENU

5.14.10. press key START sequence is continued

rotation is interrupted, blender is


5.14.11. press key STOP positioning and stops in 0 tum pos.
5.14.12. TEST FINISHED

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 38 /
66
SE=-1VOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1Version: 1

5.15. HMI-MESSAGE ID NO. 74: TIMEOUT AUTO CLAMP (BLENDING/CALIBRATION)

item Description / Start condition Acceptance criteria YES NO


defined position means:
arm is at blend height
( check and confirm,
5.15.1. in 0 turn position
blender is in "blend" position
inserted container is clamped
safet door is closed
rotation starts and
5.15.2. at BLEND MENU press key START
accelerates to selected blend speed
simulate a malfunction / timeout after disconnecting it will be checked
of pressure switch (27B4) "con- if needed clamp pressure is at correct
5.15.3. tainer clamped" during reclamping value after 5 revolutions of the arm,
in case of low pressure by discon- if not
nectin at terminal X14-22 E4.2 a messa e bar shows "ALARM"
5.15.4. re-connect pressure switch pressure switch is connected

touch message bar "ALARM" menu ALARM becomes visible,


5.15.5.
AI AMID. fault message is indicated

5.15.6.
press key 0: [CONFIRM) message is confirmed,
key RESET will be enabled, is light grey

5.15.7. press key RESET message is confirmed and cleared


return from menu ALARM
5.15.8. press key EXIT (door symbol)
to BLEND MENU
5.15.9. press key START

5.15.10. press key STOP

5.15.11. TEST FINISHED

Remarks
SE=lVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1Date of Version: 122. Dec 2015 1Version: 1

5.16. HMIMESSAGE 10 NO. 33: ARM NOT AT BLEND HEIGHT


item Description I Start condition Acceptance criteria YES NO
defined position means:

( check and confirm, - arm is at blend height


5.16.1.
blender is in "blend" position
- in 0 turn position
- inserted container is clamped
- safety door is closed
check and confirm,
user's name "SUPERVISOR"
5.16.2. user is logged in as described
is shown in the head line
in chapter "Access control"
rotation starts and accelerates to se-
5.16.3. at BLEND MENU press key START lected blend speed

after disconnecting the sensor


simulate a malfunction of proximity the rotation stops,
5.16.4. switch (23B11)
by disconnecting
at terminal X14-10 (pic input 0.6) on display at HMI-terminal
a message bar shows "ALARM"

5.16.5. re-connect prox. switch prox. switch is connected

touch message bar "ALARM" menu ALARM becomes visible,


5.16.6.
nv-!R)-CYI fault message is indicated

message is confirmed,
5.16.7.
press key q. [CONFIRM]
key RESET will be enabled. is light
grey
5.16.8. press key RESET message is confirmed and cleared
return from menu ALARM
5.16.9. press key EXIT (door symbol)
to BLEND MENU
5.16.10. press key START sequence is continued

rotation is interrupted, blender is


5.16.11. press key STOP position- ing and stops in 0 tum pos.
5.16.12. TEST FINISHED

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 40/66
J. '.::.: _'; o=

Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

I Date of Version: 122. Dec 2015 I Version: 1

5.17. HMIMESSAGE 10 NO. 49: TIMEOUT SENSOR AT SPROCKET

item Description I Start condition Acceptance criteria YES NO


defined position means:

( check and confirm, - arm is at blend height


5.17.1.
blender is in "blend" position - in 0 turn position
- inserted container is clamped
- safety door is closed
check and confirm,
user's name "SUPERVISOR"
5.17.2. user is logged in as described
is shown in the head line
in chapter "Access control"
rotation starts and accelerates to se-
5.17.3. at BLEND MENU press key START lected blend speed

simulate a malfunction after disconnecting prox. switch


5.17.4. of prox. switch the rotation stops at 0 and
"position of supporting arm" (20B11) a message bar shows "ALARM"
by disconnecting at terminal X14-3
5.17.5. re-connect prox. switch prox. switch is connected
touch message bar "ALARM" menu ALARM becomes visible,
5.17.6.
r '.!!I_~;~~ fault message is indicated
message is confirmed,
5.17.7.
press key [J [CONFIRM] key RESET will be enabled, is light grey

5.17.8. press key RESET message is confirmed and cleared

5.17.9. press key EXIT (door symbol) return to BLEND MENU

5.17.10. press key START sequence is continued

rotation is Interrupted, blender is


5.17.11. press key STOP positioning and stops in 0 tum pos.
displayed BLEND MENU is closed,
5.17.12. press key EXIT (door symbol) OPERATOR MENU is indicated again
5.17.13. press key EXIT (door symbol) again MAIN MENU is indicated again

5.17.14. TEST FINISHED

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 41/66
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122.Dec 2015 1 Version: 1

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 42/66
SE=tVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratorlos SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

I Date of Version: 122. Dec 2015 1 Version: 1

5.18. HMIMESSAGE ID NO. 50: FAILURE MAINS CONTACTOR HYDRAULIC PUMP

item Description I Start condition Acceptance criteria YES NO


defined position means:
(
- arm is at blend height
5.18.1. check and confirm, - in 0 turn position
blender is in "blend" position
- inserted container is clamped
- safety door is closed
menu is opened,
5.18.2. press key OPERATOR MENU
submenus become visible
5.18.3. press key MANUAL MODE menu with manual functions is opened
simulate a fault of power circuit
power circuit breaker of hydraulic
5.18.4. breaker of hydraulic pump pump 5K11 is disconnected
by disconnecting 5K11 at pin 22
function does not start,
5.18.5. press and hold key UNCLAMP a message bar shows "ALARM"
outside on HMI-terminal
re- connect power circuit breaker connection is done, 5K11-22 is connected
5.18.6. of hydraulic pump => 5K11 at pin 22 to pic input 126.4 (as before)
touch message bar "ALARM" menu ALARM becomes visible,
5.18.7.
l ~r;;:u'!1 1l1~1 fault message is indicated
message is confirmed,
( 5.18.8. key RESET will be enabled, is light
press key ~ [CONFIRM] grey
5.18.9. press key RESET message is confirmed and cleared
return
5.18.10. press key EXIT (door symbol) from menu ALARMS to MANUAL
MODE
user continues sequence, unclamping
5.18.11. press and hold key UNCLAMP starts again
and stops at min height position
clamping starts,
5.18.12. press and hold key CLAMP
it stops when container is clamped

5.18.13. TEST FINISHED

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 43 /
66
SE=lVOLiFT
:,: .. :;.-< ~':: ; <u: 1]<.

Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1Date of Version: 122. Dec 2015 1Version: 1

6. Bring container back to min height


this test is used to show how container can be brought back to defined start position by using available
manual function keys. If machine is back in start position it is ready for next blend sequence.
6.1. Procedure as follows (1600L container)
item Description I Start condition Acceptance criteria YES NO
defined position means:

check and confirm,


- arm is at blend height
6.1.1. blender is in "blend" position -in 0 turn position
-inserted container is clamped
- safety door is closed
unclamping starts,
6.1.2. press and hold key UNCLAMP
inserted container is unclamped
arm is lowered
6.1.3. press and hold key LOWER
to pick-up height 1600L
go into blend room, position hand
container is removed
6.1.4. paliet truck and
remove container by hand pallet truck, arm is free
close safety door and go to HMI
6.1.5. panel safety door is closed
at HMI panel:
safety module is switched on,
6.1.6. press key (blue, blinking)
sequence can be continued
ACTIVATE SAFETY CIRCUIT
lowering starts
6.1.7. press and hold key LOWER again
and stops at min. height

6.1.8. TEST FINISHED

Remarks
SE=lVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laboratorios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1 Version: 1

7. Functional Sequence(s)
At this section the "normal" operational sequences is checked. Possible sequences is Blending with all
lnterlocks activated, and Maintenance for setting up the machine without interlocks.

7.1. Blending (with 1600L container)


(
item Description I Start condition Acceptance criteria YES NO
defined position means:

7.1.1.
check and confirm, - arm is at min. height
blender is in "defined" position - in 0 turn position
- container type 1600L is available
check and confirm,
user's name "SUPERVISOR"
7.1.2. user is logged in as described
in chapter "Access control" is shown in the head line
go to HMI terminal and screen changes and
7.1.3. submenus will be displayed
press key OPERATOR MENU
7.1.4. press key MANUAL MODE menu MANUAL MODE is displayed
press key (blue, blinking) safety module is switched on,
7.1.5.
ACTIVATE SAFETY CIRCUIT sequence can be continued
lifting starts and
7.1.6. press and hold key LIFT
stops at pick UP heloht bia container
go into blend room, insert availa-
7.1.7. ble container container is in position
( into supporting arm
remove hand pallet truck, leave hand pallet truck is removed, safety
7.1.8.
blend room and close safety door door is closed
at HMI panel:
safety module is switched on,
7.1.9. press key
sequence can be continued
ACTIVATE SAFETY CIRCUIT
press and hold key LIFT until
lifting starts
7.1.10. max. height (=blend height) is
and stops at max. height
reached
7.1.11. press and hold key CLAMP inserted container will be clamped

MANUAL MODE is closed,


7.1.12. press key EXIT (door symbol) OPERA TOR MENU is disolaved

Remarks
5E~VOLiFT ,l '.' :." ~ .' ',_ ',.

Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Customer: Eurofarma Laborat6rios SA, Itapevi - Customer Reference 4500233630


Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

item Description I Start condition Acceptance criteria YES NO


at OPERATOR MENU menu is loaded, dataset can be selected
7.1.13. press key PARAMETER MENU by pressing key with arrow down
to select blend parameter at input line "RECIPE"
if confirmation was successful, corre-
sponding blend data are displayed,
RECIPE
fsAMPLE RECIPE i _..'..-. ... ~- - - - _.

Uatft recont re~d


press key with arrow down
and select "SAMPLE RECIPE1" J"InOOuCT NAME. fJ\~~'~"'"
PRODUCT NUNSER, rI23~S' ..

STEP I

7.1.14. RECIPE BLEND nNE (NIN) I,'


BLIND RE\lERSE TIME (MIN) I~-. -
BlEND SPEED 1;--' --
1-"'f':"';'1:.I1II~~4:["~:.I~ (RPN)

ISAMPL~ tft-L.\I'I: 2 PRooucr lEvnUNG (NS) I,;;""


BATCH:
l
only input of BATCH is possible
and required (shown by yellow input
line if configured previously in menu
SYSTEM SETTINGS)
7.1.15. touch into input box for BATCH screen keyboard is displayed
put in value
7.1.16. "13565-BLEND-TEST" value is entered and confirmed
and confirm it by ENTER key
PARAMETER MENU is closed,
7.1.17. press key EXIT (door symbol) OPERATOR MENU is displayed aqaln
blend menu is opened,
7.1.18. press key BLEND MENU
entered blend data are shown
rotation starts and blend speed
7.1.19. press key START accelerates to preset blend speed,
here as selected up to 8 rpm
confirm, during running blend cycle current state of blend time and blend
7.1.20. current state of values is displayed speed are displayed by bar graphs

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 46 /
66
SE=iVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender J Servo lift Project No. I 13565

Eurofarma Laboratorlos SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1Version: 1

item Description I Start condition Acceptance criteria YES NO


after blend time is elapsed the blend
speed decelerates to positioning speed
and arm stops approx. 30-deg after verti-
7.1.21. blend time is elapsed cal position to compensate product's an-
gie of repose, afterwards arm is rotated
back and stops at 0 turn position,
means blend cycle is finished
blend cycle - is now finished, BLEND MENU is closed,
7.1.22.
press key EXIT (door symbol) OPERA TOR MENU is displayed
7.1.23. press key MANUAL MODE menu MANUAL MODE is displayed

7.1.24. press and hold key UNCLAMP container in arm is unclamped

7.1.25. press and hold key LOWER arm is lowered to pick-up height 1600L
go into blend room, position hand
container is removed from arm,
7.1.26. pallet truck under the container in
arm is free
arm and remove it
close safety door and go to HMI
7.1.27. safety door is closed
panel
at HMI panel:
safety module is switched on,
7.1.28. press key (blue, blinking)
sequence can be continued
ACTIVATE SAFETY CIRCUIT
7.1.29. press and hold key LOWER again lowering starts and stops at min. height

7.1.30. TEST FINISHED

Remarks

confirmed / signature confirmed / signature


13565_ OQ_1_E.docx 47166
/ ') I ~'.. '. _. #-,
,I ", _'.; .. . .",." ".

Operational Qualification (OQ)


Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1 Version: 1

7.2. Maintenance mode I sequence


this menu is used and includes functions only for adjustments and maintenance purposes or in case of
malfunction of the Container Blender to bring the machine back in a defined "start" position.
User needs at least MAINTENANCE authorization or on higher levels ADMINISTRATION authorization.
All functions are active as long as the corresponding key is pressed .

Within this menu I this mode


the machine can be operated without any interlocks.
Be, careful! by starting any movement,
.~ especially lifting/lowering or rotational functions.
ATTENTION

item Description I Start condition Acceptance criteria YES NO


check and confirm, user is logged in
as described user's name "MAINTENANCE"
7.2.1. in chapter "Access control", is indicated in the head line
change it to "MAINTENANCE"
submenus become visible:
- MAINTENANCE MODE
- CALI BRATION MENU
- MAINTENANCE SETIINGS

( 7.2.2.
starting from MAIN MENU - SERVICE INTERVAL
press key MAINTENANCE MENU - STATE INDICATION

BY SYMBOL 6d
- ARCHIVE ALARMS

BYSYMBOL~
menu is shown with flashing warning
7.2.3. press key MAINTENANCE MODE and available manual functions
for setting-up the machine
... continued on next page

Remarks

confirmed / signature confirmed I signature


13565_OQ_1_E.docx 48/66
SE=lVOLiFT
i .. '
, , ,. .. ; - ,-:':':;. t,; ..-,

Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratorlos SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us orner e erence

1 Date of Version: 122. Dec 2015 1 Version: 1

item Description I Start condition Acceptance criteria YES NO


with pressed and hold a key
the related function can be carried
out
check and confirm, without regarding current position!
with each pressed function key
any movement starts:
with pressed key LIFT arm is lifted
7.2.4. e.g.
if pressed and hold key LIFT and stops at max height
and
if pressed key TURN LEFT
then pressed TURN LEFT
manual rotation would be possible
without
being at correct height position!
if working in maintenance mode
is finished
return the machine back machine is back in start position
if following conditions are fulfilled:
to it's defined start position
7.2.5. - arm is at min. height
by using displayed functions,
- and in 0 turn position
0

the machine can then be operated


- and clamp system unclarnped

in "normal" manual mode again


MAINTENANCE MODE is closed,
7.2.6. press key EXIT (door symbol) MAINTENANCE MENU is shown
( 7.2.7. press key EXIT again MAIN MENU is displayed again

in case of testing several functions


in MAINTENANCE MODE menu
several alarm message( s)
have occurred,
which have to be with touched message bar
7.2.8. menu ALARM becomes visible,
acknowledged and reset fault message is indicated
to enable operating in "normal"
mode:
touch message bar "ALARM"
and call separate menu
message is confirmed,
7.2.9.
press key Q [CONFIRM] key RESET will be enabled

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 49/66
~i; ,.. -~.. ~..'.. W' ~.!~~

Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1 Date of Version: 122. Dec 2015 1 Version: 1

item Description I Start condition Acceptance criteria YES NO

all messages
7.2.10. press key RESET
are confirmed and cleared
7.2.11. press key EXIT (door symbol) return to MAIN MENU

7.2.12. TEST FINISHED

Remarks

confirmed / signature confirmed / signature


13565_ OQ_1_E.docx 50/66
SE=1VOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratorlos SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1 Version: 1

h. Adjustments
Following sections are used to check how the user can execute modifications of machine set points
and to edit or modify user identifications.

it contains following tests to check the functionality as it is given in the contract:


~ test procedure of recipe management
- test procedure of password management
- test procedure of printer settings
- test procedure of terminate running application and restart

Remarks

confirmed / signature confirmed I signature


13565 _ OQ_1_E.docx 51/66
SE~VOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma l.aboratorlos SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1 Date of Version: 122. Dec 2015 1 Version: 1

8.1. SUPERVISOR MENU - RECIPE MANAGEMENT


this menu is used to show and to check the procedure for creation of new recipe data sets, how to modify
single data of previously called recipe data sets or to delete existing ones.

For access to functions of this menu user needs authorization for SUPERVISOR or ADMINISTRATOR
(
ieve!. The call of this menu is independent of current machine position, but it is recommended it should
be in defined start position.

item Description I Start condition Acceptance criteria YES NO


defined I start position means:

8.1.1. check and confirm, - arm is at min. height


blender is in "defined" position - in 0 turn position
- with clamp system unclamped
check and confirm,
user is logged in as described user's name "SUPERVISOR"
8.1.2. in chapter "Access control", is indicated in the head line
chance it to "SUPERVISOR"
submenus are indicated:
starting from MAIN MENU
8.1.3.
press key SUPERVISOR MENU
- RECIPE MANAGEMENT
- SYSTEM SETIINGS
recipe management is shown,
8.1.4. press key RECIPE MANAGEMENT function keys become visible
8.1.5. to create new recipe dataset...

8.1.6. cursor blinks at input box RECIPE


press key NEW I :::i. I
.i
touch input box and enter
new recipe name I data set name recipe data set name
8.1.7.
"TEST-1", use screen keyboard, is entered and confirmed
and confirm input by ENTER key
now put in each parameter:
product name
8.1.8. start with PRODUCT NAME
is entered and confirmed,
put in "NEW-RECIPE-13565" it contains maximum 40 characters
and confirm input by ENTER key
... continued on next page

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 52 /
66
SE=tVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Pau I0, '1 us omer e erence 4500233630
B razt

I Date of Version: 122. Dec 2015 1Version: 1

item Description I Start condition Acceptance criteria YES NO

product number
move to PRODUCT NUMBER, is entered and confirmed,
8.1.9.
put in "13565001", it contains maximum 40 characters
( confirm input by ENTER key

touch input box


BLEND TIME and blend time is entered and confirmed,
8.1.10.
change displayed value to 25 min, value is within range 1 to 99 [minutes]
confirm input by ENTER key on dis-
played screen keyboard

select input box reverse time (change direction)


8.1.11. BLEND REVERSE TIME, is entered and confirmed.
change value to 5 min, value is within range 0 to 99 [minutes]
confirm input by ENTER key

move to BLEND SPEED,


blend speed is entered and confirmed
8.1.12. change value to 10 rpm,
value is within range 5 to 15 [rpm]
confirm input by ENTER key

now all parameter entered, levelling value is entered and con-


move to box LEVELLING, firmed,
8.1.13.
change value to 2500 ms, value is within range 0 to 5000
( confirm Input by ENTER key [millisecond]

if inputs are finished,


new recipe dataset is saved,
and to store all inputs
8.1.14. advice message is displayed
below input box DATASET
press key SAVE 11'::11
RECIPE MANAGEMENT is closed,
8.1.15. press key EXIT (door symbol) SUPERVISOR MENU is shown
menu is closed,
8.1.16. press key EXIT(door symbol)again MAIN MENU is displayed

... continued on next page

Remarks
SE=tVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1Version: 1

item Description I Start condition Acceptance criteria YES NO


call new recipe
8.1.17.
in PARAMETER MENU ...
confirm, at HMI-terminal
( the MAIN MENU is displayed
user's name "SUPERVISOR"
8.1.18. and
user is logged in as described is indicated in the head line
in chapter "Access control"
screen changes,
8.1.19. press key OPERATOR MENU
submenus become visible
menu is displayed,
8.1.20. press key PARAMETER MENU
function keys become visible
new recipe dataset called TEST-1
press key with arrow down
8.1.21. and try to select can be selected,
recipe dataset TEST-1 from list corresponding blend data are shown,
input of batch number is required
touch input box BATCH,
screen keyboard is displayed, BATCH number
8.1.22. is confirmed and displayed
enter BATCH number "4711",
confirm input by ENTER
close menu by pressing PARAMETER MENU is closed,
8.1.23. key EXIT (door symbol) OPERATOR MENU is shown again
.8.1.24. press key EXIT (doorsymbol)again MAIN MENU is displayed again

( 8.1.25. to modify recipe dataset ...


submenus are indicated:
starting from MAIN MENU
8.1.26.
press key SUPERVISOR MENU
- RECIPE MANAGEMENT
- SYSTEM SETTINGS
recipe management is shown,
8.1.27. press key RECIPE MANAGEMENT
function keys become visible
at line DATASET
8.1.28.
press key with arrow down GI list with available recipes is shown

recipe is selected,
8.1.29. select recipe "TEST-1" from list
blend data loaded and displayed

Remarks
Eurofarma Laboratories SA, Itapevi - C t R f 4500233630
Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1Version: 1

item Description I Start condition Acceptance criteria YES NO


changes are possible
in all parameter, as example
change blend time
( screen keyboard is displayed as soon
8.1.30.
as entry field is touched
=> touch input box BLEND TIME
and change value to 45 min,
use displayed screen keyboard,
value of BLEND TIME
8.1.31. confirm each value by ENTER key is modified and confirmed,
new value is displayed
to store modification a message will be displayed:
8.1.32. I
"Data record saved"
press key SAVE and modified parameter are saved
the changed parameter of recipe data
confirm, modified parameter set "TEST-1" are stored, a system mes-
8.1.33. are saved and displayed sage shows if action was successful

RECIPE MANAGEMENT is closed,


8.1.34. press key EXIT (door symbol) SUPERVISOR MENU is shown
8.1.35. press key EXIT (door symbol)again MAIN MENU is displayed again

. 8.1.36. to delete recipe dataset ...


confirm, at HMI-terminal
the MAIN MENU is displayed user's name "SUPERVISOR"
8.1.37. and user is logged in as described is indicated in the head line
in chapter "Access control"
submenus are indicated:
starting from MAIN MENU
8.1.38.
press key SUPERVISOR MENU
- RECIPE MANAGEMENT
- SYSTEM SETIINGS
8.1.39. press key REaPE MANAGEMENT menu is opened
at line DATASET
8.1.40. list with available recipes is shown
press key with arrow down 1 :..] 1
recipe is selected,
8.1.41. select recipe "TEST-1" from list
blend data loaded and displayed

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 55/66
SE=lVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma l.aboratorlos SA, Itapevi - Customer Reference 4500233630


Customer:
Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

item Description I Start condition Acceptance criteria YES NO


a query- dialogue will be displayed:
"Do you really want to delete
data record "TEST-1"

( 8.1.42.
press key DELETE
IX I which must be implicitly confirmed
in recipe BLEND DATA?"
to avoid unintended deletion

selected recipe "TEST-1" is deleted,


8.1.43. press key YES a message will be displayed
confirm, if pressed key
recipe list is opened and recipe called
8.1.44. with arrow down
"TEST-1" is not displayed,
to open recipe list recipe means deletion was successful
it is not displayed ...

RECIPE MANAGEMENT is closed,


8.1.45. press key EXIT (door symbol)
SUPERVISOR MENU is shown

8.1.46. press key EXIT again MAIN MENU is displayed

8.1.47. TEST FINISHED

Remarks

confirmed / signature confirmed I signature


13565_OQ_1_E.docx 56/66
SE=iVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Customer: Eurofarma Laboratories SA, Itapevi - C t R f


Sao Paulo, Brazil us omer e erence 4500233630

1Date of Version: 122. Dec 2015 1Version: 1

8.2. ADMINISTRATOR MENU - PASSWORD I USER MANAGEMENT


this menu is used to show and to check the procedure for creation of new users, how to modify single
data (e.g. assignment of user rights) or to delete existing user datasets completely. For access
to functions of this menu user needs authorization for ADMINISTRATOR level.
the call of this menu is independent of current machine position, but it is recommended that it should be
In defined start position.
Following tests will be done:
to create new user identification ,
to check to login with new created user identification
to change single parameter of existing user identification, e.g. assigned user group
to delete existing user identification completely
to check to login with deleted or wrong user identification

item Description I Start condition Acceptance criteria YES NO


defined J start position means:

check and confirm, - arm is at min. height

--
8.2.1. blender is in "defined" position in 0 turn position
with clamp system unclamped
check and confirm, user is logged in
user's name "ADMIN1"
8.2.2. as described in chapter "Access
is indicated in the head line
control", change it to "ADMIN1"
( ADMINISTRATOR MENU is opened,
starting from MAIN MENU
8.2.3. function keys and available submenus
press key ADMIN. MENU
become visible
menu USER MANAGEMENT
8.2.4.
press key:::;' is displayed showing user overview list

8.2.5. to create new user identification ...


select J move to first column
8.2.6. called "User" and make a click in screen keyboard is displayed
last blank line
... continued on next page

Remarks

confirmed J signature confirmed I signature


13565_OQ_1_E.docx 57/66
SE=tVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

I Date of Version: 122. Dec 2015 1Version: 1

item Description I Start condition Acceptance criteria YES NO


input is possible
user name "JOHN PUBLIC"
put in is entered,
( user name "JOHN PUBLIC" confirmed and displayed
and confirm input by ENTER key

NOTE! decide between capital


8.2.7. "A... " or small letters "a ... ",
for capital letters only use key
CAPS-LOCK at screen keyboard
-'- .... ~,
.0- CAPS-LOCK
:+-
SHIFT
---
11 j_f +-

move to column "Password"


and screen keyboard and new dialog
8.2.8. make a click into "Change password" are displayed
corresponding blank input box
select at dialog
"Change password" "NEW password"
the input box "NEW password" is entered and confirmed
and enter "NEW-USER1"
8.2.9.
( note: do not use following charac-
ters for passwords: blank or spe-
cial characters
r. ?, _, %, /, I, " '~
move to input box "NEW password"
8.2.10. "Confirmation" and repeat input is repeated and confirmed
dialog
8.2.11. press OK
"Change password" is closed
... continued on next page

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 58 /
66
SE=iVOLiFT
""it;;:",. :,'.:' ..

Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1 Date of Version: 122. Dec 2015 1 Version: 1

item Description I Start condition Acceptance criteria YES NO


NOTE! after confirmation
of entered user password user called "JOHN PUBLIC"
the user is sorted in order is sorted in to overview list
8.2.12.
( alphabetical
into the user overview, (direct before
the position depends on user called "MAINTENANCE")
the initial letter of the user name
to change status "Unauthorized"
at column "Group" key with arrow down is indicated
8.2.13. to open a list
make a click into input box "Unauthor-
box ized"

predefined user groups are shown:


- ADMINISTRATOR
8.2.14.
press key with arrow down G - MAINTENANCE
- SUPERVISOR
- USER
- Unauthorized

list box is closed, group "USER"


8.2.15. select entry "USER" is assigned and indicated

to change automatic logoff time


move to last column "Logoff time"
8.2.16. and make screen keyboard is displayed
a click to activate the field

click again into input box,


8.2.17. modify time from "5" to "30" min, automatic logoff time was set
confirm input b_yE_NTER key
new created user is assigned
8.2.18. confirm, after modification new user to group USER
"JOHN PUBLIC" is created
with automatic logoff time 30 min
menu
8.2.19. press key EXIT (door symbol) USER MANAGEMENT is closed,
ADMINISTRATOR MENU is shown
8.2.20. press key EXIT again MAIN MENU is displayed

,.. continued on next page

Remarks
SE=lVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender J Servolift Project No. I 13565

Eurofarma Laboratories SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1Date of Version: 122. Dec 2015 I Version: 1

item Description I Start condition Acceptance criteria I YES NO

8.2.21. to check to login with new created user identification ...


-
(
8.2.22.
press key LOGIN L
t user LOG ON dialogue
and screen keyboard are displayed
touch input box "USER" and
put in user name "JOHN PUBLIC"
8.2.23. user name "JOHN PUBLIC", is entered and confirmed
confirm input by ENTER key
move
to input box "PASSWORD"
user password
and put in
8.2.24. is entered and confirmed,
user password "NEW-USER1 ",
confirm input by ENTER key but its not readable, its hidden

after successful login


8.2.25. close dialogue with key OK user name "JOHN PUBLIC"
is displayed at head line

8.2.26. press key ADMIN. MENU ADMINISTRATOR MENU is opened


login of new user was registered:
confirm, in overview IN. AOMIHlflllAlOM M[NV

8.2.27. )()tINI'lH'tIC

,...
'''"
HQ.I fl'"

the login procedure was noted

8.2.28. press key LOGOFF Y


displayed in the head line
user "JOHN PUBLIC" is logged out,
and currently no user is logged in
ADMINISTRATOR MENU is closed,
8.2.29. press key EXIT (door symbol) MAIN MENU is displayed again

after successful input user's name


press key LOGIN and put in "ADMIN1" is indicated at head line
8.2.30. user identification of "ADMIN1"

Remarks

confirmed / signature confirmed / signature


13565_OQ_1_E.docx 60/66
SE=JVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1Date of Version: 122. Dec 2015 1Version: 1

item Description I Start condition Acceptance criteria YES NO

.8.2.31. to change single parameter of new user identification and check if it works
in ADMINISTRATOR MENU
(. menu USER MANAGEMENT is dis-
( 8.2.32.
press key i:,l played showing user overview list

select user "JOHN PUBLIC",


and
actual value is selected,
modify assignment to user group,
8.2.33. at the moment
user is assianeo to "USER" group
=> make a click to activate field 3rd
column "GROUP"
now user is assigned
change displayed value from
8.2.34. to group "SUPERVISOR" which enables
"USER" to "SUPERVISOR"
access to more functions
USER MANAGEMENT is closed,
8.2.35. press key EXIT (door symbol) ADMINISTRATOR MENU
is displayed again
8.2.36. press key EXIT again MAIN MENU is displayed again
~.
press key LOGIN I
user LOG ON dialogue
8.2.37.
and and screen keyboard are displayed
log in as "JOHN PUBLIC" again
put in necessary "USER" name
( after successful login
8.2.38. and "PASSWORD",
user name "JOHN PUBLIC"
(password: NEW-USER1) is displayed at head line again
close dialogue with key OK
8.2.39. to delete user identification

8.2.40. press key ADMIN. MENU ADMINISTRATOR MENU is opened


press key LOGIN and put in after successful input user's name
8.2.41.
user identification of "ADMIN1" "ADMIN1" is indicated at head line
~,
, menu is opened
8.2.42. press key in displayed showing user overview list
ADMINISTRATOR MENU
... continued on next page

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 61/66
SE=tVOLiFT
Operational Qualification (OQ)
Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1Date of Version: 122. Dec 2015 1Version: 1

item Description I Start condition Acceptance criteria YES NO

select user "JOHN PUBLIC",


user name is selected,
8.2.43. make a click onto its name at first
screen keyboard is indicated
( column "User"

activate input box user name will be highlighted


8.2.44. by a second click and may be modified

delete user name completely,


after confirmation
using jCkspace ~ key
the screen keyboard will be closed and
8.2.45. Del
or (DELETE) key user name "JOHN PUBLIC"
on screen keyboard and confirm is deleted from member list
modification by ENTER key

USER MANAGEMENT is closed,


8.2.46. press key EXIT (door symbol) ADMINISTRATOR MENU is shown
8.2.47. to check to login with deleted or wrong user identification

( 8.2.48.
. user Log on dialogue
press key LOGIN and screen keyboard are displayed

touch box "USER" and put in user


user name "JOHN PUBLIC"
8.2.49. name "JOHN PUBLIC",
confirm input by ENTER key is entered and confirmed

move to box "PASSWORD"


and put in user password
8.2.50.
user password "NEW-USER1 ", is entered and confirmed
confirm input by ENTER key

... continued on next page

Remarks

confirmed / Signature confirmed / signature


13565_OQ_1_E.docx 62/6
6
SE=lVOLiFT
'1~.C' i": :.;; .... L ".

Operational Qualification (OQ)

Type of Machine: I Container Blender J Servo lift Project No. I 13565

Eurofarma Laborat6rlos SA, Itapevl - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1Date of Version: 122. Dec 2015 1Version: 1

item Description I Start condition Acceptance criteria YES NO

with pressed key OK


a message appears which indicates
( that user identification is invalid
[~fm. SE=iVOLiFT
8.2.51. close dialogue with key Ok USER ADMINISTRATOR MENU

2"6(fI'tOQ ilh'lIlld J):J!.twOrd 0 .. ut6r neme. logOn nas htllfd.

this means, user "JOHN PUBLIC" was


deleted successfully from list

press key LOGIN and put in after successful input user's name
8.2.52. user identification of IADMIN1" IADMIN1" is indicated at head line

8.2.53, press key EXIT (door symbol) MAIN MENU is displayed again

8.2.54. TEST FINISHED

Remarks

confirmed I signature confirmed I signature


13565_OQ_1_E.docx 63 /
66
SE=iVOLiFT
:,;;,,~u::,"'': >,.:. ,',q;,

Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. J 13565

Eurofarma Laborat6rios SA, Itapevi - C t R f


Customer: Sao Paulo, Brazil us omer e erence 4500233630

1 Date of Version: 122. Dec 2015 1 Version: 1

8.3. TERMINATE I SHUTDOWN RUNNING APPLICATION


Call ADMINISTRATOR MENU and use this function for closing of running application. Then calling of
operating system Windows CE will be possible which gives access to system loader menu
for configuration of HMI-terminall operator panel special functions. For access user needs authorization
( to ADMINISTRATOR level.

item Description I Start condition Acceptance criteria YES NO

confirm, at HMI-terminal MAIN MENU with selectable


8.3.1. the MAIN MENU is displayed sub menus is displayed
check and confirm, user is logged in
after successful input
8.3.2. for SUPERVISOR level,
user's name "SUPERVISOR"
if not press key LOGIN and is shown in the head line
put in valid user identification
after successful input
change current user to "ADMIN1"
8.3.3. user's name "ADMIN1"
by pressed key LOGIN
is shown in the head line
8.3.4. press key ADMIN MENU submenus become visible
the running application is closed,
desktop of operating system
8.3.5. press key TERMINATE 0 -- and
dialogue "LOADER" are shown
with pressed key START
( in loader menu
to continue and restart application the application starts again,
8.3.6. press key START
at displayed dialog "LOADER"
after initialization PORTUGUESE
as operating language is active
after having pressed
press key with national flag key with national flag
8.3.7. to change operating language of HMI all tests and menu names changes,
to ENGLISH MAIN MENU is shown,
and no user is logged in again
8.3.8. TEST FINISHED

Remarks
SE=JVOLiFT ~ . ..
)
.,

Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma t.aboratortos SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1 Date of Version: 122. Dec 2015 1 Version: 1

9. List of Deviations I repair work


All defects, which are detected during OQ tests, are listed below together with the necessary actions
to eliminate the defects.

No. Test No. Defect Measure to eliminate Responsibility


(

13565_OQ_1_E.docx 65 /
66
SE=iVOLiFT
Operational Qualification (OQ)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma taboratorlos SA, Itapevi - C t R f 4500233630


Customer: Sao Paulo, Brazil us omer e erence

1 Date of Version: 122. Dec 2015 1 Version: 1

10. Final Statement

D The equipment meets the requirements made in the purchase contract.


No defects found out.
The OQ is successfully finished.
(

D The equipment meets the requirements made in the purchase contract.


Please consider the comments: Defects were found and have to be eliminated.
The OQ is successfully finished, when the defects are eliminated until _

( name/ signature position date

reviewed by:
Sig:

reviewed by:
Sig:

approved by:
Sig:

- END of document-

13565_OQ_1_E.docx 66 /
66
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratorios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

SOFTWARE DESIGN SPECIFICATION


of
(
Container - Blender

Eurofarma Laboratorios S.A.,


Itapevi - Sao Paulo,
Brazil

Supplier Name / Signature Position Date

,,-;tp
Mr. R. ~hri.n$;ler/ ,
Electrical
Written by:
Sig:
~ /I. <proqrarnrninq dept.
23. Dec. 2015

Ms. M''f1ttkPo~ Electrical


Reviewed by: 23. Dec. 2015
Sig: . t 0 ~f... editorial dept.

Mr. C. ,(arms Asst. manager


./
Approved by: . i' ..i,.../t-t/"'\ 23. Dec. 2015
Sig: / \... electrical dept.

Customer Name / Signature Position Date

Reviewed by:
Sig:

Reviewed by:
Sig:

Approved by:
Sig:

13565_SDS_1_E.docx 1/
58
SE=iVOLiFT
'.. . ". ~:1'"

Software Design Specification (SDS)


Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

! Date of Version: !23. Dec 2015 ! Version: 1

Version control - Change history - Change control

this page will be revised each time the specification is revised and re-issued, to record the dates and
reason for issue. All changes of this document (either for review or approval) are registered in this list.

(
Change Date Editor Reason for Change

1 23. Dec 2015 BR initial version

13565_SDS_1_E.docx 2/
58
SE=JVOLiFT
Software Design Specification (50S)

Type of Machine: I Container Blender 1 Servo lift Project No. I 13565

Eurofarma l.aboratorlos SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1 Version: 1

Table of Contents

1. Introduction 6
1.1. Author/Authority 6
1.2. Objective of document 6
1.3. Contractual Status 6
1.4. Reference Docu ment( s) 6

2. Overview 7
2.1. Program Development 7
2.1.1. PLC development 7
2.1.2. HMI Development 7
2.1.3. Software development list. 7
2.2. Version Control 8
2.2.1. PLC version 8
2.2.2. HMI version 8
2.3. HMI and PLC Interface Design 9

3. System Description 10
3.1. PLC 10
( 3.1.1. Siemens S7 PLC Program Structure 10
3.1.2. Program Description 10
3.1.3. Symbolic Conventions 10
3.1.4. Program Block Specification Descriptions 11
3.1.4.1. Siemens S7 - OB _ Organisation Blocks 11
3.1.4.2. Siemens S7 - Fe _ Functions 11
:t 1.4.3. Siemens S7 - FB _ Function Blocks 12
3.1.4.4. Siemens S7 - DB _ Data Blocks 12
3.1.5. Siemens S7 PLC Program Blocks Listing 13
3.2. HMI 15
3.2.1. HMI Access Security 15
3.2.1.1. User Groups and Authorizations 15
3.2.1.2. Assignment of functions to user groups 16
3.2.1.3. Users and Passwords 18
3.2.1.4. Logoff Times 18
3.2.1.5. Backup and Restore 18
3.2.1.6. Limits of users and passwords 18
3.2.1.7. Extended security and access control requirements, deviations from SL standard 18

13565_SDS_1_E.docx 3/
58
SE=iVOLiFT
/":> :;'!!'.,,; ';.n: : ~

Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

i Date of Version: 123. Dec 2015 1Version: 1

3.2.2. General Screen Layout of HMI menus 19


3.2.3. Operating / Terminal Language 21
3.2.4. Screen overview / Menu navigation 22
3.2.5. Detailed Screen Description 23
3.2.5.1. Main menu , 23
3.2.5.2. Operator menu 24
3.2.5.3. Maintenance menu 25
3.2.5.4. Supervisor menu 26
3.2.5.5. Administrator menu 27
3.2.5.6. Manual mode menu 28
3.2.5.7. Parameter menu 29
3.2.5.8. Test recipe menu 30
3.2.5.9. Blend menu 31
3.2.5.10. Batch Archive 32
3.2.5.11. Archive Index 33
3.2.5.12. Maintenance mode menu 34
3.2.5.13. Calibration menu 35
3.2.5.14. Maintenance settings 36
3.2.5.15. Service Interval 37
3.2.5.16. State Indication 38
3.2.5.17. Alarm Archives 39
( 3.2.5.18. Recipe Management 40
3.2.5.19. System settings 41
3.2.5.20. User Management 42
3.2.5.21. Alarms 43

4. System data 44
4.1. System/ Machine Parameter 44
4.1.1. 0 proxim ity switch settings 44
4.1.2. batch entry setting 45
4.1.3. system settings, general 46
4.1.4. printer settings 47
4.1.5. customer specific machine definition 47
4.1.6. Message Handling 48
4.1.6.1. Alarm messages 48
4.2. Communication to extern systems 49
4.3. Recipe data 49
4.4. Recorded data 50
"

4.4.1. Example for batch report protocol. 51

13565_SDS_1_E.docx 4/
58
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 I Version: 1

5. PLC Module Description 52


5.1. OB functional description 53
5.1.1. OB1 (STANDARD MAIN OB) - MAIN PROGRAM 53
5.1.2. OB100 - PLC FIRST CYCLE 53
(
5.2. FB functional description 53
5.2.1. FB11 - CLAMP 53
5.2.2. FB12 - LIFT 53
5.2.3. FB16 - TURN 53
5.2.4. FB60 - AUTO CLAMP " , 53
5.2.5. FB64 - FNCT BLEND 53
5.2.6. FB65 - REVERSE TIME EVALUATION 53
5.2.7. FB69 - BLEND TIME EVALUATION 53
5.2.8. FB81 - WORKING HOURS 54
5.2.9. FB85 - FNCT SPEED CALIBRATION 54
5.2.10. FB87 - SPEED CORRECTION 54
5.2.11. FB90 - SERVICE INTERVAL 54
5.2.12. FB92 - ADVICE MESSAGES 54
5.2.13. FB97 - ACTUAL SPEED CORRECTION 54
5.2.14. FB99 - DISTURBANCE MANAGEMENT 54
( 5.2.15. FB100 - OUTPUTS 54
5.3. FC functional description 54
5.3.1. FC5-IN/OUT STATE INDICATION 54
5.3.2. FC101 - AO BLEND SPEED I ANALOG OUTPUT BLENDING (PAW) 54

6. Glossary 55
..
7. Attachments 56
7.1. PLC Structure 56
7.2. Operational Sequences 58

13565_SDS_1_E.docx 5/
58
5E~VOLiFT
~ ,.., . ...,
. .. . '. .

Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo. Brazil

I Date of Version: \23. Dec 2015 \ Version: 1

1. Introduction

1.1. Authorl Authority


This document is the Software Design Specification (SDS). It is used to describe the software
design (modules, function blocks, interfaces, etc.) to enable the control for the Blender as given
in the contract and functional specification.
This document is written and approved by SERVOLIFT GmbH, Germany.

1.2. Objective of document


The purpose of this document is to clearly define the software components (blocks, functions,
modules, etc.) and interfaces of the control devices. With approving the final version of this
specification, it will be used as basis for writing the pic program and the test documents for FAT.

1.3. Contractual Status


This document is an integral part of the documentation to be supplied under the contract.
For change control the current revision status is indicated at the head line on each page.
It will be used as a reference for writing the factory acceptance test documents (FAT).
the installation qualification I operational qualification (IQ/OQ) test documents, which the machine
will be tested against.

The blender will be designed and manufactured to conform to the following standards:
GAMP Guidelines (current version)
all components will be CE certified

(
1.4. Reference Document(s)

Document Version (current indices)

Functional Specification 13565 _FS-FDS

Drawing Blender 1 3565-00-001

Hardware Design Specification HDS 13565_HDS

Hardware - Assignment of sensors I


actuators to Input I Output Cards of PLC 13565_HDS-IO-List

13565_SDS_1_E.docx 6/58
SE=iVOLiFT
f,:' -: ., 1 ,j _ ." . ~.: ,', ".; ..

Software Design Specification (SDS)

Type of Machine: I Container Blender IServolift Project No. 1 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 123. Dec 2015 1Version: 1

2. Overview
The two main elements of the software design are the S7 PLC program and the WinCC HMI
program. The HMI program contains the visualization for operating the machine.
The PLC and HMI program design will be based on SERVOLIFT programming standards.

(
2.1. Program Development

2.1.1. PLC development


The PLC program design will be based on the SERVOLIFT programming standards.
The program will be written in S7 structure. There will also be contained the code to communicate
with the HMI panel. The program will be split into a number of logical blocks each of which
groups an area of operation together. The program will be developed using standard Siemens
STEP 7 application package and when finished be archived and saved onto a backup disc.
PLC/HMI Program (project) Name: 13565.zap13

2.1.2. HMI Development


The HMI software will be based on the SERVOLIFT programming standards. The program will
be developed using the WinCC Advanced application package. The program is integrated in the
pic project and will be archived and saved onto a backup disc at the same file as PLC program,
it cannot be splitted into two separate files.

2,1,3. Software development list

configuration GAMP
software version manufacturer version
software category
V13.0 SP1
SIMATIC TIA Portal SIEMENS 4
13565.zap13 Update 5
1
(PLC/HMI) SIMATIC V13.0 SP1
M ENS
SIE 4
WinCC Advanced Update 5

13565_SDS_1_E.docx 7 I 58
SE=lVOLiFT
Software Design Specification (50S)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1 Version: 1

2.2. Version Control

2.2.1. PLC version


To aid in the version control of the SIMATIC project a change control will be recorded on a
separate document. The valid version number will be saved under the labelling fields together
with other specific project information and is a part of the project. The installed PLC version will
( be displayed on the main screen, called "MAIN MENU" of the HMI.

,'"

2.2.2. HMI version


The HMI configuration version will be displayed on the main screen, called "MAIN MENU"
if selected ENGLISH as operating language.

Example:
IJSt'II MAIN M~NU
()pfllAIOIt _f' ~

IIMlvtn.:QJ

"l(I/E~.:OI +--t----'

13565_SDS_1_E.docx 8/58
SE=tVOLiFT
Software Design Specification (50S)

Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Ita evi - Sao Paulo, Brazil Customer Reference 4500233630

1 Date of Version: 123. Dec 2015 1 Version: 1

2.3. HMI and PLC Interface Design


The diagram shows how the HMI panel will interface/communicate with the PLC
to enable the control buttons, status information and alarm handling to be carried out.
The shown areas refer to PLC areas.

CMD
block function
( DB1 CMD
CMD_POS
DB2 CMD_POS
DB3 COMMON
COMMON
DB5 DB STATE INDICATION
DB STATE DB9 DB HMI SETIINGS
INDICATION
DB99 DB DISTURBANCE
DBHMI DB180 DB SETIINGS MAINTENANCE COMMON
SETIINGS
DB190 DB SETIINGS SUPERVISOR
DB DB92 DB ADVICE MESSAGES
DISTURBANCE
DB68 DB RECIPE COMMON
DBSmlNGS DB66 DB RECIPE SET
MAINTENANCE
COMMON DB67 DB RECIPE ACTUAL
DB90 DB SERVICE INTERVAL
DBSmlNGS
SUPERVISOR DB85 DB FNCT SPEED CALIBRATION
DB ADVICE
MESSAGES
HMI
DB RECIPE
COMMON

DB RECIPE SET

DB RECIPE
ACTUAL

DB SERVICE
INTERVAL

DB FNCTSPEED
CALIBRATION

13565_ SOS _1_E.docx 9/58


SE=iVOLiFT
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laborat6rios S.A.,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 123. Dec 2015 1Version: 1

."
3. System Description
3.1. PLC

3.1.1 . Siemens S7 PLC Program Structure


The following diagram gives an overview of how the program blocks are to be structured.
( Refer to following sections for description of the various blocks.
See in section "Attachments" the screenshot of current program file: "13565_PLC_Structure"

3.1.2. Program Description


The PLC program for the system is divided into a series of blocks. Each block has a specific
function. The blocks are selected as shown by the program structure. Some will run
unconditionally and some are called from other blocks. The block ORGANISATION (OB1) is the
main cyclic scan block and is always called. The block OB1 forms the main program. Block PLC
FIRST CYCLE (OB100) is an organisational block that the PLC system runs for a specific PLC
restart condition. System function blocks SFC are already defined by the supplier of the PLC and
perform a specific function with the user program supplying input and output data when using
them. User defined blocks FC's and FB's are forming the main program control code. Data blocks
(DB's) defined in the system are referenced by the various blocks.

3.1.3. Symbolic Conventions


A symbolic convention will be used comprising same text of an address. This convention
will apply to input, output, flag, timer, counter and data block references as well as block names.

13565_SDS_1_E.docx 10 /
58
SE~VOLiFT
Software Design Specification (SDS)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Ita evi - Sao Paulo, Brazil Customer Reference 4500233630

1Date of Version: 123. Dec 2015 1Version: 1

3.1.4. Program Block Specification Descriptions


The following subsections giving a description of the main program blocks which are making up
the program. Organisation and program blocks are composed of a series of user defined
networks. System function blocks work to a defined set of input and output parameters so no
code is generated for the program. Data blocks are defined by the user as a sequential series of
data references and the type of data so no code is generated for the program.
(

3.1.4.1. Siemens S7 - OB _ Organisation Blocks


Organization blocks (OBs) represent the interface between the operating system and the user
program. Called by the operating system, they are controlling cyclic and interrupt driven program
execution, start-up behaviour of the PLC and error handling. The organization blocks can be
programmed to determine CPU and program behaviour.

The pic program is realized by an event-driven

.
program processing, that means the cyclic program
processing can be interrupted by certain events I Paw ",,,,, I
(interrupts). If such an event occurs, the block / i>11J11<1i'

l '-
-
~~.Jiim,
currently being executed is interrupted at a command
boundary and a different organization block that is
assigned to the particular event is called. Once the
organization block has been executed, the cyclic ~
program is resumed at the point at which it was klrdlmupl1 -

interrupted.

see the graphic on the right, it is an excerpt from:


"SIMATIC programming with STEP 7",
issue 03/2006, A5E00706944-01" S.69/650"

3.1.4.2. Siemens S7 - FC _ Functions


Functions are among the building blocks that a user has programmed. A function is a code block
"without memory." Temporary variables at the FC are located at the local data stack. These data
will be lost after processing of the FC. Global data blocks can be used to store data used in a FC.

Application
A FC contains a program section that is always executed if the FC is called by a different logic
block. FC's can be used for the following purposes:
To return a function value to the calling block (example: math functions).
To execute a technological function (example: single control function with a bit logic
operation).

The description in the PLC program blocks listing illustrates the function of each FC.

13565_SDS_1_E.docx 11 /
58
SE=iVOLiFT
if /:1;'.',;:.
J.

Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Ita evi - Sao Paulo, Brazil Customer Reference 4500233630

I Date of Version: 123. Dec 2015 1 Version: 1

3.1.4.3. Siemens S7 - FB - Function Blocks


Function blocks are among the building blocks a user has programmed. A function block is a
block "with memory". It has an associated data block as memory (instance data block). The
parameters passed to the FB and the static variables are stored at the instance-DB. Data stored
at the instance-DB will not be lost after processing of the FB. Temporary variables at the FB are
( located at the local data stack. These data will be lost after processing of the FB.

Application
A FB contains a program section that is always executed if the FB is called by a different logic
block. FB's can be used for the following purposes:
Complex functionalities
Multiple use of a function

Function Blocks and Instance Data Blocks


If parameters used at a FB, an instance data block is assigned too, which transfers the
parameters. A FB which is called multiple by using a different set of instance data, each data (for
example, speed, ramping, accumulated operating time etc.) will be stored in a different instance
DB.

The description in the PLC program blocks listing illustrates the function of each FC.

3.1.4.4. Siemens S7 - DB _ Data Blocks


In contrast to logic blocks, data blocks do not contain programmed code. They are used to store
user data, in other words, data blocks contain variable data with which the user program works.
Shared data blocks are used to store user data that can be accessed by all other blocks. The size
of DB varies depending on data structure. Shared data blocks can be structured in any way to
suit particular requirements.

Shared Data Blocks in the User Program


If a logic block (FC, FB, or OB) is called, it can occupy space in the local data area (L stack)
temporarily. In addition to this local data area, a logic block is able to open a memory area as like
a DB. In contrast to the data In the local data area, the data in a DB will not deleted when the DB
after the corresponding logic block has been executed.
Each FB, FC, or OB is able to read data from a shared DB or write data to a shared DB. This data
remains in the DB after the DB is exited.

Data blocks will be designed to store data of FB's, providing interface data to other equipment
(HMI). The structure of the blocks will be individually defined as to what the data areas do,
or predefined by calling of a FB.
SE=tVOLiFT
:Jt .. ;
1,1...' .. ,',

Software Design Specification (SDS)

type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 123. Dec 2015 1Version: 1

3.1.5. Siemens S7 PLC Program Blocks Listing

function address comment I description


group module I family
Organisation ORGANISATION BLOCK OBx OB1 ORGANISATION BLOCK
Organisation OB100 RESTARTPLC
Organisation DATA BLOCK DBx DB81 DB WORKING HOURS

AUTO FUNCTION BLOCK FBx FB60 AUTO CLAMP


AUTO DATA BLOCK DBx DB60 DB AUTO CLAMP
it contains following blocks:

BLEND FUNCTION BLOCK FBx FB69 BLEND TIME EVALUATION


BLEND FB64 FNCT* (*=FUNCTION) BLEND
BLEND FB65 REVERSE TIME EVALUATION
BLEND DATA BLOCK DBx DB64 DB FNCT BLEND
BLEND DB67 DB RECIPE ACTUAL
BLEND DB68 DB RECIPE COMMON
BLEND DB66 DB RECIPE SET

CALIBRATION FUNCTION BLOCK FBx FB97 ACTUAL SPEED CORRECTION


CALIBRATION FB85 FNCT SPEED CALIBRATION
CALIBRATION FB87 SPEED CORRECTION
CALIBRATION DATA BLOCK DBx DB85 DB FNCT SPEED CALIBRATION
CALIBRATION DB88 DB SPEED
CALIBRATION DB89 DB SPEED CORRECTION

HMI FUNCTION FBx FC5 IN/OUT STATE INDICATION


HMI FB92 ADVICE MESSAGES
HMI FB99 DISTURBANCE MANAGEMENT
HMI FB81 WORKING HOURS
HMI DATA BLOCK DBx DB1 CMD
HMI DB2 CMD_POS
HMI DB3 COMMON
HMI DB92 DB ADVICE MESSAGES
..
listing continued on next page ...

13565_SDS_1_E.docx 13 /
58
SE=lVOLiFT
I, : . ~ .... " "i.::
.:..:.-~:.
Software Design Specification (SDS)
Type of Machine: I Container Blender 1Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 123. Dec 2015 1Version: 1

function
group module I family address comment I description
HMI DATA BLOCK DBx DB99 DB DISTURBANCE
HMI DB98 DB DISTURBANCE MANAGEMENT
HMI DB9 DB HMI SETTINGS
HMI DB181 DB LIFT ENCODER
DB SETTINGS MAINTENANCE
HMI DB180
COMMON
DB
HMI #NOT USED IN 13565 OB182
SETTINGS MAINTENANCE SLEW
HMI DB190 DB SETTINGS SUPERVISOR
HMI #NOT USED IN 13565 DB185 DB SLEW ENCODER
HMI DB5 DB STATE INDICATION

MANUAL FUNCTION BLOCK FBx FB11 CLAMP


MANUAL FB12 LIFT
MANUAL FB16 TURN
MANUAL DATA BLOCK DBx DB11 DB CLAMP
MANUAL DB12 DB LIFT
MANUAL DB16 DB TURN

AO BLEND SPEED / ANALOG


OUTPUTS FUNCTION FCx FC101
OUTPUT BLENDING (PAW)
OUTPUTS FUNCTION BLOCK FBx FB100 OUTPUTS
OUTPUTS DATA BLOCK DBx DB100 DB OUTPUTS

SERVICE
INTERVAL FUNCTION BLOCK FBx FB90 SERVICE INTERVAL
SERVICE
DATA BLOCK DBx DB90 DB SERVICE INTERVAL
INTERVAL
..
- end of listing -

13565_SDS_1_E.docx 14 /
58
SE=iVOLiFT
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. 1 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1Version: 1

i2. HMI

3.2.1. HMI Access Security


The security system is based on authorizations, user groups and users. If operator controls
protected by a password are operated, the HMI device first requests that the user logs on.
A logon screen is displayed in which the operator enters his user name and password. After
( logging on, the operator is able to operate screen items, which are authorized at the operator
level. After logging off, objects assigned password protection can no longer be operated; to do
so, a log on is needed again.

3.2.1.1. User Groups and Authorizations


These are the preconfigured user groups and their authorizations at point of delivery of machine.

Logoff time
User name Password Group in minutes
ADMIN1 ADMIN1 ADMINISTRATOR 60
MAINTENANCE MAINTENANCE MAINTENANCE 5
OPERATOR OPERATOR OPERATOR 5

SUPERVISOR SUPERVISOR SUPERVISOR 5

The project-specific user groups are created by the configuration engineer. The "Administrators"
and "PLC User" groups are included by default, these groups cannot be changed whether by the
engineer, nor by the customer. User groups are assigned to authorizations. Authorization required
( for an operation is specifically defined for each individual object and function in the project.

Accessibility which is given to a group with a lower access level, is also given to all groups with
higher access level, e.g. functions of "OPERATOR" level are enabled for user assigned to
"ADMINISTRATOR" level.
Software Design Specification (50S)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1 Version: 1

3.2.1.2. Assignment of functions to user groups


The chart (splitted in two parts)
shows which functions are enabled by members of which user group.

User group
(
...
Function -- .. .
0
r a ~
ra
e ... 0
...0
-
.~
1/1
.!!! e

e Q) e
c 'co
.!!
'E Q. Q)
Q.
::::I
~ :il t/) 0

synchronize / adjust date and time of pic and terminal


calibration of touch screen
switch on / off the beep for buttons
change indicated operating language
password management-
to edit, modify and delete user data sets, to backup / restore

change / modify own password
terminate / shutdown running application / visualization

maintenance mode
maintenance settings
calibration of blend speed
service interval settings
service interval confirmation
state indication / diagnosis of pic periphery

recipe management-
to edit, modify and delete recipe data sets
call predefined recipe (if recipe management is selected)
PARAMETER MENU function
input of blend parameter (if no recipe management is available)
TEST RECIPE function
input of batch number
PARAMETER MENU and TEST RECIPE function

reload and indication of finished batches


Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No, 1 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Itapevi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

User group

.. ..
Function
-
e! 0
til
'
'E
CJ
e
IV
C
se
0
til
.~
Q)
Q.
- 0
E
Q)
..
'C 'iii :;, Q.
:!l: I/) 0

BATCH ARCHIVE function

adjust printer settings


printout blend I batch protocol
printout recipe dataset protocol

start I stop blend sequence


manual mode functions

fault I disturbance confirmation


end of chart
Software Design Specification (50S)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 I Version: 1

3.2.1 .3. Users and Passwords


Each user can be assigned to exactly one user group.
The following people are allowed to create users and assign them passwords:
The configuration engineer during configuration
The administrator on the HMI device
( A user with user management authorization on the HMI device
Irrespective of the user group, each user is allowed to change his own password.

3.2.1.4. Logoff Times


A logoff time is specified in the system for each user. If the time between any two user actions,
such as entering a value or changing screens, exceeds this logoff time, user is automatically
logged off. The user must then log on again to continue to operate objects assigned password
protection. The time for automatic logoff is preconfigured to 5 minutes. This value is changeable
at range between 0 to 60 minutes. Therefore Administrator authorization is necessary.

3.2.1 .5. Backup and Restore


The user data is encrypted and saved on the HMI device to protect it from loss due to power
failure. The users, passwords, group assignments and logoff times set up on the HMI device can
be backed up and restored. This prevents you having to enter all of the data again in case of
hardware failure.

3.2.1.6. Limits of users and passwords

No. of characters
minimum 3 character, maximum 40,
Length of user name
not "key sensitive", that means "MAX" and "max" are one user
minimum 3 character, maximum 40
Length of password "Key sensitive", that means "operator" and "OPERATOR" are two
password
User entries per user group minimum 1, maximum 50
User entries maximum 50 (system limitation)

The following characters should not be used in passwords:


Blank
Special characters * ? . % I \ ' "

The min. and max. parameters for user names, user passwords, max user entries are fixed.
The logoff time is configurable by users with administrator authorization only.

3.2.1.7. Extended security and access control requirements, deviations from SL standard
There are no deviations from Servolift standard configuration for password and user management.
5E~VOLiFT
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 123. Dec 2015 1Version: 1

3.2.2. General Screen Layout of HMI menus

The picture below shows the general layout of menus and submenus, displayed during operation
of the machine, divided into 3 parts. Generally, a menu consists of 3 information and actuating areas:

Head line (permanent)


Each line contains information as plain text or graphic and
( Message or information line
command buttons to start or stop functions of machine.
Function line

headline: The headline is indicated in all menus, showing following information.

1 2 3 4 5 6 7
\ /
$1[[. SE=lVOLiFT
EUROFARMA
13565
23/12/2015 10:10,54

USER MENU PRINCIPAL


ADMIN 1

no. function
1 to show communication status between PLC and HMI terminal, blinking green symbol means "OK"
2 to show current logged in user by indication of user's name, e.g. here "ADMIN1"
3 to show screen name,
here in selected operating language PORTUGUESE, e.g. here "MENU PRINCIPAL"
4 to show project / machine number, e.g. here "13565",
5 if available the customer specific machine definition is displayed too, here "Merck, Brasil"
(this is only a recommendation, input is changeable by specific user groups)
6 to operate function keys LOGIN / LOGOUT, to enable operation of the machine after login
7 to show time / date, to enable modification

13565_SDS_1_E.docx 19 /
58
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

information line:

Here the indication of messages (advise messages, alarm messages, etc.), current of PLC and HMI
version are indicated. Also you can find the current state of working hour counter and select which
operating language should be used. The indication of message depends on message type. For showing
fault message they will be framed with red bar. To be able to confirm alarm messages the coloured
message bar has to be touched to open a separate menu.
USER MAIN MENU
ADMIN!

ALARM

Advice messages occur during the whole operation and be in plain text framed with a blue bar to indicated
machine end positions or missing start conditions. An acknowledgment of those messages is not
necessary. As soon as the movement is continued or a function is selected by pressing the corresponding
the dis will disa automati

13565_SDS_1_E.docx 20 /
58
SE=iVOLiFT
~ilt::.'.
' 'L, ,.:i .. _ .. :'

Software Design Specification (SDS)


Type of Machine: I Container Blender 1 Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

[ Date of Version: [ 23. Dec 2015 [ Version: 1

function line:

t-iere several function keys are indicated to open corresponding submenus.

OPERATOR MAINTENANCE SUPERVISOR AOM.IN.


MENU MENU MENU MEN~

If operating language PORTUGUESE is selected:


_
.
r+=

_~ _j I-~~ J MENU
SUPERVISOR MENU
~~-
1

The operating buttons


ClP{ItATOA

will be shown graphically either as active (light-grey) : ""'" or inactive (dark grey)
This shows, if the implementation of the chosen function will be possible.

3.2.3, Operating I Terminal Language

After initializing of the HMI-terminal the PORTUGUESE language is loaded as operating language.
Now the user has to enter a valid user identification, consisting of name and password. After successful
login it is possible to operate the machine according to the assigned menus and functions.
To change indicated language on the HMI repeat activation of the button with national flag in MAIN MENU
(first screen after initialization is finished) until required language is signalized by the corresponding
national flag. Afterwards, all messages, labels and legends will be displayed in selected language. After
translation work during programming period all texts, messages, alarms, etc. are available in this
language at the HMI-terminal. Further selectable operating languages will be ENGLISH or GERMAN.

13565_SDS_1_E.docx 21 /
58
SE=lVOLiFT
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

3.2.4. Screen overview / Menu navigation

The following scheme gives an overview of the general screen / menu structure.
Here it is displayed in ENGLISH and PORTUGUESE.
When initialization of HMI is finished successfully the PORTUGUESE language
will be the loaded as operating language.
(

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SE=JVOLiFT
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Software Design Specification (50S)

iype of Machine: I Container Blender


I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

3.2.5. Detailed Screen Description

See on following pages


an excerpt of the layout of several screens which can be started by operators from operator panel
with installed HMI-terminal. The screens are shown in operating language PORTUGUESE.

3.2.5.1. Main menu


(
functions can be done users:
EUROFARMA
Q~/OI12otG u.O&,U
SE:tVOLiFT 13565
USER MENU PRINCIPAL
AOMINI

HMIVER.,OI

PlCVfR.: 01
IIORAS O~ OI'flUlCAO, 4106

n r
.:...~. :.
- C .~

_UDO
0Pf1lAOOR 1
I_
IilfNU
SUPERVISOR
]
2 3 4 5

no. function
1 change operating language, => here PORTUGUESE is loaded after first start of application
2 selection of OPERADOR MENU which contains further sub-menus and functions
3 selection of MENU MANUTENCAO which contains further sub-menus and functions
4 selection of MENU SUPERVISOR which contains further sub-menus and functions
5 selection of MENU ADMINISTRADOR which contains further sub-menus and functions
SE=iVOLiFT
.",.. I; ,". :',

Software Design Specification (50S)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


'Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.2. Operator menu

Followi functions can be done users:


USER OPERATOR MENU
ADMIN!

.~ "

MENU
TEsn NENUDl
PARAMIElRO
RfalTA
J _ 1(15lURA

1 2 3 4 5 6

no. function
1 selection of MODO MANUAL menu to start any manual actuated function / movement
2 selection of MENU PARAMETRO to select an defined blend recipe
3 selection of TESTE RECEITA to enter single blend parameter, which will NOT be stored
4 selection of MENU DE MISTURA to start and stop the blend cycle / the rotation
5 selection of ARCHIVO GRUPO to load archived batches
6 function key EXIT to close current menu / return to previous menu

13565_SDS_1_E.docx 24 /
58
SE~VOLiFT
Software Design Specification (50S)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Ita evi - Sao Paulo, Brazil Customer Reference 4500233630

I Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.3. Maintenance menu


functions can be done users:
usm MENU MANUTENCAO
ADMIN I

(
SERVOUFT Gfllbn
Service: Ilotllne:

Em"ll: servlce@scrvollh.de

t
www.scrvollft.de

Finnwarc UMI: 4
Hrrnware Ple: 4

1-
c
.V' (1:_ :; 6

MAN~NCAO j MIAJUN5uTnA
NM(Al:ON
J 7
lOS

1 2 3

no. function
1 call MODO MANUTENCAO menu to start manual actuated function without interlocks
2 call MENU CALIBRACAO to calibrate blend speed
3 call menu MANUTENCAO AJUSTAMENTOS
for setnnqs 1 modifications of correct horizontal positioning of supporting arm
4 call menu SERVICE INTERVAL
for indication and confirmation of service interval messages, or to reset service intervals manually
5 call menu STATE INDICATION
for display and supervision of data input! output channels, data sets, and flaas from or to the PLC
6 call menu ALARM HISTORY
to call overview list for indication of all occurred alarm messaoes after switchinc on power supply
7 function key exit to close current menu 1 return to previous menu
SE=-1VOLiFT
Software Design Specification (50S)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 I Version: 1

3.2.5.4. Supervisor menu

USER MENU SUPERVISOR


AD~1INl

~
I
,
.~

1 2 3

no. function
1 selection of ADMINISTRACAO RECEITA menu to edit, modify or delete defined recipes
2 selection of AJUST A A SISTEMA menu to activated / deactivate starting of printout
3 function key EXIT to close current menu / return to previous menu
SE=iVOLiFT
Software Design Specification (SOS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.5. Administrator menu

Following functions can be done by users:


USER ADMINISTRATOR MENU

ADMIN!

'NO.,
TIME
TEXT 1
IlHil!lI"iiiNe'U_"ijI"Ul!I"I_lnail~I.ttttftt1tffiti'f'ii'il'ili!;','ij!liifi ..i.Ui.iUli
(

7 , 13 I

2 3 4 5 6

no. function
1 display system messages,
messages will be logged continually, max. 500 messages, then the first will be overwritten
2 calibration of touch screen
3 adjust tap "beeper"
4 to call USER MANAGEMENT menu
to edit, modify or deactivate user assignments to functions / menus
5 shut down application and return to control panel system settings, e.g. for backup/restore
6 function key EXIT to close current menu / return to previous menu
5E~VOLiFT
Software Design Specification (50S)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1 Version: 1

Now will follow the sub-menus of the main previously shown menus:

3.2.5.6. Manual mode menu

After having called the OPERATOR MENU from MAIN MENU and pressed key MANUAL MODE
fpllowing menu is displayed. It shows and contains all manual functions which are needed e.g. to position
( supporting arm with inserted container to correct height position to enable blending or discharging cycle.

r
Following functions can be done by users:
;':LlSH as operating language is loaded~""M'o"

jI
1 3 5
2 4 6
(
7 8

no. function
1 function key LIFT, to move to next height position until mechanical end position is reached
2 function key LOWER, to next height position until mechanical end position is reached
3 function key CLAMP, to fix inserted container in the supporting arm to enable rotation
4 function key UNCLAMP, to unfasten inserted container to enable removing it
5 function key TURN LEFT, to enable manually activated rotation in anti-clockwise direction
e function key TURN RIGHT, to enable manually activated rotation in clockwise direction
7 function key ACTIVATE SAFETY CIRCUIT,
to switch on safety module and continue cycle
8 function key EXIT to close current menu / return to previous menu

1356S_SDS_1_E.docx 28/58
SE=iVOLiFT
': e. f ". ';..:

Software Design Specification (SDS)

Type of Machine: Jcontainer Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 I Version: 1

3.2.5.7. Parameter menu

Following functions can be done by users:


USER PARAMrnR MENU
ADMIfU

( RECIPE

tsAMPLE RECIPE 1 ....::-- 1

PRODUCT NANE,

PRODUCT NUNOI;R,

SHI'l

OL[NDTIN[ ININ)

BLEND REVERSE TINE (NIN]

OL(ND SP[[D I RPM]

PROOUCT LEVWNG [NS) f2000 -.

u- 3

( no. function
1 selection of recipe (dataset with predefined blend parameter) without modification

2 input of BATCH, after selection of recipe,


it is a needed start condition for blend cycle and have to be filled
3 function key EXIT to close current menu / return to previous menu

13565_SDS_1_E.docx 29 /
58
Software Design Specification (SDS)

Type of Machine: I Container Blender 1 Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1 Version: 1

'.

3.2.5.8. Test recipe menu

Following functions can be done by users:


USER TEST RECIPE
ADMIN I

(
TEST RECIPEI ONLY fOR TEST PURPOSES

_j
PROOUCT NAME,
1
PROOUCT NUM8Rl

STtP I

BLEND TINE (MIN)

BLENt) REVfRSE liNE [MIN)


fo ... -
BLEND SPEED (RPM)
ie - ._
PAOOUCILEVfLLING (145)

BAlCHI
...-. 2
{j-+ 3

no. function
1 input of single blend parameter which will not be stored, only be valid for next blend cycle
2 input of BATCH, it is a needed start condition for blend cycle
3 function key EXIT to close current menu I return to previous menu
5E=JVOLiFTr."...... 1 _ .. :;~:.)

Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma t.aboratortos SA,


Customer: Customer Reference 4500233630
Itapevi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 I Version: 1

3.2.5.9. Blend menu

Following functions can be done by users:


USER BUND MENU
AJ.)MU41

_lI.L.l'~'p_I~!\!WtJl~IHQ~~Q _
( ___ ____ ___________________
_
_____ _ _

0,00
1
BLEND nME (MINI I MIN AOUAL> MIN

10 20 30 40 50 60 70 80 90 100

8LENO REVERSE TIME (MIN) o MIN ACTUAl, 0,00 MIN

10 20 30 40 )0 60 70 80 90 100

BLEND SPEED (RPM) 08 RPM ACIUAL, 0.0 IlPM

10 11 U J3 14 IS 16

BLEND STEP ACTIVE,

RfOPE, !lAMP' E RECIPE I

PRODUCT NAME, AIlCIlH

PRODUCT NUMBER, 12345

BATCH, 4/11"1
-

START

2 3 4 5 6

no. function
1 summary of blend parameter,
loaded either from PARAMETER MENU or entered in TEST RECIPE menu
2 control blend cycle - key START,
if shown light grey all start conditions are fulfilled, start is possible
3 control blend cycle - key STOP,
if shown dark grey, function cannot be started, here stop is only possible if it was started
4 function key ACTIVATE SAFETY CIRCUIT to switch on safety module and continue cycle
5 function key PRINTER to start printing batch report, manual actuated
6 function key EXIT to close current menu / return to previous menu

13565_SDS_1_E.docx 31 /
58
SE=iVOLiFT
Software Design Specification (SDS)

Type of Machine: I Container Blender J Servo lift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.10. Batch Archive

Following functions can be done by users:


USER BATCH ARCHIVE
ADMIN!

RECIPE,

( PRODUCT NAME.

PROOUCT NUMBER:

BATCH,

STEP 1 PRESET, ACTUAL:

BLEND TIME [MIN) 0:00 0,00

BLEND REIlERSE TIME (MIN) 0:00

BLEND SPEED [RPM) 0

BLEND STARTED. 01/01/199912100:00

BLEND STOPPED, OJ/01/1999 12:00:00

BlEND STAn, BUMO NOT STARtED

BLEND STARTED BY,

1 2 3

no. function
1 function key PRINTER to start printing batch report of reloaded batch
2 call of ARCHIVE INDEX menu to ease the selection / reloading of finished batches
3 function key EXIT to close current menu / return to previous menu

13565_SDS_1_E.docx 32 /
58
SE=tVOLiFT
-,:"',i.:; ".('t .. , :":,'
S:'

Software Design Specification (SDS)

Type of Machine: I Container Blender IServolift Project No. 1 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.11. Archive Index

Following functions can be done by users:


USER
I\DMINI
ARCHIVE INDEX

[]~
NO NAMEI
( (

(
t! J
1
(

( SELECTION.

2
( 0
(

OVERALL:

I 0 3
u

u
0
"'1 -t. j:
1

. I
4

no. function

1 the chart shows the index of available and reloadable batch reports,
it contains maximum of 16 datasets, if more than 16 datasets exist
the keys "up" and "down" have to be pressed to scroll through it
2 entry field for directly input of dataset number of selected finished batch to reload it
3 indication field to show the full amount of existing datasets
4 function key EXIT to close current menu I return to previous menu

13565_SDS_1_E.docx 33 /
58
SE~VOLiFT
Software Design Specification (SDS)

Type of Machine: I Container Blender IServo lift Project No. 1 13565

Eurofarma Laborat6rios SA,


Customer: Ita evi - Sao Paulo, Brazil Customer Reference 4500233630

1 Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.12. Maintenance mode menu


Following functions can be done by users:
- Selection of manual functions which can be operated without interlocks for adjustment or
.:. ... in case of a malfunction and machine stopped in indefinite position to bring back in defined position.

I ~"'"' MAINTENANCE HOOE

IrJ
ATTENTION DANGER:
OPERATION WITHOUT SAFETY INTERLOCKS. OPERATING
ONLY FOR TRAINED PERSONNEL ALLOWED.

ClAMP
UlliN
lIFT UH

lUAN
RlGHr

1 3 5 7
2 4 6 8
9 10

no. function
1 function key LIFT to move to different height positions until end position is reached
2 function key LOWER to move to different height positions until end position is reached
3 function key CENTER CYLINDER OUT
to move centerinq cylinder out, included in function clamp
4 function key CENTER CYLINDER IN
to move centering cylinder in, included in function unclarno
5 function key CLAMP
to fix inserted container in the supporting arm to enable rotational movement
6 function key UNCLAMP to unfasten inserted container to enable removing it from cage
7 function key TURN LEFT to enable manually activated rotation in anti-clockwise direction
8 function key TURN RIGHT to enable manually activated rotation in clockwise direction
9 function key ACTIVATE SAFETY CIRCUIT to switch on safety module and continue cycle
10 function key EXIT to close current menu / return to previous menu

13565_SDS_1_E.docx 34 /
58
5E~VOLiFT
i .. :,.':'.::",,':.i'c .J. :ri'".i~

Software Design Specification (50S)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

/ Date of Version: /23. Dec 2015 / Version: 1

3.2.5.13. Calibration menu

Following functions can be done by users:


- Control of calibration cycle (start; stop) for blend speed adjustment

USER
CALIBRATION MENU
AOMINI
(
BlE~D ,FEEO 11\Pfo1) 05 RFN .\CTUAl a 0 RP'"

to 11 II 15 Lo

ENTRV,

81 fNO SPEED (RPM) 5 RPM

1 2 3 4 5

.no. function
1 control blend cycle - key START,
if shown light grey all start conditions are fulfilled, start is possible
2 control blend cycle - key STOP,
if shown dark grey, function cannot be started, here stop is only possible if it was started
3 change direction of rotation during calibration sequence - key REVERSE
4 function key ACTIVATE SAFETY CIRCUIT
to switch on safety module and continue cycle
5 function key EXIT to close current menu I return to previous menu

13565_SDS_1_E.docx 35 /
58
SE=iVOLiFT
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.14. Maintenance settings

Following functions can be done by users:


- Adjustment of proximity switch for correct 0 turn positioning

USER MAINTENANCE SETTINGS


( AUMINI

AITENTION DANGER:
OPERATION WITHOUT SAFETY INTERLOCKS.
..
~ OPERATING ONLY FOR TRAINED PERSONNEL ALLOWED.

00 PROXIMITY
SETIINGS
swnca 1
TURN R1GHl't 8 loiS

lURN LEFTI
tuRH
LEfT 2
BLum:

CALIBRATION TURN
RIGHT
3
OISlUR8ANCE:
4
5

no. function
1 key CONFIRM MESSAGE,
to confirm warning to enable oQerating displayed function
2 parameter values and function keys, as long as warning is displayed
and NOT confirmed the parameter values and function keys are blocked,
input boxes for adjustment of 0 prox. switch position at supporting arm
3 parameter values and function keys, as long as warning is displayed and NOT confirmed the
parameter values and function keys are blocked, keys TURN RIGHT and TURN LEFT,
function keys to rotate supporting arm manually in anti-clockwise direction or in clockwise
direction to adjust prox. switch of 0 turn position, in general keys have the same functionality
as in menu maintenance mode
4 function key ACTIVATE SAFETY CIRCUIT
to switch on safety module and continue cycle
5 function key EXIT to close current menu / return to previous menu
SE=iVOLiFT
. Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma l.aboratorlos SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.15. Service Interval

Following functions can be done by users:


Display service interval messages
Possibility for manual reset of service interval
" Open Archive Interval (history, only readable)

Information: The displayed screenshot is only an example:

I USER
ADMINI
SERVICE INTERVAL

j---------------------------------------------------------------------------
, III TEXT
. .
STATE
----I
I ilfdldlSM'hilUMI'II9"dii'"" 1 :
Fil' NUtt
lIur
I
I

!, lL~ I
I

~I'================================~~~======================~
I I

I
I
---I
I PRESElECT
I
I
. INTERVAL
2:
I SERVICE INTERVAl [)(PIRE.OI
: I], MAINTENANCE EVERY 6 MONTH 24/10/2015
I I., MAINTENANCE EVERY YEAR 13/"4/1016
!
:_I~,~I~T~'!.A~<:.E~V~~Y!!~A~ '~J_04-'~I!?~ _

r--------------------------------------------------------------------------- ---,
3: I
I
I
( I

4: ,
I

~--------------------------------------------------------------~
I

no. function
1 to display current SERVICE INTERVALS, to show present messages in the overview list and
the functions keys to confirm and reset messages,
to display upcoming service intervals in text-in-clear and to give possibility to confirm and to
reset indicated messages when activities done, if current date corresponds with upcoming
rj~l
interval date the icon 1.;C1 will be shown flashing at head line, if pressinq this icon, this menu will

be opened directly, indicated function keys are used for _


[[J
CONFIRMATION,l
1"", RESET and
HELP, to be informed in detail about the work to be p_erformed
2 to display time values of upcoming SERVICE INTERVALS, upcoming service intervals are given
in text-in-clear and can be reset manually by input of interval number at input box "PRESELECT
INTERVAL" and then to press key RESET
3 call menu ARCHIVE INTERVAL, to display all recorded interval messages, only readable
4 function key EXIT to close current menu / return to previous menu
!! "".~i:. _
""~.::l":,:
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123, Dec 2015 1 Version: 1

3.2.5.16. State Indication

Following functions can be done by users:


USER STATE INDICATION
ADMINI

INPUTS OUTPUTS
2
, BYTEI 124 IBVTE! 124

Blli 0 0 ern 0 0
10 10 3

...2 0
sO
20
3

40
50
60
o
4

no. function
1 monitoring of pic periphery
after having selected the connection type In first column, e.g. the used cpu type
2 function key to activate "monitoring mode" and to show current status value in last column
3 indication of current state of input and output of selected byte, e.g. 124
4 function key EXIT to close current menu / return to previous menu

13565_SDS_1_E,docx 38/58
SE=iVOLiFT
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.17. Alarm Archives

Following functions can be done by users:


USER ARCHIVE ALARMS
AOMlt41

( no. function
1 summary and indication of all occurred alarms after having turned the main control on,
overview is only readable, modifications impossible
indication of different states:
- "K" means incoming alarm, message line shown red
- "KQ" means incoming and quit, incoming alarm is confirmed, line shown in yellow
- "KQG" means incoming, quit and gone, incoming alarm is confirmed and reset, line is
shown in green
2 function key EXIT to close current menu / return to previous menu

13565_SDS_1_E.docx 39 /
58
SE=lVOLiFT
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, 4500233630


Customer: Customer Reference
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.18. Recipe Management

Following functions can be done by users:


USER RECIPE MANAGEMENT
ADMINI

( I - - - .---.-----.-----
R E C IP E
--. -- --.-.---.--.-------.---- .-._.---- --_.--:; 1

PRODUCI Nl\Mlo

AAOOUCT NUMBERt

I------------+-c-------------.------------l
r.234~
BL~NI) IIMC (MINI

BlENI> R>V{RSF IIHE I.MIN)

BlrHI) SPI (I) IRI'M( 1 --


PROOl)CIl~II{LUNG IMS)

lusn

* _J ~ J ~ J

~l.J

2 3 4 5 6 7 8

no. function
1 select defined recipe dataset by designation from drop down list or
create recipe dataset and put in new designation after having pressed key (2) NEW
2 function key NEW, to create new recipe dataset and enter new designation in field RECIPE
3 function key MODIFY, to modify / change single parameter of an existing recipe dataset
function key SAVE, to store new created recipe dataset or changed recipe parameter
4 function key DELETE. to delete an selected recipe dataset completely
5 function key PRINTER, to start printing selected recipe dataset
6 function key to export recipe
7 function key to import recipe
8 function key EXIT to close current menu / return to previous menu
SE=iVOLiFTr-r.I, "" .::' 'I, '

Software Design Specification (50S)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


'Customer: Customer Reference 4500233630
Itapevi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.19. System settings

the following screens shows only a recommendation, modifications are possible but only
by users which are members of user group SUPERVISOR or ADMINISTRATOR:

USR SV5nM SETTINGS


ADMIN I
(

: BLEND PAAAMETR SETIINGS


PRINTER SEmNGS
ENTRY NEW BLEND PARAMETERS:
1 PRINTOUT START ATI
3
:~ ENTER BATCH AGAIN
I .../ ; BlEND FINISHED
--'
!.../
L...:.-..;
ENTER PRODUCT OATA AGAIN ~ STOPBYOPERATOR

~ STOP BY DISTURBANCE

X ENABLE SCREENSHOT

PROor BATCII EHTRY,


2 CUSTOMER SPECIfiC
MACtIlN[ O(rtNmON: 4
LL PROOf ENTRY

I MIN NUMIlER or SIGNS

i ~o MAX NUMBER OF SIGNS

no. function
1 function for setting up the entry of new blend parameter, can be activated or deactivated
2 function for proof of batch entry, can be activated or deactivated
3 function for printer settings and the selection when the print out should start

4 entry field for input of customized project number, maximum of 40 characters, if something is entered
it will be displayed on each menu in the head line above the project number and it will be on protocols
5 function key EXIT to close current menu / return to previous menu
SE~VOLiFT
'.-i_,.:.; '. ; _ .. ,:,: " :.'., '.

Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratorlos SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.20. User Management

Following functions can be done by users:

The following menu shows a chart with 4 columns, each must be filled when creating a new user:
USER USER MANAGEMENT
ADMIN I
(
"'---_~~~ o-............c'_..,....
........... f I)",IN'''II{''''J( 5

....,.
ADMINl f ADMINISTRATOR 60
MAINTENANCE I MAINTENANCE 5

OPERATOR
f.......... 1USER
- :\1,. mltltl
[5

:~:~-~-
t/ If 5
ADMINISTRATOR 5
SUPERVISOR 5

~-.._.R_._.._-.-._-.
I

i i

-.--r:::::::
------ ..-- - .. - - - ..._-.---. - ..... - '-'1
I.

1 2 3 4

no. function
1 column 1: "User",
contains the user name as displayed in the head line of each menu and
which gives the possibility to operate the aSSigned function in the corresQonding menus
( 2 column 2: "Password",
contains the user specified password, is shown hidden
3 column 3: "Group",
contains and shows assigned user group and
determines therefore the possibility to control corresponding functions
4 column 4: "Logoff time",
contains and shows the time value at which time the current logged in user
will be logged out automatically_if now function key or other control is done on the HMI
5 function key EXIT to close current menu I return to previous menu
SE=iVOLiFT
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

3.2.5.21. Alarms

Following functions can be done by users:

After having touched the red framed alarm message bar ...
USER MAIN MENU
ADMIN I
(
HMIVER.,01
PlCVER.,OI

... the corresponding menu will be opened:


ALARMS

ALARM
L ... _ _ ~_ _ _ ........ _ _

2 3 4

no. function
1 to display fault / alarm message in text-in-clear with time and date stamp
2 function key CONFIRM, to enable confirmation occurred alarm / fault message
3 function key RESET,
to enable reset of confirmed alarm message and to continue functional sequence
4 function key EXIT to close current menu / return to previous menu
l ....;:.'.;,~.,. , .. ,
..
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123.Dec 2015 1 Version: 1

4. System data
4.1. Systeml Machine Parameter
Following system / machine parameter settings used in this design:

4.1.1. 0 proximity switch settings


( Here it is possible to adjust the correct horizontal positioning
of supporting arm after rotational movement (function blending, turning, calibration).

data
parameter unit min. value max. valu e
type
0 PROXIMITY SWITCH
SETTINGS:
TURN RIGHT integer ms 0 990
TURN LEFT integer ms 0 990
BLEND integer ms 0 990
CALIBRATION integer ms 0 990
DISTURBANCE integer ms 0 990

This is the corresponding screen / menu selectable on HMI-terminal.


It is a submenu of MAINTENANCE MENU:
us,U HAlN'TfNAHa SrnlNGS
ADMltU

Ell
ATTINTlON DANGER:
OPERATION WITHOUT SAFETY INTERlOCKS.
OPERATING ONLY FOR TRAINED PERSONNEL ALLOWED.
- - -

{I~ "HO)('N!tY C;Wllf11


'I I I INt,,,,

IUItH HIlI"'l

IUHNI''': IUIH
UYT
BliND;

...........,
fAllIUIAllIHI

1U.,11j1U'IAN('1

Detailed description of how to use this menu and modify the values
will be given in owner's manual document at a later time (if the programming is finished).
SE=&VOLiFT
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1 Version: 1

4.1.2. batch entry setting

Here in this menu it is oossib e to de f ine the handling 0f entr, for blend
data. parameter data type activated deactivated

LxJ
ENTER NEW BLEND DATA
- BATCH AGAIN check mark
- PRODUCT DATA AGAIN II v' II

This is the corresponding screen / menu selectable on HMI-terminal.


It is a submenu of SUPERVISOR MENU:
USlR SYSUM SfmNGS
MlMINI

,- --- -------
: BLEND PAAAM1ER SEnlHGS
------ ----------- PAINTER SnIHGS
: fNTRy NEW BlEND PAAAMETEASI PRINTOUT START ATt

::'
,
../
_ ENTERBATCHAGAIN I ;_
!..-..!
1 8lENO FINJSHEO

i _.:{
I
fNTfA PAOOUCT OATA AGAIN ~ &10.. Y.,..RATO.

~--------- - -- ------ - --- i


~ 5TOPBV DISTUR8ANC
------
LJ (HA8lE SCR(EHSltoT

CUSlOMER SPECIFIC
"ACHINE DfINllIONI
PAOOf BAlCH ENlRYt

!_.:{ PROOF ENTRY

I MIH NUMBER OF S.IGNS

40 MAX NOtoIBEA. Of SIGNS

Detailed description of how to use these functions


is given in owner's manual document at a later time.

13565_SDS_1_E.docx 45 /
58
5E~VOLiFT
Software Design Specification (50S)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123.Dec 2015 1 Version: 1

4.1.3. system settings, general

Here it is possible to define the minimum and maximum number of characters which the batch
number should consist of. It is also possible to activate a checkmark, so that batch number will
be checked when input is finished and confirmed.

parameter data type unit min. value max. value

PROOF BATCH ENTRY


check
mark
- - -
MINIMUM NUMBER integer - 1
MAXIMUM
NUMBER
MINIMUM
MAXIMUM NUMBER integer - NUMBER
40

This is the corresponding screen I menu selectable on HMI-terminal.


It is a submenu of SUPERVISOR MENU:
lJS[R
5YST!M 5EmNOS
.l\I)MINI

BlEND PARAMETER ST11NGS


PAIN1ER STTtNGS
ENTRV NEW 81.(ffO PAAANElfRSl
PnJNTOUT STAAT All

1../ fNTfR MYCH AGAIN

'-- ~ BlEND F1NlSHED

~ fNtRJ'flOOuCTDATA"QAJN
~ STOP8VOl'{RATOQ

_2:5j SlOP BY OIS'lURISANCE

X ,! ENABlE SCRrENSHOT

: PROOF BATCH ENTRVl


CUSTOHE"R spctnc
MACHINE DEFINITIONI

~: -./ PROOf ENTRY


,--
, I---~'

:,. ..
.,

:i 1 MINNUM8ROfSI<lNS

II
L.
40 MAX NUMBER OF SIGNS
_

Detailed description of how to use the function PROOF BATCH ENTRY


is given in owner's manual document at a later time.

13565_SDS_1_E.docx 46 /
58
SE~VOLiFT
1,':;,".1:.'.',"',:"::",

Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratorlos SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 I Version: 1

,
4.1.4. printer settings

Within this menu it is possible to select general system settings, as well as printer settings.
This menu is also used for adjustment of system functions, e.g. for activation / deactivation of
functions for handling input of data.

( parameter data type activated deactivated


PRINTOUT START AT
- BLEND FINISHED
- STOP BY OPERATOR
- STOP BY DISTURBANCE
check mark Ii vi' :1 I~I
This is the corresponding screen / menu selectable on HMI-terminal.
It is a submenu of SUPERVISOR MENU:
USf. SYSTeM SrmNGS
AONINa

,--" -_ ...... --- ------ --- ----


.
8. (MD PARAMET[A. SETTINGS I PAlNTR SEnlNGS
[NTRY HEW kENO PAAANETERS: : P1UNTOUT STAAT ATI

l._..I' _
f

! ../
....... BUND rlNISH(O
! 'oTt. BATell..... 0
,
i~ I [H1ERPROOUCTOATAAG.\I,N : )\ STOP BY OHRA1OA
'--'
l---:
: X STOP BY DISlUABAN(f
:-
: X
:_ -_ ---~.. -_ .... _-_ ..--- -----
EHAIlE SCA[[N~OT

PROOf BATCH [NTRYl CUSTOMER SffCIFIC


MACHINE DftlNm'OHI

i -.i ., '.OOH"TRY
1"'-
I
1 NIHNUMBlROFSIGNS

fO. -.~ ..
, 040 MAX NUN&R Of.SIGNS,

Detailed description of how to use these functions


is given in owner's manual document at a later time.

4.1.5. customer specific machine definition

Here it is possible to define an additional labelling if project number alone is not enough. The
range for input of alphanumeric characters is maximum of 20. If entered an additional labelling it
will be shown at the head line and on each report, which can be printed from BLEND MENU or
from RECIPE MANAGEMENT.

CUSTOMERSPEClAC setting and result (screens hot from another project...)


MACHINE DEFINITION I _~ \

I ~LENDER 1
~
...
..--- ' ,
~------~.~L~~Nb~eR-l-------------------'
SE=tVOLiFT 1356, t:. 'l/I'IlOIS W15,5S

SYSTlM SUTIHGS

13565_SDS_1_E.docx 47 /
58
SE=iVOLiFT
~::.:"':.: " .:~:~,,-.:.~/.":j} ..

Software Design Specification (50S)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, 4500233630


Customer: Customer Reference
Ita evi - Sao Paulo, Brazil

i Date of Version: 123. Dec 2015 1 Version: 1

4.1.6. Message Handling


The control system will monitor the status of the system devices related to the various operations
and will generate appropriate alarms if an error is detected. When an alarm is generated it will
inhibit the starting or will stop blender operations. Alarms will be displayed in a separated screen
on the HMI in text in clear (as shown in following table), with date and time stamp. When an alarm
has been generated it will have to be reset by the user via a specific screen control on the HMI.
(
After an alarm there will be no automatic restarting.
4.1.6.1. Alarm messages
Alarm messages will be displayed on red background which will be shown at HMI while operational
sequence is running and a malfunction is present. The running sequence will then be interrupted until
fault has remedied.
HMI

.. . .
PLC message
number in block displayed alarm message
DISTURBANCE ,
MANAGEMENT
FB99 I DB99
.n. ....
.,.C("
~. : ''I 'nm~
1 FUSE 24V DC GENERAL SWITCHED OFF
3 E-STOP HMI PRESSED
4 E-STOP BLEND ROOM PRESSED (SPARE, FOR FUTURE E-STOP)
20 SAFETY DOOR 1 OPEN
24 FUSE I OVERLOAD RELAY SWITCHED OFF
26 E-STOP MODULE NOT ACTIVE
27 E-STOP MODULE READY
(
30 LASER SCANNER MODULE NOT OK
33 ARM NOT AT BLEND HEIGHT
35 BLEND SPEED OUT OF RANGE
41 TIMEOUT 0 PROXIMITY SWITCH FLAG
42 FAILURE 0 PROXIMITY SWITCH
48 MAIN POWER SUPPL Y LOST
49 TIMEOUT SENSOR AT SPROCKET
50 FAILURE MAINS CONTACTOR HYDRAULIC PUMP
54 COMMUNICATION PLC - HMI DISTURBED
55 HMI MEMORY CARD READ I WRITE ERROR
65 CONTAINER NOT IN POSITION
66 CONTAINER NOT CLAMPED
72 CENTERING CYLINDERS COMPLETELY EXTENDED
74 TIMEOUT AUTO CLAMP
82 TEMPERATURE HYDRAULIC OIL EXCEED
84 TEMPERATURE BLEND MOTOR 1 EXCEED
88 FAILURE FREQUENCY CONVERTER BLEND MOTOR
End of list. Find description to each fault in owner's manual, section "Troubleshooting"

13565_SDS_1_E.docx 48 /
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SE=tVOLiFT
Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Ita evi - Sao Paulo, Brazil Customer Reference 4500233630

1 Date of Version: 123. Dec 2015 1 Version: 1

4.2. Communication to extern systems


There are no interfaces or signal exchanges to external controls.

4.3. Recipe data


A recipe data set contains following data to run the blending cycle.
(
This screen is indicated if ENGLISH is selected as operating language at HMI:

1 -
_~.
.,, ._~ _. ._ N'_" _ _.~. _ ..

i~~~::=~:~=~~~~~:=::~=_==:-
'ItOOVCfNAMe, fADcorF

2 - ~~~~~~ .

=:~~~~ SUPl

--_---.----------._-

data
line parameter unit minimum value maximum val ue
type
1 PRODUCT NAME string 0 40 characters
2 PRODUCT NUMBER string 0 40 characters
3 BLEND TIME string minute 1 99
(
BLEND
4 REVERSE TIME
integer minute 0 99

5 BLEND SPEED integer RPM 5 15


PRODUCT milli-
6 LEVELLING
integer second 0 5000

7 BATCH string 1 40 characters

BLEND REVERSE TIME


= time interval for change of sense of rotation ("0" if no reversion of rotation is required),
BLEND SPEED = RPM of supporting arm
LEVELLING =Product levelling time value, "evenly equalized product surface within the container".
Depending on its fluidity, the surface of the product within the container will be more or less inclined
after rotation stops at vertical position. This results in an unbalance of the container and may perturb
weighing sequences or can even be dangerous during e.g. transport by a fork lifter. Therefore, at the
end of blending sequence can overrun the vertical position, during the preset time (e.g. 2000 rns). After
the preset time has elapsed the blender rotates back to vertical position to enable equal distribution of
products surface. Depending on products flow ability, levelling angle can be programmed between:
1000 ms and 5000 ms.
SE=tVOLiFT
Software Design Specification (50S)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Ita evi - Sao Paulo, Brazil Customer Reference 4500233630

I Date of Version: 123. Dec 2015 1 Version: 1

4.4. Recorded data


For creating a printout the following data are recorded.
The printout function can be started automatically or manually with adjustable function button.

Logging of blending process (as described in FS/FDS, section "Printout"):

( - Servolift device identification (project I machine number)


- product name
- product number
- batch number
- pre-selected blend time
- elapsed blend time
- blend speed
- reverse time (chanqinq direction of rotation)
- blending start date
- blendinq start time
- blending stop date
- blending stop time
- user name blendinq start
- blending status:
0 blend finished
0 blend interrupted by operator
0 blend interrupted by disturbance
( - alarms

See an example of blend report on next page:

13565_SDS_1_E.docx 50 I
58
/1 ,_'.. _ .;,. ""':.

Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratorlos SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 I Version: 1

4.4.1. Example for batch report protocol

This is an example of a blend report protocol with assignment of each parameter according to
previous page. Here selected operating language is ENGLISH, but it can also printed in
PORTUGUESE language, if it was changed by key with flag in MAIN MENU:

( CONTAINER BLENDER 13565 SE=lVOLiFT


BATCH REPORT
BATCH:

RfCIP~:
PRODUCl NAr'IE: PRUDUCT
NUMBER: PROOUc:r
lEVr.llING [~ISJ o MS

PRrSET: AcnJAL:
DlEND TIIIE (~IINl
BLEND REVliRSE TI~IE [~lIN]
o : 00
~lIN 0 : 00 NIN
0: 00 MIN
ULEND SPEeD [RPM] 00 RPM
BLEND STIIRTED: 01/01/199912,00:00
BLEND STOPPED: 01/01/199912:00:00
BLEIID STIITE: BUND NOT STARTID

OP:RIITOR:

DAlE SIGNATURE

RENARK:

ALARM
NO.1 nH STATE DATE

This area is only filled


if the running sequence
is interrupted by
disturbance or
malfunction. It will be
given here in clear text.

PAGE: 1
FRUIT DATE: 10/06/1015
07:15,51

13565_SDS_1_E.docx 51 /
58
SE=tVOLiFT
i ,::;~.,::':..

Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Itapevi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 I Version: 1

5. PLC Module Description


This section provides a top-level view of the design process of the machine's control system.
The control system is structured in a modular manner. Every single module is composed of a
group of functions. Any modifications can be implemented in the module itself. The software
development will comply with GAMP regulations. The standard operating procedure (SOP)
( describes the procedure for development of software.

It contains the following items:

using of defined modules


module identification (name, function, version number)
documentation of complete finished program
verification of inputs, determination of limit ranges (e.g. for inputs of values)
removal of not used modules and function modules
evaluation of cross-references
clear definitions for fault messages
functional and operational check of complete machine at the supplier,
documentation of all tests as per acceptance criteria

(
SE=tVOLiFT
Software Design Specification (50S)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma l.aboratcrios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1Version: 1

5.1. OB functional description

5.1.1. OB1 (STANDARD MAIN OB)- MAIN PROGRAM


The OB 1 is a standard S7 Siemens organisational block, which is processed every cycle to control
the operation of the program. This has to be included in the program. This block will
( unconditionally call the main blocks which will form the main body of the program.

5.1.2. OB100 _ PLC FIRST CYCLE


The OB100 is a standard S7 Siemens organisational block, which is only for one time processed
when the CPU is instructed to carry out a complete restart. This will cover the conditions of a CPU
power cycle condition or a transition from CPU stop to run mode. The code within this block will
ensure that the system is started up in a defined state which dependents upon the system status
before it were stopped.

5.2. FB functional description

5.2.1. FB11 _ CLAMP


This block checks the machine's necessary hand functions and the conditions for the manual
control so that the corresponding functions can be executed in manual and maintenance mode.

5.2.2. FB12 _ LIFT


This block checks the machine's necessary hand functions and the conditions for the manual
control so that the corresponding functions can be executed in manual and maintenance mode.

5.2.3. FB16 - TURN


This block checks the machine's necessary hand functions and the conditions for the manual
control so that the corresponding functions can be executed in manual and maintenance mode.

5.2.4. FB60 _ AUTO CLAMP


This block manages the clamping function, also the monitoring of clamp pressure.

5.2.5. FB64 _ FNCT BLEND


This block check's the necessary start conditions and then manages the blending cycle.

5.2.6. FB65 _ REVERSE TIME EVALUATION


This block manages the change of direction of rotation during the blend cycle
in accordance to selected time value entered directly at the HMI by the operator.

5.2.7. FB69 _ BLEND TIME EVALUATION


This block manages the evaluation of blend time.
SE=iVOLiFT
~...' - .';{;(-.<.;",.

Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evl - Sao Paulo, Brazil

I Date of Version: 123. Dec 2015 1Version: 1

5.2.B. FBB1 _ WORKING HOURS


This block evaluates the working time of the single motor driven devices.
The values will be stored separately in a data block and can be reset separately.

5.2.9. FBB5 _ FNCT SPEED CALIBRATION


(
This block manages the calibration of blend speed.
It has interfaces with the blocks FBB? and FB9?

5.2.10. FBB? _ SPEED CORRECTION


This block is used to manage the calibration of blend speed
at the complete range of blend speed.

5.2.11. FB90 _ SERVICE INTERVAL


This block manages the indication of service intervals.

5.2.12. FB92 _ ADVICE MESSAGES


This block determines the advice messages of the HMI screens.

5.2.13. FB9? _ ACTUAL SPEED CORRECTION


This block manages the correction of indicated blend speed at the HMI.

5.2.14. FB99 _ DISTURBANCE MANAGEMENT


This block manages the start-up and the alarm handling of the system. Each alarm will be
checked. If there is a fault the corresponding flag will be operated, which activates the message.
(
5.2.15. FB1 00 _ OUTPUTS
This block evaluates the digital outputs.

5.3. Fe functional description


..
5.3.1. FC5 _ IN/OUT STATE INDICATION
This block manages the access of connected pic with status force. Status force allows to monitor
operations of the PLC program, etc. It is not necessary to connect an additional programming
device or additional PC to the PLC. This function will be executed directly at HMI-terminal.

5.3.2. FC101 _ AO BLEND SPEED / ANALOG OUTPUT BLENDING (PAW)


This block manages the transfer of analog value to analogue output

13565_SDS_1_E.docx 54 /
58
5E~VOLiFT
I:. i " ,.-'.;.'" I

Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

6. Glossary
The following is a list of terms used throughout this document:

FDS --------------.---- Functional Design Specification


FS --------------------- Functional Specification
( HDS -------------------- Hardware Design Specification
HMI _--------------------- Human Machine Interface
MPI ----------------------- Multi Point Interface
N/C ------------------_ ..._ ..._ ..- Normally Closed
N/O ----------------------- Normally Opened
PLC ------------------------ Programmable Logic Controller
SDS ---------------------- Software Design Specification
URS ------------------------ User Requirement Specification
USB ----------------------- Universal Serial Bus

13565_SDS_1_E.docx 55 /
58
SE=iVOLiFT
[ii'u i ;1. .. .;.
,t';......:
Software Design Specification (SDS)
Type of Machine: I Container Blender J Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 123.Dec 2015 1 Version: 1

Attachments
7.1. PLC Structure

This scheme shows graphically the described and used modules which form the complete pic program,
given as table in section "Siemens S7 PLC Program Blocks Listing".

.... 13565
.....::;:dd~~;.;d~.::i~~.......................... ~ ..................................

it Devices So networks
II !.I Asem Ubiquity (CPU 414-3 PNJDP)
.... rI CPU 313C (CPU 313C)
Y De'. ICe configura tion
~~.Online Sc diagnostics
.... ~ Prcgra III blocks
.;. Add new block
ORGr.NlSr.ll0N [OB 1 J
PLC FIRSTCYCLE(OBtOOI

..
DB ','.oRKltIGHOUI\S ioBSI J - 1

..
'1:: auto
t:: Hr.U
- 2
3

..
t:: 1\4anual 4
i:: outputs
.. '1:: service
-interve I
5

Find on next page(s) the detailed information of enlarged modules "AUTO"; "HMI"; "Iift_encoder";
"MANUAL"; "OUTPUTS" and "SERVICE INTERVAL", which form the complete pic program.

13565_SDS_1_E.docx 56 /
58
," ,. _ .. ," ....

Software Design Specification (SDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma t.aboratorios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 123. Dec 2015 1 Version: 1

item enlarged module description


1 ... 't:: auto
.. AUTO CLAMP jFB60) Here find the detailed information of
.. DB AUTO CLAMP IDB60) module "AUTO" with included modules for
.. t: blend "BLEND" and "CALIBRATION" functions .
.. BLEND 11ME EVAlUAll0N !FB69)
( .. FNCTBLEI~D IFB6.;)
.. REVERSE llME EVALU.:"1l0N !FB65]

DB FNCTBLEND JDB6")
.. DB RECIPE ACTUAL (DB67)

DB RECIPE COMtlilON IDB6S]


.. DB RECIPE SET!DB66)
.. i:: calibration
.. ACTUAl SPEED CORRECllOI~ iFB97)
.. FNCTSPEED U.LIBRA1l0N IFBS;;)
.. SPEED CORRECllON fFeB7]
DB FNCT SPEED CALIBRA110N {DBS5]
DB SPEED fDBSS]
III DB SPEED CORRECTION IDB89]

2 ... i:: HMI


.. INIOUTST.';TE INDIC.'1110N iFCS] Here find the detailed information of
.. ADVICE MESS.:"GES (FB92] module "HMI" with used FCs and FBs .
.. DISTURB.:..rKE M:..r~AGEMENTFB99]
.. \\ORKII>JG HOURS jFBS 1]
.. CMD fDBI)

CMD_POS iDB2)
.. COMMON iDB3)
.. DB ADVICE MESSAGES (DB9::1]
.. DB DISTURBANCE (DB99)
III DB DISTURBANCE MANAGEtl.tENTjDB98)

DB HI\I SE711~IGS (DB9)


.. DB LlFTENCODERIDB1Sl)
DB SETilNGS M..;IIHEN ...N. CE COl\IIYION
(08180]
If DB SEiTINGS M';INTENANCE SlEW!DBI82)
.. DB SETllNGS SUPERVISOR JDB190]
.. DB SlEWENCODER !DBl B5)
III DB STF.TE INDIU.110N lOSS]

list will be continued on next page with item 3 - 5


SE=JVOLiFT
i':'~~i.;;:~;.. ':,,'

Software Design Specification (SDS)


Type of Machine: I Container Blender I Servolift Project No. 13565

1
Eurofarma Laboratories SA,
Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 123. Dec 2015 1Version: 1

list is continued from previous page ...

item enlarged module description


3 ..... Manual
.. CL.AMPiFBlll Here find the detailed information of module
.. HEIGHT_STOP IfBBJ
"MANUAL" with used FBs .
... LlFTfFB1-"J
.. TURrI iFB161
.. W,LVE ifBI.;J
.. DB CLAMP {oStlJ
.. DB HEIGHTSlOP IDBB}
.. DB LlFTiDBU}
.. DB TURN [DBt6J
.. DB VALVE{DBH}

4 ...............~....~.~?~~p.~~~
.. Here find the detailed information of module
.. i-.O BLEND SPEED IFCtOl] "OUTPUTS",
.. OUTPUTS iFB10D]
DB OUTPUTS 106100)

5 :::::::::::::::::::::::~;:::~:~~~~)~i~:~:~C::::::::::::::::::::::::::::::::::::::::::::::::
.. SERVICE_INTERVAL !FB90] Here find the detailed information of module
DB SERVICE INTERVAL {DB90I "SERVICE INTERVAL" .

7.2. Operational Sequences


Find description in separate document, see "13565_FS/FDS", current version, section 6"

- END of document -

13565_SDS_1_E.docx 58 /
58
SE=iVOLiFT
HOS 1/0 List
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratorlos SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 121. Dec 2015 1 Version: 1

HOS - 1/0 List


for
Container Blender

Eurofarma Laboratorios S.A.,


Itapevi - Sao Paulo,
Brazil

Supplier Name / Signature Position Date

Mr. R. ~hri.llger/ ,
Electrical
Written by:
Sig:
.~ /I./~, programming dept.
21. Dec. 2015

Ms. M'f1ttkro~ Electrical


Reviewed by: 21. Dec. 2015
Sig: l 0 ~f... editorial dept.
Mr. C. ,H,arms
Asst. manager
Approved by: (/" ~tA,'{./\ electrical dept. 21. Dec. 2015
Sig: / c-:

Customer Name / Signature Position Date

Reviewed by:
Sig:

Reviewed by:
Sig:

Approved by:
Sig:

13565_HDS-IO_1_E.docx 1 110
SE=1VOLiFT
HOS 1/0 List

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

I Date of Version: 121 . Dec 2015 1 Version: 1

Version control - Change history - Change control

this page will be revised each time the specification is revised and re-issued, to record the dates and
reason for issue. All changes of this document (either for review or approval) are registered in this list.

Change Date Editor Reason for Change

1 21. Dec 2015 BR initial version

13565_HDS-IO_1_E.docx 2/
10
5E=iVOLiFT
:;'; s, r; ;/" ;' .:':,))

HOS 1/0 List

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratonos SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

I Date of Version: 121. Dec 2015 1Version:

1 table of Contents

1. General Introduction 4
1.1. Author I Authority 4
1.2. Purpose and Method of Use 4
1.3. Reference Document(s} 4

2. Digital Inputs 5
2.1. module 15A2 (Byte 124, 125, 126) 5
2.2. module 15A7 (Byte 0, 1) 6
2.3. module 15A8 (Byte 4, 5) 7

3. Digital Outputs 8
3.1. module 15A2 (Byte 124, 125} 8
3.2. module 15A7 (Byte 0, 1) 9

4. Analogue Inputs 10
4.1. module 15A2 (PEW 752 - PEW 760) 10

5. Analogue Outputs 10
5.1. module 15A2 (PAW 752 - PAW 754) 10

13565_HDS-IO_1_E.docx 3/
10
SE=iVOLiFT
HOS 1/0 List

Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 121. Dec 2015 1Version: 1

1. General Introduction
1.1. Author I Authority
This document is the I/O List as additional document to the Hardware Design Specification (HDS).
It presents the assignment of sensors and actuators to the pic cards and it is the basis
for programming and assigning the visualization of the HMI-terminal which is used for control of
the blender. This document is written and approved by SERVOLIFT GmbH, Germany.

1.2. Purpose and Method of Use


The purpose of this I/O List is to give an overview of the used in- and outputs of pic components
in correspondence with the electrical schematics which are needed for control of the machine,
and in preparation the test protocols to check the correct functionality as described by the
contract.

1.3. Reference Document(s)

Document Version (current indices)

Functional Specification 13565_FS-FDS

Drawing Blender 13565-00-001


Hardware Design Specification HDS 13565_HDS

13565_HDS-IO _1_ E.docx 4/


10
SE=iVOLiFT
HDS-1/0 List
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

1Date of Version: 121.Dec2015 1Version: 1

2. Digital Inputs
PLC and periphery modules are installed in electric cabinet.

2.1. module 15A2 (Byte 124,125,126)


SIGNAL SIGNAL
LABELLINGI
DATA OK NOT OK
address function text REFERENCE
TYPE "normal "normal
ESCHEME mode" mode"
1124 .0 SPARE BOOl
.1 SPARE BOOl
.2 SPARE BOOl
.3 FREQUENCY REACHED TO OPEN BRAKE BLENDER BOOl 3U3 TRUE FALSE
.4 FREQUENCY CONVERTER: FAULT = lOW BOOl 3U3 TRUE FALSE
.5 SPARE BOOl
.6 POSITION OF SUPPORTING ARM BOOl 20B11 TRUE FALSE
.7 SPARE BOOl
1125 .0 ESTOP MODULE OK 1 BOOl 10A1/PIN 18 TRUE FALSE
.1 E-STOP MODULE OK 2 BOOl 10A1/PIN 20 TRUE FALSE
.2 E-STOP 1 PRESSED =LOW BOOl 10S6 TRUE FALSE
(
.3 E-STOP 2 PRESSED =lOW BOOl (SPARE) TRUE FALSE
SIGNAL
.4 SAFETY DOOR CLOSED BOOl EXCHANGE TRUE FALSE
S4 32
.5 SPARE BOOl
.6 SPARE BOOl
.7 SPARE BOOl
1126 .0 TEMPERATURE HYDRAULIC Oil >70 =lOW 0
BOOl SS3 TRUE FALSE
.1 SPARE BOOl
.2 SPARE BOOl
2F6,2F7,
.3 FUSE/ OVERLOAD RELAY SWITCHED OFF =lOW BOOl 1F6,3F3, TRUE FALSE
1QS, SQ3
.4 POWER CIRCUIT BREAKER HYDRAULIC PUMP BOOl SK11 TRUE FALSE
.5 FUSE 24V DC GENERAL SWITCHED OFF = lOW BOOl 2F3 TRUE FALSE
.6 SPARE BOOl
.7 SPARE BOOl

13565_HDS-IO _1_ E.docx 5/


10
SE=lVOLiFT
HOS I/O List

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

I Date of Version: 121 . Dec 2015 1 Version: 1

2.2. module 15A7 (Byte 0,1)


SIGNAL SIGNAL
LABELLINGI
DATA OK NOT OK
address function text REFERENCE
TYPE "normal "normal
ESCHEME
mode" mode"
10 .0 TURN POSITION 0 = HIGH BOOl 2382 TRUE FALSE
.1 TURN POSITION 0 = lOW BOOl 2382 TRUE FALSE
.2 SPARE BOOl
.3 SPARE BOOl
.4 PICK-UP HEIGHT CONTAINER BIG BOOl 2388 TRUE FALSE
.5 MIN. HEIGHT BOOl 23810 TRUE FALSE
.6 MAX. HEIGHT BOOl 23811 TRUE FALSE
.7 SPARE BOOl
11 .0 SPARE BOOl 5S3 TRUE FALSE
.1 SPARE BOOL
.2 TEMPERATURE CONTACT 8lEND MOTOR 1 BOOl 4S3 TRUE FALSE
.3 SPARE BOOl
( .4 SPARE BOOl
.5 SPARE BOOl
.6 SPARE BOOl
.7 E-STOP MODULE READY BOOl 10A1/PIN 26 TRUE FALSE

13565_HDS-IO _1_ E.docx 6/


10
SE=lVOLiFT
HOS -1/0 List

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

I Date of Version: 121. Dec 2015 1 Version: 1

2.3. module 15A8 (Byte 4,5)


SIGNAL SIGNAL
LABELLINGI
DATA OK NOT OK
addres function text REFERENCE
TYPE "normal "normal
ESCHEME
( mode" mode"
14 .0 CONTAINER IN POSITION BOOl 27B2 TRUE FALSE
.1 CONTAINER CLAMPED lOW RESET VALUE BOOl 27B4 TRUE FALSE
CONTAINER CLAMPED HIGH RESET VALUE
.2 BOOl 27B4 TRUE FALSE
(REClAMP)
.3 SWIVEL CLAMPS RETRACTED (CLAMPED) BOOl 99B2,99B5 TRUE FALSE
.4 SWIVEL CLAMPS EXTENDED (UNClAMPED) BOOl 99B8,99B11 TRUE FALSE
.5 CONTAINER CENTERING PRESSURE OK BOOl 27B10 TRUE FALSE
.6 CENTERCYl.RETRACTED BOOl 27B11,27B12 TRUE FALSE
.7 CENTERCYl.EXTENDED BOOl 27B13,27B14 TRUE FALSE
15 .0 SPARE BOOl
.1 SPARE BOOl
.2 SPARE BOOl
.3 SPARE BOOl
.4 SPARE BOOl
(
.5 SPARE BOOl
.6 SPARE BOOl
.7 SPARE BOOl

13565_HDS-IO _1_ E.docx 7/


10
5E~VOLiFT
HDS 1/0 List

Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

1 Date of Version: 121. Dec 2015 1 Version: 1

3. Digital Outputs

3.1. module 15A2(Byte 124,125)


SIGNAL SIGNAL
DATA LABELLINGI OK NOT OK
address function text REFERENCE
TYPE "normal "normal
ESCHEME
mode" mode"
0124 .0 FREQUENCY CONVERTER START BLENDER BOOl 3U3 TRUE FALSE
.1 FREQUENCY CONVERTER REVERSE BLENDER BOOl 3U3 TRUE FALSE
.2 FREQUENCY CONVERTER JOG SPEED BLENDER BOOl 3U3 TRUE FALSE
.3 FREQUENCY CONVERTER QUICK STOP BLENDER BOOl 3U3 TRUE FALSE
.4 ROTATION COUNTER BOOl 30P8 TRUE FALSE
.5 RESET E-STOP MODULE BOOl 10A1 TRUE FALSE
.6 OPEN BRAKE BLENDER BOOl 309 BY 3K12 TRUE FALSE
.7 FREQUENCY CONVERTER BLEND DRIVE ON BOOl 3U3 TRUE FALSE
95Y2
0125 .0 H*-VAlVE: CLAMP BOOl BY 31K2 TRUE FALSE
95Y4
.1 H-VAlVE: UNCLAMP BOOl BY 31K4 TRUE FALSE
95Y5
.2 H-VAlVE: EXTEND CENTER CYL. BOOl BY 31K5 TRUE FALSE
95Y7
.3 H-VALVE: RETRACT CENTER CYL. BOOl BY 31K7 TRUE FALSE
95Y8
.4 H-VAlVE: LIFT BOOl BY 31K8 TRUE FALSE
95Y10
.5 H-VAlVE: lOWER BOOl BY 31K10 TRUE FALSE
5M3
.6 MOTOR HYDRAULIC PUMP ON BOOl BY 31K11 TRUE FALSE
96Y4
.7 H-VAlVE: RELEASE FUNCTION CLAMP BOOl BY 31K13 TRUE FALSE
H*-VAlVE: means hydraulic valve

13565_HDS-IO _1_ E.docx 8/


10
5E=iVOLiFT
HOS - 1/0 List

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

I Date of Version: 121. Dec 2015 1 Version: 1

3.2. module 15A7 (Byte 0,1)


SIGNAL SIGNAL
DATA LABELLINGI OK NOT OK
address function text TYPE REFERENCE "normal "normal
ESCHEME mode" mode"
(
00 .0 BLEND ISRUNNING BOOl 32K2
.1 SPARE BOOl
.2 SPARE BOOL
.3 SPARE BOOl
.4 SPARE BOOl
.5 SPARE BOOl
.6 SPARE BOOl
.7 SPARE BOOl
01 .0 SPARE BOOL
.1 SPARE BOOl
.2 SPARE BOOL
.3 SPARE BOOl
.4 SPARE BOOl
.5 SPARE BOOl
"\
.6 SPARE BOOl
.7 SPARE BOOl
5E=1VOLiFT
H OS - 1/0 List
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Itapevi - Sao Paulo, Brazil

I Date of Version: 121. Dec 2015 1 Version: 1

4. Analogue Inputs

4.1. module 15A2 (PEW 752 - PEW 760)


SIGNAL SIGNAL
LABELLINGI
address function text DATA OK NOT OK
REFERENCE
TYPE "normal "normal
ESCHEME
mode" mode"
PEW 752 SPARE INT
O <0
754 CLAMP PRESSURE INT 2784
27648" > 27648
756 SPARE INT
758 SPARE INT
760 SPARE INT

5. Analogue Outputs

5.1. module 15A2 (PAW 752 - PAW 754)


SIGNAL SIGNAL
LABELLINGI
address function text DATA OK NOT OK
REFERENCE
TYPE "normal "normal
ESCHEME
( mode" mode"
0- <0
PAW 752 ANALOG OUTPUT VALUE: BLEND SPEED WORD 3U3
27648" > 27648
754 SPARE WORD
corresponds to 4-20mA at analogue Input of frequency converter

- END of document -

13565_HDSIO_1_E.docx 10/10
SE=iVOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servollft Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evl - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 I Version: 1

HARDWARE DESIGN SPECIFICATION


.' for
\
Container Blender

Eurofarma Laboratorios S.A.,


Itapevi - Sao Paulo,
Brazil

Supplier Name / Signature Position Date

y
Mr. R. ~hri.~er~ ,
Electrical
Written by:
Sig:
/4. programming dept.
22. Dec. 2015

Ms. M'ffttkrc~ Electrical


Reviewed by: 22. Dec. 2015
Sig: t 0 ~f... editorial dept.

( Mr. C. .Harms
Asst. manager
Approved by:
Sig:
fi l'4_" t,
V' electrical dept.
22. Dec. 2015
/

Customer Name / Signature Position Date

Reviewed by:
Slg:

Reviewed by:
Sig:

Approved by:
Sig:

13565_HDS_1_E.docx 1/
49
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 1 Version: 1

Version control - Change history - Change control

This page will be revised each time the specification is revised and re-issued, to record the dates and
reason for issue. All changes of this document (either for review or approval) are registered in this list.

Change Date Editor Reason for Change

1 22. Dec 2015 BR initial version


Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 122. Dec 2015 1 Version: 1

Table of Contents

1. General Introduction 4
1.1. Author I Authority 4
1.2. Purpose and Method of Use 4
1.3. Contractual Status 4
1.4. Reference Document(s) 4

2. Overview 5
2.1. Intended Use of the Machine 5
2.2. System Components 5
2.3. Machine overview 6
2.4. General control system 8

3- Control System 9
3.1. Main Control System Components 9
3.2. Storage and retentivity of memory 12
3.3. Peripherals 13
3.4. Interconnections 37
3.5. Configuration 40
(
4. Inputs & Outputs 41
4.1. Digitallnputs 41
4.2. Digital Outputs 44
4.3. Analogue In-/Outputs 45
4.4. I/O Listing 46

5. Environment 46

6. Electrical Supplies 47
6.1. Filtering 47
"

6.2. Loading 47
6.3. Earthing protection 47
6.4. Uninterruptible power supply (UPS) 47

7. Glossary 48
7.1. Definitions 48

8. Attachments 49
5E~VOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 1 Version: 1

1. General Introduction

1.1. Author I Authority


This document is the Hardware Design Specification (HDS) and it is part of the complete
documentation package for the machine. It is used to describe the used hardware of the several
control devices for the Blender.
This document is written and approved by SERVOLIFT GmbH, Germany.

1.2. Purpose and Method of Use


The purpose of this document is to clearly define the main hardware components and interfaces
to other systems, if part of the contract and needed for the functionality. This document will cover
a wide range of hardware aspects of the machine and control sequence(s).
It is intended that it should be returned marked up as approved. Each time it is issued, it will be
given a new revision number, which can be read in head line and is referred by the file name.
When the final specification is approved, it will be used as the basis for installing and testing.

1.3. Contractual Status


This document is an integral part of the documentation to be supplied under the contract.
For change control the current revision status is indicated at the head line on each page.
It will be used as a reference for writing the factory acceptance test documents (FAT),
the installation qualification / operational qualification (10/00) test documents, which the machine
will be tested against.

/ The blender will be designed and manufactured to conform to the following standards:
!
GAMP Guidelines (current version)
all components will be CE certified

1.4. Reference Document(s)

Document Version (current indices)

Functional Specification 13565_FS-FDS


Drawing Blender 13565-00-001
SE~VOLiFT
: ;;t:~'i,-,(.;' ";!~,. ;'1..-: ,"

Hardware Design Specification (HDS)


Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 122. Dec 2015 1 Version: 1

2. Overview
2.1. Intended Use of the Machine
The blender is exclusively destined to take the descript containers with a maximum load of 1000
kg and to blend them.
Operation is done on a separate operating terminal as touch display. The controls are located at
a separate stainless steel control cabinet. The danger zone is protected by customer with safe
potential free contacts on process site door switch.
The machine is not designed for any other use than that listed above. For all for injury to persons
and damage to property which occur from inappropriate use, the liability is only subject to the user
off the machine and not to the manufacturer.

2.2. System Components


The machine is stationary and bolted to the floor.
Lifting is powered by a hydraulic cylinder located into the machine.
A carriage inside the column is moved up and down along a guideway.
The machine is mounted on a plate.
The blend drive with the pick-up arm are fixed to the carriage inside the column.
The pick-up arm supports the load.
Clamping is motorised.
The functions are operated on a separate operator panel.
( Blending is only possible if the danger zone is protected.

[extracts of current version of FS-FDS]


5E~VOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 1 Version: 1

2.3. Machine overview


This scheme shows the machine and its components in brief. It indicates also the design
of operator interface, means operator panel and its location towards the machine.

operator panel, wall mounted,


it contains following devices:
the HMI-terminal,
an emergency stop
and behind the cover an printer

Find on next page the "top view" of the machine.

13565_HDS_1_E.docx 6/
49
SE=iVOLiFT
-.', a ,' ._to, ~ ,;

Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. 13565

I
Eurofarma Laborat6rios SA,
Customer: Ita evi - Sao Paulo, Brazil Customer Reference 4500233630

1 Date of Version: 122. Dec 2015 I Version: 1

2.3.1. top view

"-. Xl

\ electric cabinet
including the pic and
periphery,
on front side the main
switch is installed for
general power supply of
the blender

ROOl"I06S

operator panel which


contains the HMI,
the emergency stop
push button
and the printer

13565_HDS_1_E.docx 7/
49
SE=tVOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 1Version: 1

2.4. General control system


The system will be equipped by basic hardware devices shown in the diagram below.

The main hardware is built up on a Siemens PLC type 300 and a Siemens touch panel HMI type
( "TP1200 comfort" as operator interface. Communication between HMI and PLC is done via
Siemens MPI protocol.

2.4.1. Device view


This overview shows the used pic and its components:

Rack 0 HMI

2.4.2. Network view


This overview shows the interface connections, here MPI:

CPU 313C SIMATICHMI


CPU 313C TP1200 Comiort

~MPI_1

13565_HDS_1_E.docx 8/
49
SE=-1VOLiFT
: I ~ -', ~: '1 r- :,;

Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 I Version: 1

3. Control System
In the following the most important used hardware components are described.

3.1. Main Control System Components


This section describes the configuration of the main control system components:

3.1.1. PLC
The machine is controlled by a PLC, type SIEMENS S7-300 CPU 313C.
It is installed in the electric cabinet onto corresponding DIN rail.

Manufacturer Siemens

Model S7-300, CPU 313C 1613950


Ref. e-schematics 15A2

Specification

general description:
SIMATIC S7-300, CPU 313C,
COMPACT CPU WITH MPI,
2401116 DO, 4AI, 2AO 1
( design
PT100, 3 FAST COUNTERS
(30 KHZ), INTEGRATED 24V
DC POWER SUPPLY, 128
KBYTE WORKING MEMORY

power supply 24V DC, permissible range: 19,2V to 28,8V

current
in no-load operation: typo 150mA rated value: 650mA
consumption

inrush current typically 5A

power loss typically 12W

interfaces 1x RS485 (=> MPI), transmission speed: 187.5 kbitls

S7 communication as server: Yes 1 as client: Yes, via CP and loadable FB

memory card (15A2) S7-300 MMC 64k, type 700-953-8LF30 (613951)


see datasheet "DB CPU313C E.pdf', found in section "Attachments"

13565_HDS_1_E.docx 9/
49
SE=iVOLiFT
.." . ;.1:.;.>' . t:l

Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 122. Dec 2015 1 Version: 1

3.1.1 .1. Memory concept


The CPU consists of three memory areas:

Specification
",

.................... ~
..
"
... r

.. , ioid memory - '-li'~ 11


.
CPU ...... (located on SIMA nc
..[<: [ .
.r .'j l~:~~~~
~I_cro Memory Card). .. . . :> <)

design

[j' . System memory


1-' _.- -_.- -. -- --

Main memory
_.... ._-- _. -

....

The load memory is located on the SIMATIC Micro Memory Card


(MMC). The size of the load memory corresponds exactly to the
size of the SIMATIC Micro Memory Card. It is used to store code
blocks, data blocks and system data (configuration, connections,
module parameters, etc.). Blocks that are identified as not relevant
Load memory for the execution are stored exclusively in the load memory.
It is also possibly to store all the configuration data for the project
on the Micro Memory Card.

Note: The Micro Memory Card must have inserted into the CPU to
enable the download of user programs and operation of the CPU.
( The RAM system memory is integrated in the CPU and cannot be
expanded.
It contains
System memory the address areas for address area memory bits,
timers and counters
the process image of the II0s
local data
The work memory is integrated in the CPU and cannot be extended.
Work memory It is used to run the code and process user program data.
Programs only run in the work memory and system memory.

13565_HDS_1_E.docx 10 I 49
SE=tVOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

3.1.1.2. Communication functions

Specification

MPI multi-point interface;


(
the integrated MPI interface can establish as many as 8 connections
simultaneously to S7-300/400 or to the PG, PC, OP. Among these
features
connections, one is always reserved for programming devices and
another for OPs. The MPI makes it possible to set up a simple
network with a maximum of 16 CPUs via "global data communication"

PG/OP communication

integrated functions
Global data communication
S7 basic communication
S7 communication (server only)
[excerpt from siemens.corn website]

3.1.1.3. Clock

Specification
----------- ------------ -- -- ---_-
Clock

Hardware clock (real-tlme clock) Ves


--b:-.-Ue-ry-.b-ac-k-ed-g-nd-s-yn-c-hr-on-iz"":'ab-Ie---- Yes

( D_e_vl_at_ion_pd__e._yr ._m_ax_, 10.: Typ,: 2 s


aackup time e wk : At 40 'C ambient temperature
aehe'lior 01 the clock (ollowing POWERON Clock continues running after POWER OFF

Behavior 01 the clock following expiry 01 backup Clock continues to run with the time at which the power
period fal1ur6 occurred
- ----------------- ---------- ----
Operating hours counter

Number
features NumberiNumber range

R_._ng:....e_o_'v_al_ue_s 0 to 2"31 hours (when using SFC 101)

-- - - Granularity 1 hour
Yes ; Must be restarted at each restart

------------
re tent ive

----------~------------------- ---- ----- --


Clock synch,onlzaUon

s_u;._pp_ort_e_d Yes

t_o_M_PIm_,_a_.t_e' Ve~

to MPI, slave Ves


--I-n A-S:-,-m-as-te----------- Ves

In AS, slave No

[excerpt from siemens.com website)

13565_HDS_1_E,docx 11 /49
",
v
.

Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 I Version: 1

3.2. Storage and retentivity of memory

3.2.1. PLC Memory


The PLC will be equipped with a maintenance-free retentive memory, Le., its operation does
( not require a buffer battery. Data will be kept in retentive memory across POWER OFF and
restart (warm start).

Specification

retentive data. the program in load memory is always retentive: it is stored on the
Micro Memory Card, where it is protected against power failure or
in load memory
CPU memory restart
in accordance with the configuration (properties of CPU, retentivity
tab), parts of memory bits, timers and counters are kept retentive
retentive data and are to be initialized with "0" on restart (warm restart)
in system memory the diagnostics buffer, MPI address (and transmission rate) and
operating hour counter data are generally written to the retentive
memory area on the CPU
the contents of retentive DBs are always retentive at restart and
retentive data POWER ON/OFF. Retentive data blocks can be uploaded to the
in work memory work memory in accordance with the maximum limit allowed by the
work memory

3.2.2. HMI Memory


The HMI will be equipped with a maintenance-free retentive internal flash memory, i.e., its
program data does not require a buffer battery and an external memory card. Data will be kept
in retentive memory across POWER OFF and restart.

Specification

retentive data the program in load memory is always retentive: it is stored on the
in flash memory internal flash memory, where it is protected against power failure
the following data will be stored:
retentive data Archives and recipes
in external memory User management data
Data for operating system backup and restore

13565_HDS_1_E.docx 12 /
49
5E=lVOLiFT
;'....'!(,.~:;e .:,:'1 .::....: ...

Hardware Design Specification (HDS)


Type of Machine: I Container Blender J Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

! Date of Version: !22. Dec 2015 ! Version: 1

3.3. Peripherals
This section describes the configuration of the peripheral elements:

3.3.1 . Operator panel - located outside of blend area, wall mounted


(
Manufacturer Servolift / Rittal

Model self-made by SL
I
Ref. e-schematics X3

Specification

general feature remote stainless steel operator panel, wall mounted

front view:

design 2

contains following 1 HMI type TP1200-12", wide screen


2 Emergency Stop push button
operating elements 3 Printer, standard DIN-A4 format, behind door
. . protection: IP65
details of housing material: stainless steel 1.4301
[excerpt from e-schematics)

13565_HDS_1_E.docx 13 /
49
SE=iVOLiFT
~;'\ I... ~,~.: ,. ; f'

Hardware Design Specification (HDS)

Type of Machine: 1Container Blender 1Servo lift Project No. 1 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

3.3.1.1. HMI
To operate the machine an operator terminal type "SIEMENS TP1200 COMFORT" with touch
screen is installed in the operator panel. The operating application is running
( on a Windows CE 6.0 operating system. The connection between PLC and HMI is done via MPI.

Manufacturer Siemens
Model TP1200, 12" Comfort 1615279
Ref. e-schematics 17A3

Specification

front and side view

bottom view
(1) X80 power supply connector
(2) Connection for equipotential bonding (ground)
(3) X2 PROFIBUS (Sub-D RS422/485)
(4) X61 1 X62 USB type A
(5) X1 PROFINET (LAN), 10/100 Mb
(6) X90 Audio Line IN lOUT
(7) X60 USB type Mini B

operating system Windows CE 6.0

memory Siemens verified Secure Digital (SO) memory card 512MB

configuration software SIMATIC WinCC Advanced V13.0

see datasheet "DB TP1200 12 E", found in section "Attachments"

13565_HDS_1_E.docx 14 /
49
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Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 I Version: 1

3.3.1.2. Printer

Manufacturer Brother

Model HL-2250-DN 1615138


Ref. e-schematics 17A10

Specification

function: printing batch reports


design
connection to HMI: USB interface

paper capacity up to 250 pages (80g/m2)


[excerpt from datasheet]
Hardware Design Specification (HDS)

Type of Machine: \ Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

3.3.2. General Components

The following section shows the general components installed in the electrical cabinet
which will be needed to enable the control of the blender:

3.3.2.1. Main switch in electric cabinet

The main power supply is switched ON by a main switch, coloured red-yellow with emergency
function. This device is installed at the front of the electric cabinet. To interrupt the general power
supply this main switch has to be turned to OFF position (1 => 0).

Manufacturer Kraus & Naimer


Model KF32 T203/04 FT2 \602567
Ref. e-schematics 1Q2

Specification
example

design

current 32A
power 16 kW

mounting single hole mounting 22mm with square escutcheon plate 64x64mm

design features red-yellow with emergency stop functionality, screw terminals


[excerpt from datasheet]
SE=iVOLiFT
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Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 I Version: 1

3.3.3. Residual-current circuit breaker (RCD)

In order to prevent dangerous currents in the event of an error, a residual current circuit
breaker is used, which disconnects the main supply as a result of an error after a leakage
current of >30mA occurs.

Manufacturer Siemens

Model 5S U 1354-6KK 10 1614987


Ref. e-schematics 1Q5

Specification

e.4C
(;.(.!-
- To prevent dangerous
currents in the event of a fault
a residual-current circuit
design / function III breaker is used, which
separates the main supply

--
A~.<.t when an error occurs at a
leakage current of> 30mA.

Design type 1ns:1i'1nten~DUS


Type, oxplanaUona I ~ddltlonally I p.t!; AC 230 V. 50 I~
EOH. Design 01the faultcurrent type A
( Cvervolt.ge cloas ~
Tripping characterlltlc cle a
Mounting depth mm 70
Energy limiting claas s
!lumber of poles 2
!lumber of pitch units for width 2
Release fault-current I rated value A 003
fonctlon du prodult I neutre commutant Yes
Supply .oltege Irequency r rated value HZ 60
technical data Breaking capacity current
[nicht versorgl - nach IEC 609-17-2J I [nicht I(A IS
versergl - Bemessungswert]
ace. to EN 60898 I rated value I(A 10
Supply voltage I for AC I rated value V 210
Current I lor AC r rated varue A 10
Protection clul IP 1P20
Conductor cross-sections I mm' 0,7, t"35mm' (Solidand!lranaed); 0,751111
25mm'(Finely1Iranoeaw~n end slOeve)
Device service IIle I operatJng cycles > 10000
Terminal tightening torques 2,Slill30tlm
Storage temperature -AOblr.7S'C

[excerpt from datasheet]


5E~VOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 I Version: 1

3.3.4. Drives (blend motor, hydraulic pump, etc.)

3.3.4.1. Drive Unit 1 _ blend drive


(
Manufacturer SEW
Model SA 77 DRE 132S4 BE-11fTH 18015842
Ref. e-schematics 3M3

Specification

power 5,5kW

voltage 220/380V

frequency 60 Hz

brake no if yes, voltage: 24VDC

tem perature contact yes if yes, type 1xNC [3S3]

speed, adjustable yes range: 5 ... 15 rpm


(
freq. converter used yes if yes, type: FC302 [3U3]
SE=iVOLiFT
/' '/:'~,'!'i,,,l'~.~: ' ....

Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Ita evi - Sao Paulo, Brazil Customer Reference 4500233630

1Date of Version: 122. Dec 2015 1Version: 1

3.3.4.2. Drive Unit 2 _ hydraulic pump

Manufacturer KGenle
( Model KTE .... I 8015856
Ref. e-schernatics 5M3

Specification

power 3,OkW

voltage 220/380 V

frequency 60 Hz

brake no

temperature contact no

speed, adjustable no

freq. converter used no


/
(
The hydraulic oil temperature is monitored via oil level gauge with internal thermometer.
See further information at item "temperature sensor".
Hardware Design Specification (HDS)
Type of Machine: 1Container Blender 1Servolift Project No. 1 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

3.3.5. Frequency converter - blend drive

Manufacturer Danfoss

Model FC302 -131B0051 16902286


Ref. e-schematics 3U3

Specification
power rating 5,5kW

voltage 380-500V
frequency 50 Hz

~:i
t. ItlH\Uel it\. ,llle

PII);llIct (ilntllJ (l'C) VLTlDAu.omotionOriYo


'>0.10& (lIl"l N.tOIO~lIO"OIN~Mlnn"etl
P(lWOI Rnlh,'.) (P5K5) 5 51,W 17.5 HP
design PIo;,u (t] Th"o pn;,e
M.'lh~ Vail.'!)" (5)3IlO5Cl)VAC
[uclualll& (b.'O) IP;oo I Gh.'$,l

- RFI Fill.,
{hnk 5Mt! Sltll'
(lit) RFI OI... AtlB (e,)
(0) BlOke choppol
LCP (G) Graphical tee. Coni. Panul
("h\till'JPC:U (lO Not COBtQa PCO
M.lllI,OIdol1 (Xl No MaiM Option
A;I"pM1Iolt/\ (Xl ~tantll1d Cabl& 1:"10'"
A11.lpt.ldn .. B (X) No :adapl';lion
$,lltw",e "elt"'o t$~ UJf'1 reI UtI ';;N.

configuration details :\oftw,'le L.'iIIlJ""lJe P.lek (Xl Standard un1\ulIBo Pllck


A (lVIlOll 1N-~ No A \)pUon
regarding
B Oplillu (DX) No 8 Option
to model number 1:0111111011M(I) 1c>:J tlo (1) o,lion
C10pllnll (X) No Cl option
,; Opdoll $f)ltw;u~ (*l N~ ,oft""", .plton
o Opdl'lll (OX) No 0 cpHon
fl,llllO !.It& /IJ
l'YI)O(Olto ~C302P5K!;T5E2!JHtBGX
Tyl)"ctl\to 1".)11 :t ".<S;oc...'W(l)XCX>W.DX

The machine will have different speeds of rotation (blending):


a. the blending speed will be selectable by the operator direct at
the main operator panel
b. the positioning speed which is used at the end of the blending
usage / function cycle to rotate the container, drum etc. at a constant slow rate
to enable it to be accurately parked irrespective of the load
being handled, it is not adjustable by the operator, it is saved
inside the frequency converter (parameter listing)
SE=iVOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4S00233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 1Version: 1

3.3.S.1. Brake resistor - frequency converter - blend drive

Manufacturer Koch
( Model 2xBWDS00160 16902290

Ref. e-schematics 3R5

Specification

I.
BWD 50 0 function:
short-circuit-proof, resistor for

design '~.
~-.:r~:
ti'

~~~;::;:;~.~
'!!' I lL
operation on converters (brake
transistors)

aluminium
in an anodized

casing, protection
. ~.~
..r...i .. ~ ;?;J
- class IP65.
1IlIIIfi~' example

power 400 Watt

resistance 80 Ohm

protection class IP65


Technical data (3A = 20'C. if not indicated otherwise) .
Parameters Symbol Value Unit Conditions
Tol ... nQlO :5 '16 Amolent ttmp4fatufe

T emp'~8ture coefhd.nt TK 20 .. 100 IO~K

Inlul.llen uul5t.nOl: R!;O >= 100 MOnm tJl"It.31 1000 vee


Inductance L. <a 20 ~"i t .: !DO ttt. U,.... ~.omV
summary c.", ""-Pod,.n"" C <" 100 ~F f : 200 tH2, U..... = ~O mV
of technical details
M.e.xlmum .-dmlulbl .. .,-olt.g. U <= 700 AC V ,\11th c;oruld.e18tlon of the- Inulnsic
e 1.000 DC ufety

Inlula.tion volt'1;e U... .= .; 000 v AC. f= 60 rt:. tal min

Tempanulla of rne cese :~t ~= 2ro 'C free ocnvea.lcn

Maximum scJ-MllSible ttmp-e1'hst~ of the


wlr., H.", m"" e1)O -c

StOle~a- :i!.mpe:fat~,.. :-I, .~~ -s! -c


[excerpt from datasheet]
SE=tVOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

3.3.6. Power supply

3.3.6.1. Power supply 230V AC


(
Manufacturer Schneider J. Elektrotechnik
Model EUED 2.0B-9901 02V9 1606810
Ref. e-schematics 1T6

Specification

input: 200-500V AC
technical data output: 115/230V AC
1000VA

(
5E~VOLiFT ';) .Io~ ",
1,.[

Hardware Design Specification (HDS)

Type of Machine: 1Container Blender 1Servolift Project No. 1 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version 122. Dec 2015 1Version: 1

3.3.6.2. Power supply 24V DC /2phase

Manufacturer Riedel Michael

Model REP 2-2414 1615199


( Ref. e-schematics 2G2

Specification

output current (A) 14


design
output power (W) min. 240 I max. 330

',\'J".h"

INPlIT OA1A
". Jp\"~""",,,l.
~ 1"";;'1",1"'''''
~'1~1 J"":'.'
..S 16 ,'f"')\'

OUTPUT DATA

OCZ4V

.....;.;P.~:.;; ;'' ;.;;,,~:.;;,~.,,;;::U:;;.'' ;.;'' ;.:' 1.;;":;;.11(;.:'1:.;;4"';;";,.U':.;;I. t-:_;';;;.":.;;'";...I ,._.


(L "crl M~)I OV~ '1):11.1 ;J;:t:ru~. CC <IV lUl!ff1' 1 'I:'!}
1:,(;n.:~R- I.J!

technical data .!).l,

ClIMATIC DATA '"""1


"
1$, .10'C

~o Ii""" 'r-

.,,.,.;u.r

1,0\/.....' 1 .:-" ",,", t'k..l

I...-='~:In'J::.f~Ullil"r:

I} 10

We (,,~
SE=iVOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

3.3.6.3. Electrical slip ring unit 1 ESR 60/12

Manufacturer GAT
(
Model ESR60/12 1614607
Ref. e-schematics 27E1

Specification

design

max. rated voltage 250 V

max. rated current 4A


cable, length 3m type Olflex
D 7xO,75mm2
connection' [gj12xO,75mm2
D 18xO,75mm2

protection class IP64


[excerpt from datasheet]

13565_HDS_1_E.docx 24 /
49
5E=iVOLiFT
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Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laboratories SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

3.3.7. Safety components

3,3.7.1. E-stop module I sensor control unit

Manufacturer Elobau
(
Model 471 M41 H31 1614823
Ref. e-schematics 10A1

Specification
To ensure a safe operation of the
system, this safety module I control unit
for the use with max. 4 sensors will be
installed at the main electric cabinet.
. The condition of the device will be
design t5 monitored at all times and any change
.2 will result in a shutdown of the
equipment. In case of a system failure
or interruption of the general power
supply, the machine will stop into a safe
condition.

operating voltage 24V DC 15%

current consumption 850mA

switching switching 90VAlW


switching voltage 30VACIDC current 5/3AAC/DC power
switching switching
voltage current
max. sensor inputs 4 control 24VDC 100mA
control
output output

temp. range 0 ... +55C

indication LED
[excerpt from datasheet]

13565_HDS_1_E.docx 25 /
49
SE=-1VOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1 Date of Version: 122. Dec 2015 1 Version: 1

:l3.8. Entrance detection / Safety protection

The following safety protection component(s) is used to observe the conditions for starting any
( movement, e.g. hydraulic functions or rotation. The operational sequence is immediately stopped
in case of interruption of one of these safety components.
The blend cycle, calibration cycle or manual rotation is continued only again if the present fault is
cleared, the corresponding fault message is confirmed and reset, and the corresponding function
key is pressed again.

3.3.8.1 . Safety door (by customer)

Entrance to blender room need to be closed by a safety door with includes safety contacts which
have to be closed during blending or rotational sequence. The contacts will be hard-wired as
potential free contact (signal exchange from customer to blender's control) to the emergency stop
module. Then this module switches the release contact to continue functional sequence only if
door is correctly closed.

3.3.9. Interfaces, communication with external components, using potential free contacts
(
To handle and operate the machine in a safe manner and to prevent personal from dangerous
situations there are several feedback signals:

monltortnq blen d room access, here sa fe ty door:


supplier (SL) customer
# blender control control I signal exchange
signal "DOOR CLOSED"

signal "BLEND IS RUNNING"

13565_HDS_1_E.docx 26 /
49
5E=lVOLiFT
:";r.-:(!.~t1r-; .' /,:~J...: !".:

Hardware Design Specification (HDS)

Type of Machine: I Container Blender 1 Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 1Version: 1

3.3.10. Operating elements


Following components used in addition to the installed HMI-terminal. Following section

( describes used elements like emergency stop push button, key switches, push buttons,
indication lamps, membrane keypad, etc.

3.3.10.1. Emergency stop, unlocked by pull-release function

Manufacturer Eaton
Model M22-PV with contact elements 1613438
Ref. e-schematics 10S6

Specification

design "EMERGENCY STOP"

to shut down the equipment immediately in case of a malfunction or


disturbance during running operation, it will be hard wired through a
E-stop module / sensor control unit (as described before)
function
to comply with present legislation, the condition of E-stop module /
sensor control unit will be monitored at all times and any change will
result in a shutdown of the e ui ment
operating voltage 24VDC
[excerpt from datasheet]

13565_HDS_1_E.docx 27 /49
SE=tVOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 1Version: 1

3.3.11. Sensors (proximity switches, pressure, etc.)


Here the overview names the used sensor types and shows the most important technical data.
To read detailed information about the function, means of what function a sensor type is used,
refer to separate document called " ... HDS-IO-List", which shows function description.

3.3.11.1. Position sensor 1, "NBB5-18GM50 ..."

Manufacturer Pepperl & Fuchs

Model NBB5-18GM50-E2-V1 1601698


Ref. e-schematics 20B11,23B8,23B10, 23B11

Specification

~,
~I"'"
connection:

design
(P ~~;
~
E2
-~
I

<{l>
--. 1:BN
r'r-"--l+
) 4'BK

~f}JL'
operating voltage 10- 30V DC

switching voltage 24VDC

switching current max.200mA

tem perature range -25 ... +70C


indication
LED
of switching state

switching element PNP

protection degree IP67

operatinq distance 5mm

assured
operating distance O ... 4,05mm
installation embeddable connection type I connector M 12 x 1, 4-pin
[excerpt from datasheet]

13565_HDS_1_E.docx 28 /
49
SE=iVOLiFT
: :<. ,

Hardware Design Specification (HDS)

Type of Machine: I Container Blender 1Servolift Project No. I 13565

Eurofarma Laboratorlos SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 1Version: 1

3.3.11.2. Position sensor 2, "NBB5-18GM60 ... "

Manufacturer Pepperl & Fuchs


( Model NBBS-18GM60-A2-V1 1601690
Ref. e-schematics 23B2

Specification

~, connection:
I
- c- .
T
I
"f

V
;:>
-e

design 2.~
I ._ .~~ ~/~L' BK
~\
1'-. LEO :~
_BU L..

~
_.f-:-:--
M'2~1

operating voltage 10 _ 30V DC

switching voltage 24VDC


(
switching current 0 ... 200mA
temperature
-25 ... +70C
range
indication
LED
of switching state
switching element PNP

protection degree IP67


operating
distance Smm

assured
operating distance 0 ... 4,OSmm

installation embeddable connection type I connector M 12 x 1, 4-pin


[excerpt from datasheet]
SE=iVOLiFT
i ! '3[,/;,(; . ,. Iv;

Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories S.A.,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version; 1

3.3.11.3. Position sensor 3, " NEN20-18GM50 ... "

Manufacturer Pepperl & Fuchs

Model NEN20-18GM50-E2-V1 1614708


Ref. e-schematics 27B2

Specification
~ connection:
r+ sf I I" I
design ~-~'Fr:Er:#1t?,~: .!!
~
f ~. '~Al~;
i
---L+
I ,,12,
t ! ! BK
-~~~---
~~
IEu)fEl 1
a 11;i.~~

(4;.:) C(,
t ,
I
~H2.J. ~

operating voltage 10 _ 30V DC


C fL.

switching voltage 24VDC

switching current Max.100mA


temperature
-25 ... +70C
( range
indication
LED
o(switching state
switching element PNP

protection degree IP67

operating
distance 20mm
assured
operating distance 0 ... 16,2mm
installation embeddable connection type I connector M12 x 1, 4-pin
[excerpt from datasheet]
5E~VOLiFT
" r
: 'l ~,''::

Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

3.3.11.4. Position sensor 4, "BIM-UNT -AP7X-O,3-RS4"

Manufacturer Turck

( Model BIM-UNT -AP7X-O,3-RS4 18014762


Ref. e-schematics 27B11, 27B12,27B13, 27B14

Specification

connection:

design

\
"..
M12x I
---.-.-.- ..~
l-4B.G ._.J

Pass speOd ~ 10 m/s


Ropeatabllity >10.1 mm
Temperature drin ,0.1 mm
Hystorosis ,1 mm
Amblenttemporature 25 .. +70"C

OpOrOtlng'vollogo iO:::-3OVtjC-'-' ._
Rosldual rlpplo ,10% U.
DC rctod operatio",,1 .' 150mA
current ._ 1SmA
No-load current I. -0.1 mA
technical data Residual curront < 0.5 kV
Rated tnsutauon voltage yesl cyclic
Shortclrcull protocncn ,: 1.SV
Vollago drop ot I.
Wlro brookugo I Roverse polarity protoctlon yo:JI complete
Output function 3wlro. NO contact. PNP
Switching froquency 1 kHz

Destgn rectangutar. UNT


Dimonsions 28x5xGmm
Houslno material plastic. PP
Moteriol activo roco Plasuc, PP
Tightening torque fixing scrow 04Nm

protection class IP67

Indication by ... LED yellow, included in scope of supply => cable clip

connection type cable with connector M 12 x 1, 4-pin


[excerpt from datasheet]
SE~VOLiFT
", :;di.' ,;,;1:) j,,::,;

Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories S.A.,


Customer: Customer Reference 4500233630
Itapevi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

3,3.11.5. Position sensor 5, "NBB1 ,5-8GM40 ...

Manufacturer Pepperl & Fuchs

( Model NBB1,5-8GM40-E2-V1 I 601750


Ref. e-schematics 99B2,99B5,99B8,99B11

Specification
_~l_ connection:

...-;
)-. J
i"1= ~ 'f :~:tl
E2

design ~~J
1~1~ '~Lt
'BK
%;;;;""
:;'

LEO'
~
r-- ~~ ~~'--t L
1~ ~
M1:lx1
I .
- I

operating voltage 10- 30V DC

switching voltage 24VDC

( switching current Max.100mA


temperature
-25 .. ,+70C
range
indication
of switching state LED

switching element PNP

protection degree IP67


operating
1,5mm
distance
assured
0 ... 1,215mm
operating distance
installation embeddable connection type connector M12 x 1, 4-pin
[excerpt from datasheet]
SE=iVOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

1Date of Version 122. Dec 2015 1Version 1

3.3.11.6. Pressure sensor, "SC420"

Manufacturer tecsis
( Model SC420 1131556
Ref. e-schernatlcs 27B4,27B10

Specification

design

Isc.oo SCO'O ISCOID

I
ow., conlultl hun '. r- ....1.-.1' j'
't.VI r 'r "~I

( !Outfl'll"
Swllchlny Qulput.
_.
r ~,tw "lIurlllJ tt \Ill Itlt! d'S... .If
"'/JOt ('t'''Ojl rl(!(Jr1 324 HI
" , . ~ , .. ., .
"unjet S24;l(:
NIII'::~" ~IWJ "o'ilW1nl9 oU!....!s !)no 'S."i!:I1I.~ out: .. 1nr,'J r ...Q. ''I;1tCh1f1!J o .. !put Mil
_ .---~-.- .. _--'. _._- -- ._~~~'I.:':C'l~cl_O.UI._.!:'._ .'\:I_~I~.!IO.'.JLJ~_eu~...!..
SW't..:hlf'lD !lItlllllJII ....
O!'lInt"~" ( C'::'llo" , lIonf"l:~ c;lm..co(t\t;1 ~r mlnlh\Uy fJ~\lr11:NOJ
~~:ilY' t o..:~,on , 1 n ?,\:CPI'I"I
i'9{i'HI,,.iM 1(1 (l1lt''9t1
!r.,., [I ! ~
1'1II,w.1.I\lal\ j p ..;. n "..,.11 11111',

nominal pressure
'<:1)<".'.'
'11)161;:0'"
i
' ..'~" ofl~:i.n

I {J it,j/to 01 '.4i.ln

.~~t;r.;:"!."1;II.IiII"~
-; -.-.. _:.-t-!:P;.~:'. '''_._-
AnaiQQut outPui
lil.thJl1d i .11: V. ;; .,'hl

I
()t,I'u't :l
S~.ll"j 20 .. lIJl1'!-, o(t~~r';
\....OOdW~5!O,.CC. Cunl.tnt 1.!:,I;,)ul '"( <. ~~.:. ~1:1., ...

I
CUllt~l1tlJl,'.tllll ] \il',1114mr.;,
n 11l"J
r.1in Inttn~'1
~.J Ii. c~ -spiln for ccra:TUC Cof'
I
:) 2 ,.~ I~ !D(!!l 'j)t (1,111 I r" ~o"jll

.,'.:., v , 'I.11I11rllq
IIi \0' .. I.lll
arnper.lun, '.11\1".
":"llltnn ~tI ~j t.:
Vr"" :., &') <.:
An'I~(!nt 'n 7"\ I:
I r.," '...'11'1'"
Flactrl(::tt Cf)IIr.t:(;tiQf1 t IDUlI~ r.Olll~1 (., t.I ' .. _ I Jill'
Platedhl" clau' II? r,~'I.,t:r.o'~~ ,~ fG t:?11

LO;ldin9 c:::tp:aC.11y
Shot~ (r.:o:~h.:mll;.tll
~~~;~:l'~h"i1l1
5U9 w:;:ulllhlCj IQ 1t:~;'GCc:t!!! ~.::7
Vil'l:fol:iOI) , ... Ni' ,e~en.:'" ~t~",C,,~.;..~-,O; ~ ..
Wt:1 ht

[excerpt from datasheet]


5E~VOLiFT
Hardware Design Specification (HOS)

Type of Machine: I Container Blender J Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

3.3.11.7. Temperature sensor 1, "GN 650.6 ... " - monitoring hydraulic oil temperature

Manufacturer Ganter Otto

( Model oil temperature and level switch 1133206/ GN650.6 ...


Ref. e-schematics 5S3

Specification

.... connection:
-
l-c fIn N/~~
:)11'1(:11<1:,,1,,111
design

'.
~
-
LCd
technical data

voltage 150V AC / 48V DC

max. load 5A (10W)

max. current 5A

protection class IP65

connection cable, 2x1,5mm2

for monitoring and indication of hydraulic oil fluid level, but also for
triggering an electric pulse once a certain temperature is reached,
function
a sensor switches / opens a contact if temperature increases over
70C, this contact is provided as type 1xNC
[excerpt from datasheet]
SE=iVOLiFT
; I

Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No1 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer: Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 1Version: 1

3.3.11.8. Temperature sensor 2 - monitoring blend drive

The temperature monitoring of drives is realized with temperature switches or contacts,


type 1xNC (normally closed). If temperature does not increase an predefined value, contact
( remains closed. If temperature increases and overrun an suitable value, a fault is assigned and
the contact opens.
Then the feedback of sensor is assigned as a 24V DC signal to the digital input to the PLC. This
signal can be further processed, e.g. for triggering of a fault message.

SEW - blend drive (3M3)


Manufacturer
with Integrated temperature contact (thermostat)
Model SA 77 ORE 132S4 BE-11 rrH 18015842

Ref. e-schematics 3S3

13565_HDS_1_E.docx 35149
SE=iVOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratorlos SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

3.3.12. Actuators (valves, contactors, relay modules, etc.)

3.3.12.1. Hydraulic valve( s)

Manufacturer see hydraulic parts list

Model see hydraulic list

Ref. e-schematics see below in specification

Specification

The PLC control is connected with several digital outputs.


general function Hydraulic valves for controlling the machine's hydraulic functions
are connected to pic outputs which need a power supply of 24VDC.
function description Ref. e-schematics
H-VALVE: CLAMP 95Y2
H-VALVE: UNCLAMP 95Y4
H-VALVE: EXTEND CENTER CYL. 95Y5
H-VALVE: RETRACT CENTER CYL. 95Y7
H-VALVE: LIFT 95Y8
H-VALVE: LOWER 95Y10
H-VALVE: RELEASE FUNCTION CLAMP 96Y4
find further information in hydraulic parts list

3.3.12.2. Pneumatic valve(s)


Item is not applicable (n/a). There are no pneumatic valves used.

3.3.12.3. Electric valve(s) (127325, including 129499)


Item is not applicable (n/a). There are no electric valves used.

3.3.12.4. Further components


The other electric components such as contactors, relays, etc. can be found
in the document "electric parts list".

13565_HDS _1_E.docx 36 /
49
Type of Machine: I Container Blender I Servolift Project No. _j 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 I Version: 1

3.4. Interconnections

3.4.1. Plugs I Connectors

Sensors:
(
Most of the used sensors are connected via M12 plug cables, type V1-W-SM-PVC (611749).

Hlyedrau rIC VavI es:


Manufacturer Murrelektronik

7000-18021-2160300,
Model valve connector 1606903
Ref. e-schematics => hydraulic valves and electric valve (=> 127325, includes 129499)

Specification ,
features:
design form A (18 mm) => (28x28mm)
24 V AC/DC with LED and suppression

operating voltage 24 V AC 20 % I DC 25 %
operating current
per contact max.4A
( (40C)
protection IP65 and IP67 when plugged and screwed down (EN 60529)

temperature
range -25 ...+85 C, depending on cable quality
cable PVC, 3xO,75 mm"
[excerpt from datasheet]

Pneumatic Valves:
Item is not applicable (n/a). There are no pneumatic valves used.

Terminals:
Most of the connectors used in the system will be tension clamp connectors from manufacturer
'Weidmuller".
Alternatively connectors used in the system will be clamp connectors secured by screws.

Terminal boxes 1 enclosures:


Where located outside of the electrical cabinet all terminals will be located in discrete terminal
boxes from manufacturers "Rittal" or "Rose Elektrotechnik".
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evl - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

3.4.2. Cables
All main power and 24V DC supply cables are flexible types. Each cable end is labelled
with a unique cable number (Wxx). The cable number refers to the electrical component
see screenshot as example:
( e.g. sensor is labelled 23B2,
corresponding cable
is labelled W23B2

Sensor cables are "PVC" types.


In the "Cable Overview" in the electrical circuit diagram can be found further information.

3.4.3. Screening EMC


All cable connecting the main operator panel to the pic, the motor cable for the blend drives to the
frequency converter both requires to be screened to prevent interferences and to ensure reliable
( data transfer between the devices
SE=lVOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 1 Version: 1

3.4.4. Drawing schedules


For the electrical fabrication and installation the following overview contains the most important
components of the electric wiring diagram: The schematic structure provides a rough overview of
the content of the composition in the plan of the existing pages. To create the electrical wiring
diagram, the CAD software EPLAN is used. The creation of the electric parts list is also in EPLAN
( and is transferred into the PPS system SIVAS. The electrical wiring diagram and the electrical
parts list form a unit and are used after the completion of installation and testing as part of the
overall documentation.
In general, an electric circuit diagram consists of the following pages (depending on project):

- Front page
- T able of contents
- Change control I Modification Index

- Design (wiring) description


- Overview of machine in general and location of electric components
- Cable overview (single-line diagram)
- Cable overview (detailed)
- Electric cabinet (dimension and layout)
- Electric cabinet (mounting plate)
- Control panel (dimension and layout)
- Control panel (cut-out)

- Main circuit diagram(s)


- Circuit diagram(_s) with followingsub sections:
-
0 E-Stop circuit
0 Peripheral supplies
0 PLC-Arrangement (supply, interfaces)
0 HMI-Arrangement (su_Qply,interfacesl
0 Digital in-Ioutputs (connecting sensors, actors)
0 Analogue in-Ioutputs (connecting sensors, actors)
0 Connecting hydraulic./pneumatic valves

- Terminal diagram(s)

- Parts list of electrical components (separate)


SE=1VOLiFT
:', ;!'f:' ,:.l!,.'1

Hardware Design Specification (HDS)


Type of Machine: I Container Blender I Servo lift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122, Dec 2015 1Version: 1

3.5. Configuration

Configuration and setting points of electrical components (motor circuit, pressure switches,
temperature switches, etc.) are mentioned directly at the appropriate device in the electrical
drawing. If devices are programmable, a separate configuration file exists and will be included
( on the documentation CD.

example by red framed components:

-
W5S~_ ~
.'JJ.J
,

~,
5S3~_1
o.s
",!"

w~~~_

r.
X!/91 I.

ju

preset value of temperature switch,


here 5S3, set point> 70C
lSA2~' . ... -
~. - ~.. - .....
,'ln l(lI .!J
l
I
E126.0
I
,
( r----------
I
........ - - .......... - .. -
n::,.,PFRATURE
HYORAl,UC OIL
> ?\)'t =lOV,'
SE=lVOLiFT
: " . .: 's:' ~;

Hardware Design Specification (HDS)


Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


'Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122, Dec 2015 1Version: 1

4. Inputs & Outputs


This section describes all input and output field instruments connected to the Control System.
These are installed mainly in the main electric cabinet, if not, the location is mentioned.

4.1. Digital Inputs


There are used digital inputs integrated at the CPU313C.

Manufacturer Siemens
Model 57-300, CPU 313C 1613950
Ref. e-schematics 15A2

Specification

n
X11 X12
r- ---,
,,_ r--' ~ -

>.. ...
1,\.J.

"".'
!ol~'

I ~J
~",.'.~,. 2 a) :3

design I!I

(
!J'at.
r ~
'I

,.... .. , ,....
bloc diagram of CPU313C
- with integrated II0s

Tlie figures show the fo!iov.ing Integrated 1I0s


{1) Ai!3log liDs
{2) each wl;h ,g ClglUlI inj)Uts
{S) each wi,,", 8 aigl:al OUipl.;S

byte address 124,125,126

To expand the amount of further digital in-/outputs the modules type "Helmholz 700- 323"
and/or "Helmholz 700- 321" are used. For detailed information see following pages.

13565_HDS _1_E.docx 41 /
49
SE~VOLiFT
Hardware Design Specification (HDS)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

4.1.1. "Helmholz 700- 323" _ 16xDIO

Manufacturer Helmholz Systeme


Model "700- 323" 16xDIO I 613083
Ref. e-schematics 15A7

Specification
# digital inputs convert the external
binary signals from the process into the
c:: internal signal level of the
.Q programmable controller...
design t5
c:: # digital outputs convert the internal
~ signal level of the programmable
controllers into the external binary signal
level required for the process
700 12 118l00

N~~!':.:,I~t In.lt~:' . , Ir,


l~olll'I"IIII!"!1~ h,td:I'!.lfWhu.I .(\\~tOi't';ll..Ql!f'I!l'I'
h.':,!'~UI~o'~.,... Ilj

Input vultol9l'
IlCUI'l,\':lhlt' : l)f .!I \'
hll SI'I1.lIn~ \ ,:i, , ..:-\0
" l"l:;~jl~I"l" i ..1.1" ~ll)\'

tnllut C'unP.nt
fu~_"I" si!.ln~~ "V .. im,\
In ', 1 . 2 , .. .. ,::;1 1I~
('01111",'''(.111 01 t-wtrc ililhOllrtl _ . :\. ~ , ! > , .. - -_ ....
~~~~I,I . ' 1I: '~i~.I:~'I~:~lh,'.~I.I.tI.~~~~.\)'~:.~! 1)1.t". I.:'m.\
JI.,.H
C"IJlc'h:ncJlh
1111", :u11l111l
, UI\',hitldtd
'i1M;, IOU;lr'!I
~hh:hl~\d
1(.

hI)1~t10a ~UUlll1J;lci.?IJ1Wbtl:,
technical data ill
o~il~;u~~t ~~.._.
II,!>,'
Ilnm,\".llu('
l:]"",uvrll('
~Jll~~I.dl<~II~! !Uh:\'!~~)_I1_ _
: ~O \;
\'olt:'l&,' ilHt~~,~,:,t?~I'I~I:lt Itneu
11vtin~III~i.ltr<1",'
1111\ :6ll(Jllt
C,,~lr IcnUlh
1:11\ U)uOm
UI1>;ll1thJ('d
~lIlt'ld,'d
: i)C)-I\'
SUltply vnl!;J9p. V,.. V:
tlW:'13,6\'
1\9n1,\.1111t"
: .'O,.. 30r
11~'VI('\';,
Ilt'III1I;'/ll'l~ ,.u\:~.\wlill I ippl\")
m.M', i .~oy,
,',llm",ltt' llJltI~

Cutrl:nt VJMUnllltiOIl

-
hOI1l .) 1 \'J
_''',Id,

-- -
,,'~I\'U1 ~1 tW hhont
._

Inh'lIl.1l (L:.~('I,'II,UIt' Ilml 11111:\, \ ~IUIllA

_ .111':.: J.J~~~~,
t)'I" :v.U\'
-11).1\'.1:-'

byte address 0, 1 H't' ,,,0(;"(


: ,~5"C ". is'\,:
datasheet]

13565_HDS_1_E.docx 42 /
49
SE=1VOLiFT
;,,~..,:.: ~.,~:. j~)( .~":

Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA, Customer Reference 4500233630


Customer:
Itapevi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 I Version: 1

4.1.2. "Helmholz 700- 321" _ 16xDI


There are used digital inputs integrated at the CPU313C. An additional module
type "Helmholz 700- 321" is used. This is also installed in main electric cabinet.

( Manufacturer Helmholz Systeme


Model "700- 321" 16xDI 1613079
Ref. e-schematics 15A8

Specification

c # digital inputs convert the external binary


design
:fi signals from the process into the internal
c signal level of the programmable
~ controller...

, 700321IBH02
.-.- ..- .....- ..- 1-.- .-...- _..-.,- -_ .. -.- ..-.-.! .-
I
..- ...--- - .-.....- ..- ..- --
- .'_ ... - - - - . . . - .. .... - ".- ..-._. -- .... --- .. _. '.'1!'"16 ----' .. -.' .... '- "-".- - - .....--I
o li l l PU I S :
ISl,j.ltiUIlIIf()tU h;ld;PI'H.I'.' bUil ! i
\".~ 8 IOphJfl1Ilph:c,
1t' u ps
- - .
j
i
I ~ P ; ~ '~ ~"a-9_~._-'. --" ..- .. _....
I I I

lh
(If

-'-'1"-
( IlI.lIl'- \":,h:..: U(, .!4 v I
i
.. " I ~..1.:,:''~'!I~y.. _.'._ .. " ". _ '"

.~lj~I~:.~.r.~~~".~..~. ,,~~ ." ."_ .~ ...


ItI~ "(1" :.i;::l1dl .1 .. , I:; Y I

.~~!.;t::I'~!~;::~I._ .... ,. _ .. '.' _ ..._.... _.._ .... _ I~:!" 7 111.\ i


technical data 11111\' ~L:'-i:s;,;,.~~~_. ~.J,
CUlllw,,'lion c1i '?\\'irv illtfl.JhU
1_1:~n_J.I: ~l~I~~:'~:.'~I.~I_C_t."',"rh"!t..I~' "'~;.!II.II ~
"t"
_ _ IllttS_: 15111:\ i
I Collie len!!th
I uu.)hh'l,)t-li Uh)X, (Itlum

I ~;~~~~~'~,;';~-;'-ii.o_'n.-'--------......!ll:'~' 111110 III

I ' 1111.,,,,11\bad;plillWUIII)
.. :
I~I'.2 n m A
,~:~!~~~t~~!~:l_~~_~~.~-,~,_..-_. _ .. J:l~~. 1 4 1 )""\
I
v ~

.I.,'_I:~~~\~!.~.t :~;i.l~~~M! ~.I!~:~:I ~,~~ ' , I !).


# " . .... .. _.". '. .. _ , I_yp:

II ( , (If) \

~:. ( '. -, l

byte address 4,5


[excerpt

13565_HDS_1_E.docx 43 /
49
SE=-1VOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA, Customer Reference 4500233630


Customer:
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

4.2. Digital Outputs


There are used digital outputs integrated at the CPU313C.

Manufacturer Siemens
( Model S7-300, CPU 313C 1613950
Ref. e-schematics. 15A2

Specification
X12
-
X11
r--

'-
. --' ._ r--'

,,
~t\.l.'

",

.
."
~ - ;),

"
"1

~.~
HJ
:.J""

I
:l

~
design II!!
1

bloc diagram of CPU313C


1..-
-= with integrated II0s

The figures show the lolfoWing I~tegrated 1I0s


(1) Ai/3IQ9IiOs
(2) eocn wl:" .9 Oltll:JIIIlD1.lts
(S) each wljii S d!gl:.:I1 oulp,.::>

byte address 124,125

If further digital outputs are necessary the module type "Helmholz 700- 323" is used.
SE=-1VOLiFT
Hardware Design
For detailed Specification
information (HDS)
see following chapter. All modules are installed in main electric cabinet.

4.2.1. "Helmholz 700- 323" -16xDIO


See information at previous item, where module is described.
SE~VOLiFT
Hardware Design Specification (HDS)
Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 1Version: 1

4.3. Analogue In-IOutputs


The blender is a variable speed machine with a range of speeds being selectable by the
operator panel. The control of speed is achieved by the frequency converter. The blend speed
can be adjusted by inputting new values at the HMI terminal. The analogue card will be used
to provide the variable voltages for the frequency converter.
(

4.3.1. Analogue Inputs / Analogue Outputs

There are used analogue outputs integrated at the CPU313C.

Manufacturer Siemens
Model S7-300, CPU 313C 1613950
Ref. e-schematics 15A2

Specification
X11 X14!
---,
~~ -
."...,-

._

I ~~ 'N:,

i ,J
"'!'\~

~
~. " .
design
f t "

r ~
!I!
.~ ,.
\ ) '

-
bloc diagram of CPU313C
..._, r-- with Integrated II0s
1
-- ..-
The flol)ro~s show the follOWIn~Integrated II0s
I (1) Analog liOs
(2) each wi\l1 8 cigl!al inputs
(3) each ~vi:n8 d!gi:31 outpias

address AI PEW 752 - 754 - 756 - 758 - 760


address AO PAW 752 -754
SE=iVOLiFT
Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma t.aboratonos SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 I Version: 1

4.4. I/O Listing

The detailed assignment (function, description, labelling) of the used sensors and actuators can
be taken from the separate document, called "13565_HDS-IO". This will be used as basis for the
programming and for testing purposes, e.g. the functionality or signal exchange. Each revision of

assignment of sensors and/or actuators, which will be added are removed, or renamed by tag
( number is only done in this "HDS-IO" document itself.

5. Environment
This section shows the minimum and maximum environmental conditions
that the PLC equipment will be suitable for.

1. Temperature o -40 C

2. Humidity 10 to 65% RH

3. External interference see technical data of the appropriate device

4. Radio frequency,
see technical data of the appropriate device
electro-magnetic and UV-interference
SE=iVOLiFT .!. , .
< .

Hardware Design Specification (HDS)

Type of Machine: I Container Blender I Servolift Project No. I 13565

Eurofarma Laborat6rios SA,


Customer: Ita evi - Sao Paulo, Brazil Customer Reference 4500233630

1Date of Version: 122. Dec 2015 1Version: 1

6. Electrical Supplies
The section describes minimum of supply requirements for the configured hardware system.

6.1. Filtering
To avoid electromagnetically interference a filter is integrated in the VFD according EN55011-1A.

6.2. Loading
The general power can be switched on/off with the main switch on the electric cabinet's door.
A power supply unit breaks down the voltage onto 24V DC to supply the PLC with additional
periphery also as for sensors and other devices too. The main power supply should match
following requirements:

voltage 380 VAC


frequency 60 Hz

input lead 5x6 rnrn"


power 12 kW

fuse 25 A

control voltage 24 VDC


(

6.3. Earthing protection


All devices consisting of metal housings are connected to earth potential, directly, or by wiring.

6.4. Uninterruptible power supply (UPS)


Not applicable, not part of the contract.
Hardware Design Specification (HDS)

Type of Machine : I Container Blender I Servolift Project No. I 13565

Eurofarma Laboratories SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

1Date of Version: 122. Dec 2015 I Version: 1

7. Glossary

1.1. Definitions
The following definitions apply to corresponding terms which may be unfamiliar to the readership:

Term Definition
PLC Programmable Logic Controller
E-Stop Emergency stop
LED Light Emitting Diode
EMC Electro-motive compatibility
FAT Factory Acceptance Tests
FS Functional Specification(suRplier prepared documents)
HDS Hardware Design Specification (supplier prepared documents)
HMI Human- machine interface
Hz Frequency (Hertz) Cycles/second
I/O Input/output
AI Analogue input
AO Analogue output
DI Digital input
DO Digital output
protection
IP54
against splashing water from all directions, limited ingress of dust permitted
IP65 protection against splashing water from all directions, total protection from dust
KW Kilowatt (Electrical power)
MMC Micro Memory Card
MPI Multi- point interface
n.a. not applicable
N/C Normally closed
N/C Normally opened
PLC Programmable Logic Controller
printer command language, developed by HP as a printer protocol which has
PCL6 become an industry standard
RAM Random access memory
RH Relative Humidity
SDS Software design specification
CPU Central Processing Unit
URS User re_guirement specification
USB Universal serial bus
V voltage (Volts)
V voltage (volts)
VAC volts alternating current
VDC volts direct currents
SE=tVOLiFT
:. :l.ti'!J/l(: :.;).(,;+-i'_ .'

Hardware Design Specification (HDS)

Type of Machine: I Container Blender J Servo lift Project No. I 13565

Eurofarma Laboratorlos SA,


Customer: Customer Reference 4500233630
Ita evi - Sao Paulo, Brazil

I Date of Version: 122. Dec 2015 I Version: 1

8. Attachments
Main components of the electrical parts

1. Datasheet DB_CPU313C_E.pdf
separate on CD

2. Operatinglnstructions_31 xC_and_31 x_E.pdf


separate on CD

3. Datasheet DB_ TP1200_12_E.pdf


separate on CD

4. Operatinglnstructions_ TP1200 (WinCC advanced)_E.pdf


separate on CD

5. electrical schematics
13565_EP, current version

6. electrical parts list


13565_ST, current version

7. pic input/output assignment list


13565_HDS-IO, current version
(

~ END of document -

13565_HDS_1_E.docx 49 /
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tijetime solutions

Installation Qualification (IQ)

I Type of Machine I Container Blender I Project No. 13565

I Date of Version lOB. Jan. 2016 I Version 1

Installation Qualification
for
Container - Blender
13565
(
Eurofarma Laboratcrlos S.A.

Itapevi - Sao Paulo


Brazil

Servolift Name I Signature Position Date

M . r A.7~L Technical
Written by: Sl g : OB.Jan.2016
editorial dept.
k.
. I

Mr. R. Kre~r ./.


( Reviewed by: Sig: !. .~- Project engineer OB.Jan.2016
l /
Mr. D. ~alser
Approved by: S19: 1 A I ,", " Leader design dept. OB.Jan.2016
! I '/,
' ,/ r 'iI"
" , .'

Customer Name I Signature Position Date

Reviewed by:
Sig:

Reviewed by:
Sig:

Approved by:
Sig:
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Installation Qualification (IQ)


:~. ------_._._------------------------_--_. ._--_._._-----,-.--~.- _. _. _. .. _.. ... - .-- .. -.- ----_. '1'112
File: 13565_IQ_1_E.docx
SE=lVOLiFT
lifetime solutions

Installation Qualification (IQ)

I Type of Machine I Container I Project No. 13565

I Date of Version
Blender 108. Jan. 2016 I Version 1

table of Contents
List of persons, involved in qualification: 3

2. Document History - Change Control 4

3. Identification 5
3.1. General Data 5
3.2. Reference Documents 5

4. Scope of Delivery 6

5. Installation 7
5.1. Assembly 7

6. Utilities 8
6.1. Mains 8

8. List of Deviations I Repair Work 11

9. Final Statement 12

File: 13565_IQ_1_E.docx
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Installation Qualification (IQ)

I Type of Machine I Container Blender I Project No. 13565

I Date of Version 108. Jan. 2016 I Version

1. List of persons,involvedin qualification:

Responsible
Person:

Name Company Date Signature acronym

Name Company Date Signature acronym

Name Company Date Signature acronym

Name Company Date Signature acronym

Name Company Date Signature acronym

File: 13565_IQ_1_E.docx
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Installation Qualification (IQ)

I Type of I Container Blender I Project 13565

I Date of
Machine 108. Jan. 2016 I Version
No. 1

Version

2. Document History - Change Control

the following list registers the execution of changes for this document.

Verso Date Editor Reason for Change


(
1 08. Jan. 2016 KA Initial version

File: 13565_IQ_1_E.docx
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Installation Qualification (IQ)

I Type of I Container Blender I Project 13565


--_.- -4/'12
Machine No.

File: 13565_IQ_1_E.docx
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Installation Qualification (IQ)

I Type of Machine I Container I Project No. 13565

I Date of Version
Blender 108. Jan. 2016 1 Version 1

3. Identification

3.1. General Data

Manufacturer Servolift GmbH

Type Container Blender

( Machine Number 13565

P.O. Number 4500233630

Number of Order Confirmation 1131069

General Drawing 13565-00-001

Technical Description FS/FDS dated 16. Sep. 2016

~.2. Reference Documents

Document Version (current indices)

Function Specification I Function Design


( Specification (FS/FDS) 13565_tb1

General Arrangement Drawing 13565-00-001

Factory Acceptance Test 13565_FAT_1_E

Hydraulic scheme 13565-61-001

Electric scheme 13565

Remarks

Confirmed I Signature Confirmed I Signature


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Installation Qualification (IQ)

I Type of I Container Blender I Project No. 13565

IMachine
Date of Version 108.Jan.2016 I Version 1

4. Scope of Delivery

Pos.: Description Yes No

4.1. Container Blender 1000 kg, freestanding

4.2. Operating Terminal


(
4.3. Recipe Management

4.4. Printer installed into stainless steel box

4.5. Potential free contact

4.6. Qualification documentation for blender (IQ, OQ, FAT, FS/FDS, SDS, HDS)

4.7. SERVOLIFT Standard Documentation

4.8. Translation of manual into Portuguese language

Other non-listed items as service work, packaging and transport are not
relevant for qualification, and thus not included in this table.

INFORMATION

Remarks

Confirmed I Signature Confirmed I Signature


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Installation Qualification (IQ)

I Type of I Container Blender I Project No. 13565

I Date of Version
Machine 108. Jan. 2016 I Version 1

5. Installation

~.1.Assembly

Pos.: Description Acceptance Criteria Yes No

Floor anchored and complete column


Stationary container blender 100O
5.1.1. with hydro lift system and electric blend
kg lift capacity
gear

Floor installation by delivered Unit anchored to floor by compound


5.1.2. compound anchors anchors M16x125

Separate hydraulic I electric cabinet Separated compartments for electric and


5.1.3. installed near blender hydraulic components each

Hoses and cables installed according to


5.1.4. Hydraulicl electric connection enclosed schemes

5.1.5. Electric supply Into control cabinet

5.1.6. Control cable from operator panel Into control cabinet

Checked according to scheme with single


5.1.7. Electric installation
core labelling.

Electric and hydraulic supply lines


installed acc. to schemes, arm bolted to
5.1.8. Supporting arm
( blend gear by 36 pes. M12 x 45, refer to
drwg "assembly of frontcase to lift slide"

Operator terminal outside blend Siemens terminal 12"- installed into built-
5.1.9. room in panel

Installed into stainless steel box below


5.1.10. Laser printer
the operator panel

Automati c greaser activat d acc. to Eye of eye screw is broken off


5.1.11. enclosed instruction

Sensors for positions and installed and adjusted into the column
5.1.12. temperat res

Remarks

Confirmed I Signature Confirmed I Signature

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Installation Qualification (IQ)

I Type of Machine I Container Blender I Project No. 13565

I Date of Version 108. Jan. 2016 I Version 1

5.1.13. Hydraulic powered pivoting clamps Installed at supporting arm ace. schemes

Hydraulic tank filled (approx.s.s It)


Tank filled, level at upper mark, seen with
5.1.14. food grade quality
arm at minimum height
"FOODMAX AW 46"

Checked and confirmed on drwg.


5.1.15. Main dimensions and heights
13565-00-001
(

,
6. Utilities
6.1. Mains

Pas.: Descri ption Acceptance Criteria Yes No

Power supply
6.1.1. Supply to the electric cabinet
380 V, 60 Hz, 3Ph, PE, 13 kW

Control cable from control cabinet to Installed to terminals according to electric


6.1.2. operator terminal scheme
(
Site supplied into control cabinet ace. to
6.1.3. Ground cable scheme

Remarks

Confirmed / Signature Confirmed / Signature

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Installation Qualification (IQ)

I Type of Machine I Container I Project No. 13565

I Date of Version
Blender lOB. Jan. 2016 I Version

'1. Documentation Check

Pos.: Description Yes No


7.1. Owner's manual in English language (1-Fold as paper; 1-Fold on CD)

7.2. Declaration of Compliance acc. DIN EN 10204- 2.1 - 13565

7.3. Calibration Protocols of Blend Speed and Time


(
7.4. Drawing - Blender 13565-00-001

7.5. Drawing - Lift Cylinder 111776

7.6. Drawing - Assembly Front Case with Bearing 03-39-203

7.7. Drawing - Rotary Unit 7-Fold 03-64-401

7.B. Hydraulic Scheme 13565-61-001

7.9. Hydraulic Parts List 13565

7.10. Hydraulic Hose List 13565

7.11. Spare Parts List 13565

7.12. Electric Scheme 13565

7.13. Electric Parts List 13565


(
7.14. Installation Instruction and Safety Data Sheet of Compound Anchors HILTI

7.15. Safety Data Bulletin of Hydraulic Oil FOOD MAX

7.16. Safety Data Bulletin of Grease SO RAJA

7.17. Safety Data Bulletin of Automatic Lubricator PERMA

7.1B. Safety Data Bulletin of blend drive gearbox oil SHELL OMALA 6BO

7.19. Qualification Documentation consisting of FAT, OQ, IQ, FS, FDS, SDS, HDS

Remarks

Confirmed / Signature Confirmed / Signature

File: 13565_1Q_1_E.docx
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Installation Qualification (IQ)

I Type of Machine I Container Blender I Project No. 13565

I Date of Version loa. Jan. 2016 I Version 1

The documents listed below are available only on CD-Rom after FAT

7.20. PLC-Program of Terminal and Blender Control

7.21. Operating Instructions of Blend Motor and Gear SEW

7.22. Operating Instructions of Frequency Converter DANFOSS


(
7.23. Operating Instructions of HMI Terminal

7.24. Parameter Settings of Frequency Converter

7.25. Translation of manual into Portuguese language

Remarks

Confirmed / Signature Confirmed / Signature

File: 13565_IQ_1_E.docx 1oT12


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Installation Qualification CIQ)

I Type of Machine I Container Blender I Project No. 13565

I Date of Version 108. Jan. 2016 I Version 1

8. List of Deviations I Repair Work

All defects, which are detected during FAT tests, are listed below together with the necessary actions
to eliminate the defects.

No. Test No. Defect I Measure to eliminate Responsibility Date

(
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Installation Qualification (IQ)

I Type of Machine I Container Blender I Project No. 13565

I Date of Version 108. Jan. 2016 I Version 1

9. Final Statement

D The equipment meets the requirements made in the purchase contract.


No defects found out.
The 10 is successfully finished.

D The equipment meets the requirements made in the purchase contract.


Please consider the comments: Defects were found and have to be eliminated.
The 10 is successfully finished, when the defects are eliminated.

Name / Signature Position Date

Reviewed by:
Sig:
(
Reviewed by:
Sig:

Approved by:
Sig:

File: 13565_IQ_1_E.docx

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