DQ - Wfi

Pharmalab
700 Ltr/hr. WFI GENERATION

PLANT
Revision: 00
DRD : Page 1 of 50
Design Review
Pharmalab
DESIGN
REVIEW FOR
700 Ltr/hr. WFI GENERATION PLANT

With Mitsubishi PLC (With Real Time
Tracking) E-1061 HMI
PLC Validation at Pharmalab After FAT
QR-731-05,
Rev. 00
Page 1 of 50
Pharmal
ab

PLANT
Job No.: XXXXRevision: 00

DRD : Page 2 of 50
Design Review
CONTENT
1.0
DESIGN REVIEW REPORT APPROVAL
2.0
SYSTEM INFORMATION AND PROTOCOL DETAILS
3.0
ACCEPTANCE CRITERIA AND RESPONSIBILITIES
4.0
BASIS OF DESIGN & ASSUMPTION / VARIATION
5.0
GENERAL DESIGN QUALIFICATIONS
6.0
TECHNICAL SPECIFICATION (With Respect to Purchase Order)
12
7.0
UTILITIES REQUIREMENTS
13
8.0
SAFETY FEATURES
14
9.0
SYSTEM DESCRIPTION AND OPERATION
15
10.0
LIMITING CONDITIONS FOR PERFORMANCE OF EQUIPMENT
35
11.0
INSTALLATION AND START UP
36
12.0
IDENTIFICATION OF COMPONENTS FOR CERTIFICATION &

CALIBRATION
38
13.0
LIST OF COMPONENTS
39
14.0
LIST OF DRAWINGS
48
15.0
LIST OF DOCUMENTS
48
16.0
CERTIFICATION
48
17.0
FINAL REPORT
49
18.0
APPENDIX
50
Pharmal
ab

PLANT
Revision: 00
DRD : Page 3 of 50
Design Review
1.0 DESIGN REVIEW REPORT APPROVAL

Remarks: Approved / Not Approved
FOR :
H.O.D.
Name
Designation
Signature
Date
Project
Engineering
Production
QA / QC
FOR M/s. Pharmalab

Design
Revision Control (if any)

Date :
Revision No : 00
Description of Revision
Pg. No.
Point
Old Description
New Description
Checked by ..
Approved by
Date
Date.
Rev
No

PLANT
Pharmal
ab
Revision: 00
DRD : Page 4 of 50
Design Review
2.0 SYSTEM INFORMATION AND PROTOCOL DETAILS

2.1 System Information
Pharmalab
Santej Vadsar Road, Village Santej, Taluka Kalol, Dist. Gandhinagar.
Supplier
Customer
Site
Proposed
Installation
Location
2.2 Protocol Details
Protocol Generated By
Asst. Manager Design
Pharmalab
2.3 Protocol Approval from Customer

H.O.D.
Project
Engineering
Production
QA / QC
Name
Designation
Date

PLANT
Pharmal
ab
Revision: 00
Design Review
DRD : Page 5 of 50
2.4 Objectives of this Protocol
To provide the specifications, operation and installation requirements of the

WFI PLANT for which it is designed.
To specify the Performance basis for acceptance of the WFI PLANT.
2.5 Scope of this Protocol
This review protocol will define the responsibilities, acceptance criteria, basis
of design, technical specifications, list of major bought out parts, utility
requirements, safety features and documentation requirements.
The protocol also defines the basis of Factory Acceptance Test, Site
Acceptance Test, Installation Qualification (IQ), and Operational Qualification
(OQ).
The design review is an essential part of the qualification mechanism and will
serve as a basic document for the Validation activity.
Pharmal
ab

PLANT
Revision: 00
DRD : Page 6 of 50
Design Review
3.0 ACCEPTANCE CRITERIA AND RESPONSIBILITIES

3.1 Acceptance Criteria
a. The WFI Generation Plant design confirms to ordered specifications.
b. As per USP, WFI should have
Conductivity
: Less than 1.3 s/cm at 25C
TOC
: Less than 500 ppb
Endotoxin
: Less than 0.250 EU / ml
WFI Temp.
: 90 C 98 C
Bacteria (TVC)
: Less than 10 cfu/100 ml
Heavy Metal
: NMT 0.1 PPM
Nitrates
: NMT 0.2 PPM
pH
: 5 7 at 25C
3.2 Responsibilities
Customers Responsibility
1.
To provide the technical specifications for design along with the Purchase
Order.
2.
The
WFI
Plants
performance
requirements
are
demonstrated
after
Installation as per the SAT.

3.
Validation of quality of WFI is in customers scope.
4.
Provide the input utility as specified in the point 4.2 and 7.0.
5.
The heads of Project, Engineering, Production and QA/QC (Consultants - if

applicable) will evaluate the results and approve the Protocol & its results.
6.
To check the suitability of the placement of the WFI Plant at the location.
7.
To give the approval of Drawings and Design Review within the 10 days.
8.
Customer defined protocol for FAT should be approved by Pharmalab along

with DR approval.
9.
Customer will extend the header air vent line from header to venting Point on
Pharmal
ab

PLANT
Revision: 00
Design Review
DRD : Page 7 of 50
site.
10. To provide Moisture separator with steam trap and PRV at inlet of Plant
steam.
11. Purified Feed water supply at max 2 Kg/Cm2 pressure confirming to following.
Conductivity less than 5 s/cm, TOC less than 500 ppb, Bacteria (TVC) less
than 100 cfu/ml, Temperature ambient, Endotoxin less than 250 EU/ml, All
other as per USP purified water.
12. Cooling water supply gravity/max 2 Kg/Cm2 pressure & of less than 90 PPM
TDS (Cooling tower water is not advisable to use as a cooling water for Water
Still).
Pharmalabs Responsibility
1.
To invite customer for the FAT at Pharmalab, Santej.
2.
Scope of FAT is as follows
a)
Installation Qualification
b)
c)
Dimension Verification against GA drawing.
Verifications of Material of construction certificates.
Verification of WFI PLANT with P & I Diagram.
Verification of Pressure test certificate.
Factory setting for various Instruments
Verification of calibration certificate of all instruments.
Operation Qualification
PLC input/output check and testing of all inter locks-safety
Trial Run
Endotoxin Test
WFI Flow Rate 700 LPH at 3 kg/cm2 Pressure of Boiler Steam and
Conductivity Test for WFI.

PLANT
Design Review
Pharmal
ab
DRD : Page 8 of 50
4.0 BASIS OF DESIGN & ASSUMPTION / VARIATION

4.1 Basis of Design
Supplier on the basis of their expertise and technology will work out the complete
specifications of all components required for the manufacturing of this WFI PLANT.
4.2 Assumptions (Customer is responsible to maintain the Quality of the Utility)
Boiler steam supply dry, saturated and free from impurities at 3 Kg/Cm2 pressure
and minimum 143 C temperatures.
Electrical Power Supply 415 V 5%, 3 Phase, 50 Hz, Neutral & separate
earthing for power and control supply.
Dry and oil free compressed Air supply for Pneumatics will be at 6 Kg/Cm2
pressure.
Cooling water outlet temperature will be 90 C to 98 C
4.3 Variations
If there are any variations sought by Client after approval of general arrangement
drawings and P & I diagram, Room Layout and Design Review of the WFI PLANT
from the original design then the same will be incorporated by supplier of the WFI
PLANT design after receipt of approval in writing from the Client provided that there is
no any price implication & delivery constraint and if any price implication for
changes asked by customer, the customer has to amend the Purchase Order
the
&
Delivery Date. This will form the basis for finalizing As Built general arrangement
drawings and P & I diagram.
If after approval of DR, supplier will change any specifications as improvement,
supplier has to take approval of these deviations from customer for the same.
M/s ABC PHARMA PVT.

LTD.

PLANT
Pharmal
ab
DRD : Page 9 of 50
Design Review
5.0 GENERAL DESIGN QUALIFICATIONS

Sr.No.
Heading
Specifications
5.1
Application
To Produce water for injection
5.2
Capacity
Working: 700 LPH at 3 Kg / Cm of Plant steam
5.3
Outer
Operating Pressure 6 Kg / Cm
Column Shell
Operating Temperature 165 C

Design Pressure 6.5 Kg / Cm
Design Temperature 185 C
Hydrostatic Test Pressure 9 Kg / Cm
MOC - SS 316L Sheet , 2.6 mm thick
Inside surface finish 0.6 Ra, Electro Polished
Outer surface finish Mirror (Mechanical Polished)
Qty 5 Nos.
5.4
Condenser
Shell Side
(Inner
column)

Design pressure 6.5 Kg / Cm
MOC - SS 316L Sheet, 2.6 mm thick
Inside surface finish Electro Polished
Outer surface finish (Contact Parts) 0.6 Ra Electro Polished
Qty for Double tube sheet 1 No ( First condenser )
Qty for Single tube sheet 4 Nos. ( Other condenser )
Tube Side
MOC - SS 316L seamless Tube
Internal surface finish Mill polished
st
Outer surface finish - 0.6 Ra, Electro Polished (except 1
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT

DRD : Page 10 of 50
Design Review
condenser)
5.5
Feed
and
Water
Shell Side
Cooling
Water Cooler

MOC - SS 316L Sheet , 2.6 mm thick
Inside surface finish 0.6 Ra, Electro Polished
Outer surface finish Mirror (Mechanical Polished)
Qty - 1 Set
Tube Side
MOC - SS 316L seamless tube
Outside surface finish Electro Polished
Internal surface finish Mill Polished
5.6
Stand
MOC SS 304 Square pipe , 50 x 50 x 2 mm thick &

Rectangular Pipe, 100 x 50 x 2 mm Thk.
Mounting Leg mounting (Adjustable 50 mm )
Surface finish Mirror (Mechanical Polished)
5.7
Insulation
Cladding Riveted
Cladding MOC SS 304 sheet, 1 mm thick
Outer surface finish Mirror polished (Mechanical Polished)
Insulation thickness 50 mm (Uncompressed)
Insulation material Resin Bonded Glass wool with K Factor
0.39 W / mk
5.8
Separator
MOC SS 316L sheet , 1 mm thick

Surface finish, Electro Polished
Qty 5 Nos.
5.9
Gasket
MOC PTFE / Silicon
QR-731-05,
Rev. 00
Page 10 of 50
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT

DRD : Page 11 of 50
Design Review
Type - Food Grade
Temperature 200 C
5.10
Construction
As per GMP
Features
Contact surfaces Crevice-free, Rounded corners

Nozzles Triclover, Fittings Sanitary
Dead leg 3 D wherever technically possible.
Slope 1 in 100
5.11
Overall size
Overall Depth - 1400 mm
(Approx)
Overall Height - 3050 mm

Overall Width - 3000 mm
WFI outlet height 2225 mm
5.12
Pipe line
Pure steam line

MOC SS 316L, 50 mm OD x 1.6 mm thick, ERW
Internal finish 0.8 Ra, Electro Polished
Outer finish Mirror, Mechanical polished
2) Main WFI outlet line
MOC SS 316L, 38 mm OD x 1.6 mm thick, ERW
3) Cooler air vent line
MOC SS 316L, OD x 1.6 mm thick, ERW
Feed water, WFI inter connecting and cooling water line
MOC SS 316L, OD x 1.6 mm thick, ERW
5) Steam line
MOC SS 304, 1.5 NB x SCH 10,
Internal finish Mill polished
5.13
Welding
Pipe Line by Orbital Welding wherever technically possible.
Fabricated Parts by TIG welding
QR-731-05,
Rev. 00
Page 11 of 50
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT

DRD : Page 12 of 50
Design Review
6.0 TECHNICAL SPECIFICATION (With Respect to Purchase Order)

Sr.No.
Heading
Design Provision
6.1
Model No
700 WS
6.2
Output
700 LPH at 3 Kg / Cm of Plant steam
6.3
Operation
Automatic with real time printing
6.4
PLC
Mitsubishi PLC with HMI: E - 1061
6.5
Purified Water
Pressure Sensing
6.6
Indication on control panel
6.7
Packing Box Size

(Approximately)
LxWxH
6.8
Type of Box Packing
Local Packing
6.9
Printer
Epson Lx-300, 80 Column Dot Matrix Printer
6.10
PLC Validation
At Pharmalab after FAT
6.11
Other Requirements
PLC Programme Hard Copy to be provided
HMI
Emergency Push Button
Main Machine
130 L x 128 W x 60 H
M/s ABC PHARMA PVT.

LTD.

PLANT
Pharmal
ab
DRD : Page 13 of 50
Design Review
7.0 UTILITIES REQUIREMENTS

Sr.No
Utility
Supply
2
7.1
Boiler Steam
At Min 3 kg/cm
pressure and 143
C temperature
2
7.2
Feed Water
At 2 Kg/cm Pressure &

Ambient Temperature
Requirement
Max.: 250 Kg/
Hr Min : 175
Kg/Hr
Nozzle
1.5" ASA # 150
Flange
Max. : 1150
LPH Min : 805
1 Triclover
LPH
7.3
Cooling
water
At 2 kg/cm Pressure
& Ambient
Temperature
At 415 V, 50 Hz, 3
7.4
Electricity
Phase + Neutral
Max. : 1225
LPH Min : 860
1 Triclover
LPH
Max: 3 KW
N.A.
+ Earthing
7.5
Compressed
Air
At 6 Kg/cm Pressure
5 CFM
BSP-Female
Thread
1 Triclover to
7.6
WFI outlet
----
----
suit 1.5 OD
Pipe
7.7
7.8
Header Drain
Header
Air Vent
----
----
----
----
1.5 BSP
Female thread
1 BSP
Female thread
To retain the memory, power should be given to PLC & HMI at least once in 3 months
after dispatch date.
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT

DRD : Page 14 of 50
Design Review
8.0 SAFETY FEATURES

Sr.No.
8.1
Safety
Condenser Assly
Safety Provision
Safety valve provided on the plant steam inlet at
column Assly
Set Point: 6.1 kg/cm
8.2
Feed Pump
1. Thermal Overload relay

2. Feed Water pressure sensor at the inlet of
the feed pump
3. Pneumatic Valve at pump outlet
8.3
Cooling Pump
1. Thermal overload relay

2. Cooling Water pressure sensor at the inlet
of the feed pump
3. Pneumatic Valve at pump outlet
8.4
Last Column Waste Water

Level Control
8.5
Operational safety
Float type level Controller

1. Emergency OFF
2. Operating Air Pressure Low
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT
Design Review

DRD : Page 15 of 50
9.0 SYSTEM DESCRIPTION AND OPERATION

9.1 PRINCIPLE OF OPERATION
Pharmalab WFI Generation Plant produces Pyrogene free, sterile, Water For
Injection
(WFI). It operates on the Distillation as a Unit Process. Sterile water generation engross
with Liquid Vapor - Liquid phase change to produce very high purity water. It removes
the impurities at sterile temperature without using any filtration medium.
Equipment is based on Falling Film Evaporator principle. It is most reliable method to
produce WFI. It employs high temperature (Sterile state temperature), which assures
constant sterile water. As unit does not have moving parts, it demands very little
maintenance.
9.2 OPERATION: BASIC
The Unit designed to remove microbial contamination by Three Stage Separation.
Number of effects is connected in series. Each effect has a innermost evaporator (Shell &
Tube heat exchanger), an intermediate separator and outer columns. Source of energy for
the first effect is Boiler Steam and the remaining effects use the intrinsic heat to
supplement consumption needs of the heating energy.
Feed water is preheated by waste heat recovery method and enters the first Effect from
tube side. Specially designed Distribution plate ensures the water falls down the tube as a
Thin Film. The falling film is heated with plant steam and causing it to a instant Flash
evaporation. This Flash evaporation helps the steam to leave behind the heavier particles
or droplets. (First Stage of separation). This transformation from
water to steam significantly increases the velocity as it approaches the bottom of the
column with high pressure.
This vapour as it moves outside the tubes, is forced to change its direction to a 180 turn.
This directional changes induces the separation of large water droplets (secondary
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT
Design Review

DRD : Page 16 of 50
Separation), which fall into the bottom of the column, where they are collected with excess
feed water that has not evaporated.
As the steam moves upwards, the spirals provided on the shell of the evaporator force the
steam to move in a circular path. The resulting centrifugal action forces the remaining
microscopic droplets and impurities including the Endotoxins to the outer surface, which
then gets blown down through the windows provided on the separator. (Third Stage
Separation) The resulting steam is Pure Pyrogene Free Sterile Steam.
Thus produced Pure Steam becomes the source steam for the next Effect, un evaporated
water becomes the feed water and this process is repeated in all the remaining Effects
each working at lower temperature and pressure than the one preceding it. Pure Steam
condenses as WFI in each effects and WFI along with the Pure Steam from the last
column is taken to the condenser where it is cooled to 95 C by using cooling water.
9.3 START- UP (AUTO MODE)
Switch ON the Mains
Select Auto mode with the switch provided on Panel board
Check the setting parameter
Press START from HMI
Check priming of the pump
Open the Boiler steam stop valve
Close the column condensate drain valve & open column condensate drain bypass
valve
Wait till the steam is coming out from column condensate drain bypass valve
Open the column condensate drain valve (BV2) & Close column condensate drain
bypass valve
Close column drain valve
Close all column sample taking valves
Wait till the Feed pump gets ON
Set the Feed water flow rate 1/3 of the requirement
(Refer GA DRG / Consumption data sheet on the plant.)
Wait till the Distillate starts coming out
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT

DRD : Page 17 of 50
Design Review
Set the Feed water flow rate as per the consumption data
(Refer GA DRG / consumption data sheet on the plant.
Set the Cooling water flow rate as per the consumption data
(Refer GA DRG / consumption data sheet on the plant.)
Y HOW TO STOP MACHINE
Close the Boiler steam stop valve
Wait till the Feed pump get OFF
Press STOP from HMI
After reducing distill water temp. to low set point Cooling pump will get OFF.
Drain the condensate through condensate by pass valve
Open all manually operated valves to drain out the water remain there after the plant is
stopped. After some time, Close the all manually operated valves
Switch OFF main panel.
9.4 START- UP (MANUAL MODE)
Switch ON the Mains
Select manual mode with the switch provided on Panel board
At that time PLC display will be OFF.
Open the Boiler steam stop valve
Close the column condensate drain valve & open column condensate drain bypass
valve
Wait till the steam is coming out from column condensate drain bypass valve
Open the column condensate drain valve & Close column condensate drain bypass
valve
Close column drain valve
Close all column sample taking valves
Check priming of the pump
2
After reaching boiler steam pressure 3 Kg/cm start the Feed pump
Set the Feed water flow rate 1/3 of the requirement.
(Refer GA DRG / Consumption data sheet on the plant.)
Wait till the Distillate starts coming out
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT

DRD : Page 18 of 50
Design Review
Set the Feed water flow rate as per the consumption data
When temp. of distillate reaches more than 60 C start cooling pump.

Set the Cooling water flow rate as per the consumption data
Control last column level through purging valve
Control Dumping valve through manual switch (provided on panel) as per
conductivity of distill water (less than 1 s/cm) & temperature of boiler steam (it should
more than 143 C) & distillate (it should be more than 60C)
Control the venting valve periodically 300 sec OFF & 10 sec ON.
Y HOW TO STOP MACHINE
Close the Boiler steam stop valve
Stop Feed pump after boiler steam pressure reduce 3 Kg/cm
After reducing distill water temp. to low set point, Stop Cooling pump
Drain the condensate through condensate by pass valve
Open all manually operated valves to drain out all remaining water then plant will stop.
After some time, Close the all manually operated valves
Switch OFF the Main
9.5 FACTORY SETTING
Sr No
INSTRUMENT
SETTING PARAMETER
1.
Safety Valve for Plant Steam
6.1 Kg/Cm
2.
Air Pressure Switch
3 Kg/Cm
3.
Air pressure regulator
4 Kg/Cm
4.
Feed water outlet pressure switch
7 Kg/Cm
5.
Feed water inlet pressure switch
1 Kg/Cm
6.
Cooling water inlet pressure switch
1 Kg/Cm
7.
Overload Relay
As per pump selection
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT

DRD : Page 19 of 50
Design Review
9.6 LIST OF THE AUDIO / VISUAL ALARMS

In case of any fault in the plant, fault indication lamp will get on
Sr.No.
List of the Alarm
Boiler Steam Temperature Low
Dumping ON (WFI Rejection)
Feed Water inlet pressure low
Feed Pump and control valve OFF
Feed water pressure low
Indication
Feed Water Conductivity High
Insufficient Evaporation
Last Column Purging Problem
Cooling water temp. High
Indication, Alarm
Air Pressure low
Feed Pump ,control valve and Dumping ON
Result
(WFI Rejection)
9
WFI Temp. Low
Dumping ON, Cooling Pump OFF, Venting

Valve ON.
10
WFI Temp. High
Indication, Alarm
11
WFI conductivity high
Dumping ON (WFI Rejection)
12
Auxiliary OFF
Feed pump and control valve OFF
13
Emergency OFF
Cooling pump, & dumping will on and other

valves will close.
14
Process OK
Not applicable
M/s ABC PHARMA PVT.

LTD.

PLANT
Pharmal
ab
DRD : Page 20 of 50
Design Review
9.7 PLC DETAILS
Make : Mitsubishi
HMI
With Real time tracking
5.7 Colour Touch screen Display
: E-1061
NOTE: As per continuous up gradation of programme and process, it may be possible

there is slight variation in the list given below. This list is given to understand basic
requirement of PLC
DIGITAL INPUT DETAILS
INPUT NO. OF PLC
RELATED INPUT FROM RELAY / INSTRUMENT
IN0
DISTILL WATER LEVEL HIGH
IN1
F.W. INLET PRESS. S/W
IN2
FIRST COLUMN LEVEL S/W
IN3
LAST COLUMN LEVEL S/W
IN4
AIR PRESSURE S/W
IN5
FEED WATER PRESS. S/W
IN6
EMERGENCY STOP
IN7
FEED PUMP O/L
IN8
COOLING PUMP O/L
IN9
IN10
COOLING WATER PRESS. S/W

SPARE
IN11
SPARE
IN12
SPARE
IN13
SPARE
QR-731-05,
Rev. 00
Page 20 of 50
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT

DRD : Page 21 of 50
Design Review
OUTPUT DETAILS
OUTPUT NO. OF PLC
RELATED OUTPUT FROM RELAY/INSTRUMENT
OUT0
COOLING PUMP
OUT1
FEED PUMP
OUT2
VENTING VALVE
OUT3
PURGING VALVE
OUT4
DUMPING VALVE
OUT5
BUZZER
OUT6
SPARE
OUT7
SPARE
OUT8
SPARE
OUT9
SPARE
ANALOG INPUT DETAILS

CHANNEL NO. OF PLC
CHANNEL 1
RELATED ANALOG INPUT FROM RELAY/INSTRUMENT

F. W.CONDUCTIVITY
CHANNEL 2
W.F.I. CONDUCTIVITY
CHANNEL 3
SPARE
CHANNEL 4
SPARE
RTD INPUT DETAILS:CHANNEL NO. OF PLC
RELATED ANALOG OUTPUT FROM
CHANNEL 1
RELAY/INSTRUMENT
BOILER STEAM TEMP.
CHANNEL 2
COOLING WATER TEMP.
CHANNEL 3
W.F.I. TEMPERATURE
CHANNEL 4
SPARE
QR-731-05,
Rev. 00
Page 21 of 50
M/s ABC PHARMA PVT.

LTD.

PLANT
Design Review
Pharmal
ab
DRD : Page 22 of 50
9.8 PASSWORD & PARAMETERS :

Some of the following values need to be set. There are some password levels to enter in
to particular screen to set parameters.
Y Level 1 (4 digit
password)
To enter user name & password by key. Level 1 password is made for operator to
change the parameters below
PRE HEATING TIME
INITIAL HOOTER OFF TIME
PARA. PRINT TIME
PRINTING TIME
PARA. PRINT DISABLE
Y Level 2 (4 digit password)

To enter the pass word & Confirm password by key. Level 2 passwords is made for
supervisor to change/set the parameters for
PRE HEATING TIME
PARA. PRINT TIME
PRINTING TIME
PARA. PRINT DISABLE
BOILER STEAM TEMP. (SET)
BOILER STEAM TEMP. (LOW)
W.F.I. TEMP. (LOW)
W.F.I. TEMP. (HIGH)
COOLING WATER TEMP.
F. W. CONDUCTIVITY
W.F.I. CONDUCTIVITY
VENT OFF TIME
M/s ABC PHARMA PVT.

LTD.

PLANT
Pharmal
ab
DRD : Page 23 of 50
Design Review
VENT ON TIME
INITIAL DRAIN TIME
PURGING TIME
PURGING FAULT ON TIME
PURGING FAULT OFF TIME
DRAIN TIME
SHUTDOWN TIME
Y Level 3 (4 digit
password)
To enter the pass word & Confirm password by key. Level 3 passwords is made for
supervisor to change/set the parameters for
AS PER LEVEL 1 & 2
DEADBAND
: BOILER STEAM TEMP. DEADBAND

: W.F.I. TEMP. DEADBAND
SET RANGE
: BOI. STEAM TEMP.

: W.F.I. TEMP.
: C. W. TEMP.
: F.W. CONDUCT.
: W.F.I. CONDUCT.
BYPASS
: BOILER STEAM TEMPERATURE

: W.F.I. TEMPERATURE
: COOLING WATER TEMPERATURE
: F. W. CONDUCTIVITY
: W.F.I. CONDUCTIVITY
CLOCK
M/s ABC PHARMA PVT.

LTD.

PLANT
Pharmal
ab
DRD : Page 24 of 50
Design Review
9.9 SETTABLE PARAMETER RANGE

PARAMETER
RANGE
PRE HEATING TIME
( 60 - 600 Sec )
( 60 - 600 Sec )
PARA.PRINT TIME
( 15 - 999 Min )
PRINTING TIME
( 15 - 600 Sec )
PARA.PRINT DISABLE
YES/NO
BOILER STEAM TEMP. (SET)
( 143.0 200.0 C )
BOILER STEAM TEMP. (LOW)
( 120.0 150.0 C )
W.F.I. TEMP. (LOW)
( 70.0 98.0 C )
W.F.I. TEMP. (HIGH)
( 80.0 110.0 C )
COOLING WATER TEMP.
( 70.0 110.0 C )
F.W. CONDUCTIVITY
( 0.00 20.00 us/cm )
W.F.I. CONDUCTIVITY
( 0.00 20.00 us/cm )
VENT OFF TIME
( 10 - 900 Sec )
VENT ON TIME
( 10 - 90 Sec )
INITIAL DRAIN TIME
( 0 - 3000 Sec )
PURGING TIME
( 2 90 Sec )
( 1 499 Min )
( 1 - 499 Min )
DRAIN TIME
( 10 - 300 Sec )
SHUTDOWN TIME
( 10 600 Sec )
COOLING PUMP OFF TIME
( 1 60 Min )
Note: Initial drain time is time for which 3-way dumping valve will dump the water (reject
the water), irrespective of quality of the water for safety reasons. This initial time is time
when plant is started every time after its shutdown.
M/s ABC PHARMA PVT.

LTD.

PLANT
Pharmal
ab
DRD : Page 25 of 50
Design Review
9.10 OPERATION: DETAILED

NOTE : Display of HMI can change slightly than specified as per PLC programming
requirement.
The WFI Generation Plant is working on the principle of inter stage heat exchanger (reuse
of energy) drastically reduce the consumption of heat energy and cooling water.
st
Open the Boiler steam stop valve (GV1) and allow Boiler Steam to enter in to the 1
Column. Now steam condensate with impurities drain out through boiler steam condensate
drain bypass valve (BV3), so steam trap will not get chock up. As soon as clean steam
starts to come out from column condensate drain valve close the same and open boiler
steam condensate drain valve (BV2).
The steam will now enter the heat exchanger of the first column (CA1). The condensate
will now start being discharged from the steam trap (ST1). The discharging function of the
steam trap will be automatic.
The temperature of the input steam will be sensed by temperature sensor (TS1) & can be
seen on HMI. Pressure of boiler steam can be seen on pressure gauge (PG1). The
temperature with reference to pressure is shown in following table:
INPUT STEAM PRESSURE
TEMPERATURE
3 Kg/Cm
143 C
4 Kg/Cm
5 Kg/Cm
152 C
o
159 C
6 Kg/Cm
165 C
o
o
The input steam pressure should be regulated by means of Boiler steam stop valve (GV1)
to obtain the set temperature/pressure. Any deviation in temperature will be indicated on
PLC display BOILER STEAM TEMP.LOW with a hooting sound. Press ACK
M/s ABC PHARMA PVT.

LTD.
Design Review
Pharmal
ab

PLANT

DRD : Page 26 of 50
acknowledges Key. Rectify the problem. When fault will go away automatically and it show
PROCESS OK.
After completion of preheating time (Normally it is 3 minutes), Feed Pump (P1) will start
automatically. If feed pump gets off, check the pump related interlocking. As soon as feed
water pump starts, slowly open the Feed Water flow control Valve such that the water flow
meter (FI1) will indicate the flow of water at about 1/3 of the plant capacity, so that
evaporation in first column will take place properly & prevents extra accumulation of Feed
water in first column, and that will preheat all columns rapidly. Close the Feed water drain
out ball valve (BV1).
Please check that the Feed water Pressure on feed water pressure gauge (PG2) is more
than the set steam pressure as seen on boiler steam pressure gauge (PG1). The feed
water will now pass through the cooler assembly 1 (CLA1). It will be pre heated through
pure steam. It will pass through successive Preheater last to the first which may be inbuilt
or separate as per design.
The Feed water will now enter in to the first column (CA1) from top & some of it will
convert in to the steam. The evaporated vapor will rise upward and un-evaporated Feed
water which is collected at the bottom will go to the next column under pressure.
NOTE:
In the initial stage, there might be some chances of extra accumulation of un-evaporated
feed water in the first column. In that case, drain out the excess water by operating manual
drain valve (BV1). The predetermined level of water is very important for the correct
functioning of the distillation process. In case this water level rises during the distillation
process, the level sensor (LS1) fitted in first column will automatically switch off the feed
water pump (P1) supply preventing further accumulation, and when the water level
is
reduced by evaporation, the pump (P1) will restart functioning automatically. This function
is thus fully automatic (as described below) and by any chance, the pump continues to go
on and that the water level does not reduce. Check for the diagnostics.
M/s ABC PHARMA PVT.

LTD.

PLANT
Pharmal
ab
DRD : Page 27 of 50
Design Review
Now feed pump (P1) is running & if there is a problem of Low Boiler Steam Temperature
(Sensed by Temperature sensor TS1), at this stage feed pump (P1) will not stops
directly it shows fault indication by hooter & message BOILER STEAM TEMP.LOW
problem. Now due to low steam problem, the efficiency of evaporation of Feed water in
first column reduced, which result to start accumulation in same column. As soon as water
reaches up to level sensor (LS1), & PLC will get signal through level sensor, & pump (P1)
will stop (As above condition not satisfied). There are also accumulation takes place due
to following reason
IF THE FEED WATER FLOW IS HIGHER THAN SPECIFIED
The reason might be insufficient heat compared to the flow of feed water. The Feed Water
flow should be in relation to its continuous evaporation. This can be activated by
controlling the feed water supply and by checking the level of evaporated water in the
bottom of the first column.
IF STEAM TRAP IS MALFUNCTIONING
st
If steam trap (ST1) provided at the bottom of 1 condenser is malfunctioning, then it will
not allow condensed water of boiler steam to go out or will allow steam to go out to drain.
In both the cases effective energy available for heat transfer will be less & hence water
level in first column rises, which in turn gives signal to PLC through sensor (LS1) &
eventually results in stopping of the Feed pump (P1).
SCALE FORMATION IN THE COLUMN TUBES.
After prolonged use, impurities in the Feed water will start depositing inside the tubes
(Because Feed water is passing through these tubes). These impurities will form a layer in
the inside surface of these tubes, which in turn reduces heat transfer efficiency of the unit.
Because of low heat transfer, less amount of Feed water will be converted into the steam
& more amount of Feed water will be accumulated at the bottom of the column in the form
of water. As more amount of water is coming, Water level will rise. This in turn gives signal
to PLC through sensor (LS1) & eventually results in stopping of the Feed pump (P1).
M/s ABC PHARMA PVT.

LTD.

PLANT
Design Review
Pharmal
ab
DRD : Page 28 of 50
The rising vapor in the column is made to pass through a precisely designed Spiral guide
resulting in a high centrifugal force. This will eliminate effectively the entrained
water
droplets and only the pure vapor will travel further to the Heat Exchanger of the Second
column.
Thus the un-evaporate portion of Feed Water and Pure vapor of the first column (CA1) is
passed respectively to the tubes and steam chest of the heat exchanger of the second
column (CA2). This will result into the transformation of the feed water partially into vapor
and partially into evaporated feed water, in the second column.
The processes of evaporation in the consecutive columns are similar. The condensate of
nd
the 2 , to last columns, which is pure Pyrogene free distilled water, is Interconnected and
made to go up in the cooler assembly 1 (CLA1) finally. The vapor generated in the last
column is also passed to the cooler assembly 1 (CLA1). It may be noted that the vapor of
the last column and the condensate of the columns are at an elevated temperature. This,
in turn, pre-heats the incoming feed water and comes out as distilled water from the cooler
assembly 2 (CLA2) and same is visible through Sight glass. Individual columns are with
sample point for W.F.I.
The un-evaporated Feed water with impurities will accumulate in the last column. When
the level sensor (LS2) will be operated, Purging pneumatic valve (PN1) will operate
automatically to purge out un-evaporated feed water from the last column.
This purged water is approximately 10-15% of the feed water. It is essential that the unevaporated water must be purged out to remove the dissolved and un-dissolved
impurities. It should be ensured that there is steady flow of the purged water, depending
on the amount of feed water of feed water and temperature.
If the water from the last column not drains continuously up to 3 minutes, then Feed pump
(P1) will stop automatically. After that PLC display shows fault PURGING PROBLEM.
Now check the inter locking for PURGING PROBLEM & check remedies to short out the
purging problem
M/s ABC PHARMA PVT.

LTD.

PLANT
Design Review
Pharmal
ab
DRD : Page 29 of 50
NOTE:
You can draw 10 to 15% pure steam of total plant capacity at the set pressure from
the second column pure steam outlet.
Initial Feed Water Flow Valve (Applicable for model inclusive & onwards of WS2000) will
operate parallel to Feed Water pump (P1). Adjust the flow in such a way that there will not
be any water accumulation in first column (As initial stage there is no pre-heating of Feed
water ) & plant runs smoothly.
As soon as fault comes, BUZZER will gives signal to attendant. Press the acknowledge
button & rectify the problem, With respect to water accumulation in last column. If there is
no water accumulation or input is not coming due to any reason & it remains off
continuously for more than 8 minutes then feed pump (P1) will stop automatically. After
that PLC display will show fault- PURGING PROBLEM. Check the reason why PLC not
getting signal. Rectify the same, for resting of feed pump press acknowledges push button
& release the same.
DUMPING VALVE (DV1)- will operate with respect to low temperature as well as high.
Conductivity of W.F.I. (During gearing up from Start mode, dumping valve will dump the
water as per time set in Initial Dumping time irrespective of W.F.I Temperature (Sensed by
temperature sensor TS2) & Conductivity (Sensed by Conductivity Sensor CS2). After
completion of initial dumping time, dumping valve (DV1) will come in operation & Operate
as per temperature & Conductivity of W.F.I) initially dumping valve will dump the W.F.I for
set timer of Initial dumping time. Also dumping valve rejects W.F.I if boiler steam
temperature, is low than set value & air pr. Lower than set value (Set on Air Pressure
Switch PS1).
W.F.I will now start flowing out and can be seen through the sight glass. Gradually the
temperature of W.F.I increasing and same will be dumped out from rejection line through
dumping valve until the temperature of W.F.I is below set point. Normally it should be
70C. After that W.F.I will come out from main out let.
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT
Design Review

DRD : Page 30 of 50
A conductivity sensor (CS2) is provided in the line of W.F.I. Initially on account of higher
conductivity the dumping valve fitted in line will automatically reject the
W.F.I till the required level of conductivity will be achieved.
COOLING PUMP (P2) will start as soon as the temperature of W.F.I will reach up to set
level (i.e. 70C). At the time of initial starting the temperature of W.F.I. is low, hence it is
not require cooling down and at this stage Cooling Pump (P2) should be in stop position
otherwise there will be wastage of W.F.I as well as cooling water and energy.
When plant stop, still cooling pump (P2) will remain ON till the W.F.I temp, will reach up to
set W.F.I temp. Low point
Now increase and set the flow of feed water and cooling water by operating feed water In
(DP2) and cooling water In (NV1) valves respectively, in steps till the quantum as per table
will be archived. Set the flow rate such that the temperatures of W.F.I remain below 98C.
It should be maintain less than 100 C
Within 5-15 minutes the system will get set and all the controls will work in order.
For collecting sample of distilled water open sampling valve and collect the sample.
AIR VENT VALVE (PN2) It will remain ON till the W.F.I temperature more than or equal
to low set point (i.e. 70C).Air vent valve will operate automatically as per timer set in
program. It will operate for set time at set interval..
QR-731-05,
Rev. 00
Page 30 of 50
M/s ABC PHARMA PVT.

LTD.

PLANT
Design Review
Pharmal
ab
DRD : Page 31 of 50
9.11 INTER LOCKING

Y
INTER LOCKING FOR FEED PUMP (P1) AND CONTROL VALVE (PN4) (IF IN
SCOPE): Feed pump will stop automatically with
respect to following controls.
Emergency Stop
Air Pressure Low
Boiler steam temperature Low (After 5 minutes Feed pump will stop)
Conductivity Of Feed Water High
Insufficient Evaporation
Initial heating time (After Boiler Steam Temp. will down as per Boiler Steam
Temp. (Low) value)
Insufficient Feed Water
Distill Water Level High
Purging On Problem
Purging Off Problem
Feed Pump Overload
INTER LOCKING FOR COOLING PUMP (P2) AND CONTROL VALVE (PN5) (IF IN
SCOPE) : Cooling pump will stop automatically with respect to following controls.
Cooling Pump Over Load
Low W.F.I. Temperature
Emergency Stop
Air Pressure Low
QR-731-05,
Rev. 00
Page 31 of 50
M/s ABC PHARMA PVT.

LTD.

PLANT
Design Review
Pharmal
ab
DRD : Page 32 of 50
INTER LOCKING FOR PNEUMATIC VALVE

DUMPING VALVE (DV1) : Dumping Valve will get ON automatically with respect to
following controls & will ON in Healthy condition.
Initial Drain Time
Low Boiler Steam Temp.
Low W.F.I. Temperature
Conductivity Of W.F.I. High
Emergency stop
Air Pressure Low
AIR VENT VALVE (PN2) :
When the W.F.I temperature low than the set value Air Vent Valve will ON
Air vent valve will operate automatically as per timer set in program. It will
operates for set time at set interval
PURGING VALVE (PN1) : Purging valve will operate on water level accumulate in
last column.
Last column level High
Purging hold time
Shutdown Timer after Process Stop
9.12 SAFETY VALVE SETTING

Y BOILER STEAM LINE SAFETY VALVE (SV1)
Increase pressure than set value & check at steam pressure gauge, safety valve
gets open
Decrease the steam pressure than set value, safety valve gets close
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT

DRD : Page 33 of 50
Design Review
9.13 PRINTING FORMAT :
OPERATION REPORT FOR MULTI COLUMN DISTILLATION PLANT
COMPANY NAME : XXXXXXXXXXXXXXXXX.

JOB NO.
: XXXXXXX
DATE
: DD/MM/YY
TIME
: HRS/MIN/SEC
SET PARAMETER AS FOLLOWS:

BOILER STEAM TEMP (SET)
143.0 C
W.F.I TEMP. (LOW)
070.0 C
W.F.I TEMP. (HIGH)
098.0 C
COOLING WATER TEMP.
098.0 C
W.F.I CONDUCTIVITY
1.00 us/cm
FEED WATER CONDUCTIVITY
5.00 us/cm
PRE HEATING TIME
060 Sec
VENT OFF TIME
300 Sec
VENT ON TIME
010 Sec
INITIAL DRAIN TIME
060 Sec
PURGING TIME
030 Sec
03 Min
05 Min
060 Sec
PRINTING TIME
060 Sec
PARAMETER PRINT TIME
015 Min
PARA. PRINT DISABLE
YES
BOILER STEAM TEMP (LOW)
120.0 C
DRAIN TIME
030 Sec
SHUTDOWN TIME
120 Sec
M/s ABC PHARMA PVT.

LTD.

PLANT
TIME

DRD : Page 34 of 50
Design Review
DATE
Pharmal
ab
TEMPERATURE in DegC
BOILER
COOLING
STEAM
WATER
W.F.I
COND. in us/cm
FEED
WATER
W.F.I
03/09/07
15:25:02
145.3
97.5
98.3
4.55
0.75
03/09/07
15:26.02
145.7
97.6
98.5
4.55
0.75
M/s ABC PHARMA PVT.

LTD.

PLANT
Design Review
Pharmal
ab
DRD : Page 35 of 50
10.1 LIMITING CONDITIONS FOR PERFORMANCE OF EQUIPMENT
Wet Steam & Low Flow rate of the Boiler Steam will give the Evaporation
Problem.
Poor Quality of Feed Water Supplied will affect the quality of WFI generated
Higher Feed Water flow rate will give the Evaporation Problem.
Malfunctioning of Air Vent will affect the quality of WFI.
To retain the memory, power should be given to PLC & HMI at least once in 3
months after dispatch date.
M/s ABC PHARMA PVT.

LTD.

PLANT
Design Review
Pharmal
ab
DRD : Page 36 of 50
11.1 INSTALLATION AND START UP

A. CUSTOMER RESPONSIBILITY
Unloading of the WFI PLANT from the truck.
Movement of the WFI PLANT through the facility to the final site.
WFI PLANT entrance size to be provided by customer should be sufficient to

pass the packing box through the same. Refer technical specification for box
size of machine.
Unpacking of boxes containing dismantle parts should be done in presence of

Pharmalab engineers.
Positioning and leveling of WFI PLANT
Supplied wire conduit from the facilities main feed to the machine cabinet.
Connection of the pneumatics.
Supplied exhaust ductwork /drain and utility connection system.
B. ASSISTANCE BY PHARMALAB ENGINEERS
Pharmalab engineer will assist for proper Utility and drain connection at battery
limit to WFI PLANT.
Proper alignment of machine.
C. START UP
Pharmalab can provide a factory trained service person to assist with the
successful start-up of the WFI PLANT. Our factory trained person will be on site
in your facility to assist with the proper start-up and training of your personnel in
the operation and maintenance of the WFI PLANT. Typically, two (2) days are
used for system check-out and one (1) day for training.
M/s ABC PHARMA PVT.

LTD.

PLANT
Design Review
Pharmal
ab
DRD : Page 37 of 50
Y The WFI PLANT start-up includes the following essential tasks:
Inspect physical condition of WFI PLANT:
Electrical connections.
Pneumatic connection.
Meet with maintenance, Q/A, validation and production personnel.
Check facilities and support.
Check rotational direction where ever it is applicable.
Check out interconnect wiring if control cabinet is remotely mounted.
Operator training as described below. This will include sample run of

WFI
PLANT.
D. TRAINING
Training is a standard part of WFI PLANT installation and start-up includes such
basic issues as theory of operation, user interface and configuration. As such,
Pharmalab engineer will work with your production and maintenance personnel to
schedule appropriate personnel to take part in the initial start-up. This is
very
important because this is the time when actual issues will arise and be solved. It is
a real life troubleshooting experience and cannot be duplicated in the classroom.
Usually, we ask for one mechanical and one electrical maintenance technician to
stay with the project from beginning to end. Operators are trained so that they can
perform operation qualification after installation. Usually production training does
not take more than a day.
Often, customers will request additional training and Pharmalab is very comfortable
in working with you to determine the extent of the training and collateral course
materials required at cost.
M/s ABC PHARMA PVT.

LTD.

PLANT

DRD : Page 38 of 50
Design Review
12.0 IDENTIFICATION
CALIBRATION
Pharmal
ab
OF COMPONENTS FOR CERTIFICATION
Sr. No.
Name
Document
12.1
Pump
Compliance Certificate
12.2
Pneumatic Valve
Compliance Certificate
12.3
Pressure Gauges
Calibration Certificate
12.4
Temperature Sensor
12.5
Pressure Switch
Test Certificate
12.6
Safety Valve
Test Certificate
12.7
Ball Valves
Test Certificate
12.8
Non Return Valve
Test Certificate
12.9
Diaphragm Valve ( Manually Operated )
Test Certificate
12.10
Steam Globe Valve
Test Certificate
12.11
Steam Trap
Test Certificate
12.12
Dual Conductivity Meter & Conductivity Sensor
12.13
Material of Construction (For Column Assly & Pipe

Line )
&
Test Certificate
12.14
Level Controller
Test Certificate
12.15
Disposable Vent Filter
Test Certificate
.
NOTE: Pharmalab will provide test certificates of bought out components which are
received form supplier and same will be as per suppliers standard format.
Customer has to inform at the time placing order if they need any more certification.
M/s ABC PHARMA PVT.

LTD.

PLANT
Pharmal
ab
DRD : Page 39 of 50
Design Review
13.0 LIST OF COMPONENTS

Sr. No
13.1
13.2
13.3
13.4
Component
Specifications
Feed Pump (P
Make
Grundfos
& I Tag No. P1)
Model
CRN 3 -12
Rated Head
57 meter
Rated flow rate
3000 LPH
MOC
SS316
Mechanical seal
SiC/SiC
Motor
3 Phase, 415 V, 2853 RPM, 1.10 Kw
Qty
01
Location
At the inlet of the feed water
Cooling Pump
Make
Grundfos
(P & I Tag No.
Model
CHI 2-20
P2)
Rated Head
13 meter
Rated flow rate
2500 LPH
MOC
SS316
Mechanical seal
SiC/SiC
Motor
3 Phase, 415 V, 2853 RPM,0.35 Kw
Qty
01
Location
At the inlet of the cooling water
Non return valve Make
Alfa Laval (LKM)
(P & I Tag No.
Model
LKC - 2
NRV3)
MOC
SS 316L
Size
DN 25 (Triclover End Connection)
Qty
01
Location
At the cooler air vent line (NRV3)
Non Return
Make
VB or Equivalent
Valve (P & I Tag
Size
25 mm
No. NRV6)
MOC
Brass
Qty
01
Location
At the WFI Rejection Line (NRV6)
M/s ABC PHARMA PVT.

LTD.

PLANT
13.6
13.7

DRD : Page 40 of 50
Design Review
13.5
Pharmal
ab
Sampling Valve
Make
Pharmalab
(Diaphragm
Model
DN 20
Type) (P & I Tag
MOC
SS 316L
No. SM2, SM3,
Diaphragm
Silicon
SM4 & SM5)
Size
(Butt End connection)
Operation
Manual
Qty
04
Location
WFI line from condenser to condenser
WFI Sampling
Make
Pharmalab
Valve
Model
DN 38
(Diaphragm
MOC
SS 316L
Type) (P & I Tag
Size
DN-38 (Butt End connection)
No. SM1)
Diaphragm
Silicon
Operation
Manual
Qty
01
Location
At the outlet WFI line sampling point
Variable area
Make
George Fischer
flow meter (P &
Model
SK-73
I Tag No. FI1 &

FI2)
Tube - Polyamide
MOC
Float PVDF
Gaskets - EPDM
13.8
2 Way
Range
300-3000 LPH
Qty
02
Location 1
At discharge side of feed pump (FI1)
Location 2
At discharge side of cooling pump (FI2)
Make
Burkert
Pneumatic valve Model

(P & I Tag No.
MOC of Working
PN4 & PN5)
parts
2 way
SS 316L
MOC of Body
SS 316L
Type
Piston Actuated
Size
DN 20 / 25 (Butt End connection)
QR-731-05,
Rev. 00
Page 40 of 50
M/s ABC PHARMA PVT.

LTD.

PLANT
2 Way
Seal
P.T.F.E
Actuator
Single Acting (Spring Return)
Qty
02
Location 1
At Feed Water Inlet line (PN4)
Location 2
At cooler Water Inlet line (PN5)
Make
Burkert
Pneumatic valve Model

(P & I Tag No.
MOC of Working
PN1 & PN2)
parts
13.10
2 way
SS 316L
MOC of Body
SS 316L
Type
Piston Actuated
Size
DN 15 / 20 (Butt End connection)
Seal
P.T.F.E
Actuator
Single Acting (Spring Return)
Qty
02
Location 1
At Last Column Purging Line (PN1)
Location 2
At cooler air vent line (PN2)
Globe valve (P
Make
Shakti / Zoloto
& I Tag No.
Model
Non IBR
GV1)
MOC of Working
parts
13.11

DRD : Page 41 of 50
Design Review
13.9
Pharmal
ab
SS 410
MOC of Body
Gun Metal
Type
Globe valve
Size
40 mm
Seat
Teflon
End Connection
Flange end as per ASA 150 #
Operation
Manual
Qty
01
Location
At inlet of the plant steam
Diaphragm
Make
Crane Process (Sounders) or equivalent
Valve (P & I Tag
Model
DN 40
No. DP1)
MOC
SS 316L
QR-731-05,
Rev. 00
Page 41 of 50
M/s ABC PHARMA PVT.

LTD.

PLANT
13.13
13.14
Diaphragm
PTFE / EPM
Size
DN-40 (Triclover End Connection)
Operation
Manual
Qty
01
Location
At the WFI outlet line
Diaphragm
Make
Crane Process (Sounders) or equivalent
Valve (P & I Tag
Model
DN 25
No. DP2)
MOC
SS 316L
Diaphragm
PTFE / EPM
Size
Operation
Manual
Qty
01
Location
At the outlet of feed pump
Air regulator
Make
SMC / FESTO
(Filter,
Range
0 16 Kg / Cm
Regulator,
Size
Lubricator) (P &
Qty
01
I Tag No. SU1)
Location
At the Inlet of the compressed air
Steam Trap (P
Make
Spirax
& I Tag No. ST1

& ST2)
Model
Type
Max. working
pressure
Max working
temperature
BPT-21,15NB (Threaded End

Connection)
Balanced pressure thermostatic trap
21 Kg / Cm
242 C
Qty
02
Location 1
At First column air vent line (ST2)
Location 2
13.15

DRD : Page 42 of 50
Design Review
13.12
Pharmal
ab
At Boiler Steam Condensate line of first

condenser (ST1)
Safety valve (P
Make
Spirax
& I Tag No.
Model
SV-11
M/s ABC PHARMA PVT.

LTD.

PLANT
13.16
Size
(Threaded End Connection)
Type
Spring loaded
Range
75-125 Psi
Qty
01
Location
At inlet of the plant steam line
Ball Valves (P &
Make
Shakti
I Tag No. BV1,
Model
BV2 & BV3)
MOC
SS 316L
Size
(Butt End connection)
Type
3 Piece ball valve
Seal
PTFE
Qty
03
Location 1
Location 2
13.17
13.18

DRD : Page 43 of 50
Design Review
SV1)
Pharmal
ab
At plant steam condensate drain

through first column (BV2)
At plant steam condensate drain by
pass to steam trap (BV3)
Location 3
First column drain (BV1)
Needle valve (P
Make
Shakti
& I Tag No.
Model
NV1)
Body material
SS 316L
Operation
Manual
End connection
BSP Female
Qty
01
Location
At the cooling water line
3 way Sanitary
Make
Pharmalab / Cipriani H. V. P. Ltd.
dumping valve
Model
DN 40
(P & I Tag No.
MOC
SS 316L (Body & Wetted Parts)
DV1)
Size
Gasket
Silicon
Operation
Pneumatic
Qty
01
Location
At the outlet WFI line
M/s ABC PHARMA PVT.

LTD.

PLANT

DRD : Page 44 of 50
Design Review
13.19
Pharmal
ab
Pressure Gauge
Make
Warree
(P & I Tag No.
Model
PG1)
MOC
SS 316 (Contact parts) (Threaded End

Connection)
13.20
13.21
Dial size
100 mm
Type
Bourdon tube
Range
0-14 / 016 Kg/cm
Least count
0.2 Kg/cm
Mounting
Direct Mounting
Qty
01
Location
At plant steam line
Sanitary
Make
Warree
Pressure Gauge
Model
Glycerin filled (P
MOC
SS 316 (Contact parts)
& I Tag No.
Dial size
100 mm
PG2)
Type
Bourdon tube
Range
0-14 / 0-16 Kg/cm
Least count
0.2 Kg/cm
Mounting
Sanitary (Triclover End Connection)
Dampening liquid
Glycerin
Qty
01
Location 1
Model
At discharge side of feed pump

Automatic
Enclosure
Rittal
Panel Location
On Skid
Size
800 mm W x 1000mm H x 300 mm D
Contactor
L&T
Over load relay
L&T
Control Panel
Main power
supply On / Off
Sulzer
switch
Transformer
BHATT MAGNATIC / NARMADA
ELCB + MCB
HAGGER
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT

DRD : Page 45 of 50
Design Review
Emergency off
Push button
Auto/manual
Rotary switch
Telemechanic
Sulzer
PLC
Mitsubishi
Display
E-1061 HMI 5.7 colour touchscreen
On/Off Switch
venting valve
purging valve
dumping valve
feed pump
cooling pump
Model: 1055-01-10-20-30
Make: Rose mount
Conductivity
Meter
Display :16 Character, Two line

Input : From Conductivity Sensor
Channel : Dual channel
Output: 4-20 mAmp - 2 Nos.
Alarm: Relay type - 3 Nos.
Location: on control panel
13.22
Conductivity
Make
Rose mount
sensor (P & I
Model
403-11-20 (Triclover End Connection)
Tag No. CS1 &
MOC(wetted
CS2)
parts)
Temp. Range
13.23
SS 316L
0 C 105 C (Continuous)
135 C for One hour
Qty
02
Location 1
At inlet of feed pump (CS1)
Location 2
At the WFI outlet line (CS2)
Temperature
Make
Radix
Sensor (P & I
MOC
SS 316L
Tag No. TS1,
Range
-50 C to 200 C
TS2 & TS3)
Type / Class
PT 100 / A
Qty
01
M/s ABC PHARMA PVT.

LTD.

PLANT
13.25
Connection
Triclover
Location 1
At the Boiler steam inlet line (TS1)
Location 2
At the WFI water outlet line (TS2)
Location 3
At the cooling water outlet line (TS3)
Sanitary
Make
Orion
Pressure switch
MOC
SS 316L (Triclover End Connection)
(P & I Tag No.
Diaphragm
Teflon
PS3)
Range
0.2 -2.6 Bar
Qty
01
Location 1
At inlet of feed water pump (PS3).
Sanitary
Make
Orion
Pressure switch
MOC
SS 316L (Triclover End Connection)
(P & I Tag No.
Diaphragm
Teflon
PS2)
Range
1 -15 Bar
Qty
01
Location
13.26
13.28
At the discharge side of feed pump

(PS2).
Pressure switch
Make
Orion
(P & I Tag No.
MOC
SS 316L
PS5)
Diaphragm
Teflon
Range
0.2-2.6 Bar
Qty
01
Location
13.27

DRD : Page 46 of 50
Design Review
13.24
Pharmal
ab
At the suction side of cooling pump

(PS5).
Pressure switch
Make
Orion
(P & I Tag No.
MOC
Aluminum (Threaded End Connection)
PS1)
Range
0.5-7.0 Bar
Qty
01
Location
At air pressure line
Liquid level
Make
Pune Tectrol
Sensor (P & I
Model
3 TC (Triclover End Connection)
Tag No. LS1 &
MOC
SS 316 L
LS2)
Type
Float type
M/s ABC PHARMA PVT.

LTD.

PLANT
13.30
Qty
02
Location 1
First column (LS1)
Location 2
Last column (LS2)
Disposable Vent Make
Pall
Filter (P & I Tag Model

No. VF1)
Filter Length
KA1PFRP1
Printer

DRD : Page 47 of 50
Design Review
13.29
Pharmal
ab
4.2
Medium
PTFE
Removal Rate
0.2 Micron
Qty
01
Location
At Cooler Air Vent Line (VF1)
Make
EPSON
Model
LX-300, 80 column, Dot Matrix
Qty.
01
Location
Besides Panel Board
M/s ABC PHARMA PVT.

LTD.
Pharmal
ab

PLANT

DRD : Page 48 of 50
Design Review
14.0 LIST OF DRAWINGS

Sr. No
TITLE OF DRAWING
DRAWING NO
REVISION NO.
14.1
G. A Drawing
AC 006 91 09 002
14.2
P & I Diagram
AC 006 93 09 002
15.0 LIST OF DOCUMENTS

Pharmalab will provide following Documents along with the qualification documents for the
equipment.
Sr. No.
TITLE OF DOCUMENT
Stage
15.1
Material Test Certificates
FAT/IQ
15.2
Hydro Test Certificate
FAT/OQ
15.3
Running Trial Certificate
FAT/OQ
15.4
15.5
15.6
15.7
15.8
Operation and Maintenance Manual

(1 Set)
AS BUILT Drawing
Certificates of Bought-out
Components
Factory Acceptance Test Report
16.0 CERTIFICATION
Warranty Certificate by M/s Pharmalab.
IQ
With Dispatch Papers
IQ
IQ
With Dispatch Papers
M/s ABC PHARMA PVT.

LTD.
Design Review
17.0 FINAL REPORT

Summary
Conclusion

PLANT
Pharmal
ab
DRD : Page 49 of 50
M/s ABC PHARMA PVT.

LTD.

PLANT
Pharmal
ab
DRD : Page 50 of 50
Design Review
18.0 APPENDIX
ABBREVIATIONS
FULL FORM
WFI
Water For Injection
MOC
Material Of Construction
TC
Triclover
DR
Design Review
IQ
Installation Qualification
OQ
Operational Qualification
FAT
Factory Acceptance Test
ASME
American Society of Mechanical Engineers
PG/SV
Pressure Gauge/Safety Valve
DTIC
Digital Temperature Indicator & Controller
H.O.D
Head of Department
WFI
Water For Injection
PTFE
Poly Tetra Fluoro Ethylene
TDS
Total Dissolved Solids
PPM
Part Per Million
PPB
Part Per Billion
EU/ML
Endotoxin Unit Per Milliliter
CFM
Cubic Feet Per Minute
KW
Kilo Watt
Hz
Electrical Frequency Unit
HMI
Man Machine Interface
URS
User Required Specification
P.S
Pure Steam
B.S
Boiler Steam
NCGR
Non Condensable Gas Removal
TOC
Total Organic Content
TVC
Total Viable Count
CFU
Colony Forming Unit
[B]
G.A. Drawing, P& I diagram.
Enclosed
QR-731-05,
Rev. 00
Page 50 of 50

DQ - Wfi

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Pharmalab

700 Ltr/hr. WFI GENERATION

700 Ltr/hr. WFI GENERATION PLANT

700 Ltr/hr. WFI GENERATION

Job No.: XXXXRevision: 00

DESIGN REVIEW REPORT APPROVAL

SYSTEM INFORMATION AND PROTOCOL DETAILS

ACCEPTANCE CRITERIA AND RESPONSIBILITIES

BASIS OF DESIGN & ASSUMPTION / VARIATION

GENERAL DESIGN QUALIFICATIONS

TECHNICAL SPECIFICATION (With Respect to Purchase Order)

SYSTEM DESCRIPTION AND OPERATION

LIMITING CONDITIONS FOR PERFORMANCE OF EQUIPMENT

INSTALLATION AND START UP

IDENTIFICATION OF COMPONENTS FOR CERTIFICATION &

700 Ltr/hr. WFI GENERATION

1.0 DESIGN REVIEW REPORT APPROVAL

FOR M/s. Pharmalab

Revision Control (if any)

700 Ltr/hr. WFI GENERATION

2.0 SYSTEM INFORMATION AND PROTOCOL DETAILS

Asst. Manager Design

2.3 Protocol Approval from Customer

700 Ltr/hr. WFI GENERATION

2.4 Objectives of this Protocol

To provide the specifications, operation and installation requirements of the

To specify the Performance basis for acceptance of the WFI PLANT.

2.5 Scope of this Protocol

700 Ltr/hr. WFI GENERATION

3.0 ACCEPTANCE CRITERIA AND RESPONSIBILITIES

: Less than 1.3 s/cm at 25C

: Less than 500 ppb

: Less than 0.250 EU / ml

: Less than 10 cfu/100 ml

: NMT 0.1 PPM

: NMT 0.2 PPM

Installation as per the SAT.

Validation of quality of WFI is in customers scope.

The heads of Project, Engineering, Production and QA/QC (Consultants - if

Customer defined protocol for FAT should be approved by Pharmalab along

700 Ltr/hr. WFI GENERATION

To invite customer for the FAT at Pharmalab, Santej.

Scope of FAT is as follows

Dimension Verification against GA drawing.

Verifications of Material of construction certificates.

Verification of WFI PLANT with P & I Diagram.

Verification of Pressure test certificate.

Factory setting for various Instruments

Verification of calibration certificate of all instruments.

PLC input/output check and testing of all inter locks-safety

700 Ltr/hr. WFI GENERATION

4.0 BASIS OF DESIGN & ASSUMPTION / VARIATION

4.2 Assumptions (Customer is responsible to maintain the Quality of the Utility)

Cooling water outlet temperature will be 90 C to 98 C

M/s ABC PHARMA PVT.

700 Ltr/hr. WFI GENERATION

5.0 GENERAL DESIGN QUALIFICATIONS

To Produce water for injection

Working: 700 LPH at 3 Kg / Cm of Plant steam

Operating Temperature 165 C

Operating Temperature 165 C

M/s ABC PHARMA PVT.

700 Ltr/hr. WFI GENERATION