Pharmalab

700 Ltr/hr. WFI GENERATION

PLANT
Revision: 00

Design Review DRD : Page 1 of 50

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

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Rev. 00
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 Pharmalab
700 Ltr/hr. WFI GENERATION
Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 2 of 50

CONTENT

1.0 DESIGN REVIEW REPORT APPROVAL 3

2.0 SYSTEM INFORMATION AND PROTOCOL DETAILS 4

3.0 ACCEPTANCE CRITERIA AND RESPONSIBILITIES 6

4.0 BASIS OF DESIGN & ASSUMPTION / VARIATION 8

5.0 GENERAL DESIGN QUALIFICATIONS 9

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

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 Pharmalab
. 700 Ltr/hr. WFI GENERATION
PLANT
Revision: 00

Design Review DRD : Page 3 of 50

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

Rev
Pg. No. Point Old Description New Description
No

Checked by .. Approved by
Date Date.

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 Pharmalab
M 700 Ltr/hr. WFI GENERATION
PLANT
Revision: 00

Design Review DRD : Page 4 of 50

2.0 SYSTEM INFORMATION AND PROTOCOL DETAILS

2.1 System Information

Pharmalab
Supplier
Santej Vadsar Road, Village Santej, Taluka Kalol, Dist. Gandhinagar.

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. Name Designation Date

Project
Engineering
Production
QA / QC

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700 Ltr/hr. WFI GENERATION
PLANT
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.

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 Pharmalab
700 Ltr/hr. WFI GENERATION
PLANT
Revision: 00

Design Review DRD : Page 6 of 50

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

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 Pharmalab
700 Ltr/hr. WFI GENERATION
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

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.

b) Operation Qualification

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

Trial Run
Endotoxin Test

c) WFI Flow Rate 700 LPH at 3 kg/cm2 Pressure of Boiler Steam and
Conductivity Test for WFI.

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 Pharmalab
700 Ltr/hr. WFI GENERATION
Job No.: XXXX-
PLANT **
Revision: 00

Design Review 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 the
changes asked by customer, the customer has to amend the Purchase Order &
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.

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 9 of 50

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 Operating Pressure 6 Kg / Cm
column) 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 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
Operating Pressure 6 Kg / Cm
Operating Temperature 165 C
Design pressure 6.5 Kg / Cm
Design Temperature 185 C
MOC - SS 316L seamless Tube
Internal surface finish Mill polished
Outer surface finish - 0.6 Ra, Electro Polished (except 1st

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 10 of 50

condenser)
5.5 Feed Water Shell Side
and Cooling Operating Pressure 1 Kg / Cm
Water Cooler Operating Temperature 100 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 - 1 Set
Tube Side
Operating Pressure 6 Kg / Cm
Operating Temperature 100 C
Design pressure 6.5 Kg / Cm
Design Temperature 185 C
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

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 11 of 50

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 1) 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
Internal finish 0.8 Ra, Electro Polished
Outer finish Mirror, Mechanical polished
3) Cooler air vent line
MOC SS 316L, OD x 1.6 mm thick, ERW
Internal finish 0.8 Ra, Electro Polished
Outer finish Mirror, Mechanical polished
4) Feed water, WFI inter connecting and cooling water line
MOC SS 316L, OD x 1.6 mm thick, ERW
Internal finish 0.8 Ra, Electro Polished
Outer finish Mirror, Mechanical polished
5) Steam line
MOC SS 304, 1.5 NB x SCH 10,
Internal finish Mill polished
Outer finish Mirror, Mechanical polished

5.13 Welding Pipe Line by Orbital Welding wherever technically possible.

Fabricated Parts by TIG welding

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 12 of 50

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 HMI
Emergency Push Button
6.7 Packing Box Size
(Approximately) Main Machine 130 L x 128 W x 60 H
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

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 13 of 50

7.0 UTILITIES REQUIREMENTS

Sr.No Utility Supply Requirement Nozzle

At Min 3 kg/cm2 Max.: 250 Kg/ Hr
pressure and 143 1.5" ASA # 150
7.1 Boiler Steam Min : 175 Kg/Hr
C temperature Flange

Max. : 1150 LPH

At 2 Kg/cm2 Pressure &
7.2 Feed Water Min : 805 LPH 1 Triclover
Ambient Temperature

At 2 kg/cm2 Pressure &

Cooling Max. : 1225 LPH
7.3 Ambient Temperature 1 Triclover
water Min : 860 LPH

At 415 V, 50 Hz, 3
Max: 3 KW
7.4 Electricity Phase + Neutral + N.A.
Earthing
Compressed BSP-Female
7.5 At 6 Kg/cm2 Pressure 5 CFM
Air Thread
1 Triclover to
7.6 WFI outlet ---- ---- suit 1.5 OD
Pipe
1.5 BSP
7.7 Header Drain ---- ----
Female thread
Header Air 1 BSP Female
7.8 ---- ----
Vent thread

To retain the memory, power should be given to PLC & HMI at least once in 3 months
after dispatch date.

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 14 of 50

8.0 SAFETY FEATURES

Sr.No. Safety Safety Provision
8.1 Condenser Assly Safety valve provided on the plant steam inlet at
column Assly
Set Point: 6.1 kg/cm2
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
Float type level Controller
Level Control
8.5 Operational safety 1. Emergency OFF
2. Operating Air Pressure Low

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

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

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

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

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 17 of 50

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
After reaching boiler steam pressure 3 Kg/cm2 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

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 18 of 50

Set the Feed water flow rate as per the consumption data
(Refer GA DRG / consumption data sheet on the plant.)
When temp. of distillate reaches more than 60 C start cooling pump.
Set the Cooling water flow rate as per the consumption data
(Refer GA DRG / consumption data sheet on the plant.)
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/cm2
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/Cm2
2. Air Pressure Switch 3 Kg/Cm2
3. Air pressure regulator 4 Kg/Cm2
4. Feed water outlet pressure switch 7 Kg/Cm2
5. Feed water inlet pressure switch 1 Kg/Cm2
6. Cooling water inlet pressure switch 1 Kg/Cm2
7. Overload Relay As per pump selection

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 19 of 50

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 Result
1 Boiler Steam Temperature Low Dumping ON (WFI Rejection)
2 Feed Water inlet pressure low Feed Pump and control valve OFF
3 Feed water pressure low Indication
4 Feed Water Conductivity High Feed Pump and control valve OFF
5 Insufficient Evaporation Feed Pump and control valve OFF
6 Last Column Purging Problem Feed Pump and control valve OFF
7 Cooling water temp. High Indication, Alarm
8 Air Pressure low Feed Pump ,control valve and Dumping ON
(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

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 20 of 50

9.7 PLC DETAILS

Make : Mitsubishi
HMI : E-1061
With Real time tracking
5.7 Colour Touch screen Display

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 COOLING WATER PRESS. S/W
IN10 SPARE
IN11 SPARE
IN12 SPARE
IN13 SPARE

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 21 of 50

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 RELATED ANALOG INPUT FROM RELAY/INSTRUMENT

CHANNEL 1 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

RELAY/INSTRUMENT
CHANNEL 1 BOILER STEAM TEMP.
CHANNEL 2 COOLING WATER TEMP.
CHANNEL 3 W.F.I. TEMPERATURE
CHANNEL 4 SPARE

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review 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

INITIAL HOOTER OFF 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

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 23 of 50

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

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 24 of 50

9.9 SETTABLE PARAMETER RANGE

PARAMETER RANGE
PRE HEATING TIME ( 60 - 600 Sec )
INITIAL HOOTER OFF TIME ( 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 )
PURGING FAULT ON TIME ( 1 499 Min )
PURGING FAULT OFF TIME ( 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.

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 25 of 50

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.

Open the Boiler steam stop valve (GV1) and allow Boiler Steam to enter in to the 1st
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 143o C
4 Kg/Cm 152o C
5 Kg/Cm 159o C
6 Kg/Cm 165o C

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

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
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Design Review 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.

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 27 of 50

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

If steam trap (ST1) provided at the bottom of 1st 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).

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review 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
the 2nd, 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 un-
evaporated 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

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review 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.

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

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..

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review 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

Y 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

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
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Design Review DRD : Page 32 of 50

Y 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

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 33 of 50

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
PURGING FAULT ON TIME 03 Min
PURGING FAULT OFF TIME 05 Min
INITIAL HOOTER OFF TIME 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

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 34 of 50

DATE TIME TEMPERATURE in DegC COND. in us/cm

BOILER COOLING FEED
W.F.I W.F.I
STEAM WATER WATER
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

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review 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.

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review 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.

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review 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.

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 38 of 50

12.0 IDENTIFICATION OF COMPONENTS FOR CERTIFICATION &

CALIBRATION

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 Calibration Certificate
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 Calibration Certificate
Material of Construction (For Column Assly & Pipe
12.13 Test Certificate
Line )
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.

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 Pharmalab
M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 39 of 50

13.0 LIST OF COMPONENTS

Sr. No Component Specifications

13.1 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
13.2 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
13.3 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)
13.4 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)

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 40 of 50

13.5 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
13.6 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
13.7 Variable area Make George Fischer
flow meter (P & Model SK-73
I Tag No. FI1 & Tube - Polyamide
FI2) MOC Float PVDF
Gaskets - EPDM
Range 300-3000 LPH
Qty 02
Location 1 At discharge side of feed pump (FI1)
Location 2 At discharge side of cooling pump (FI2)
13.8 2 Way Make Burkert
Pneumatic valve Model 2 way
(P & I Tag No. MOC of Working
SS 316L
PN4 & PN5) parts
MOC of Body SS 316L
Type Piston Actuated
Size DN 20 / 25 (Butt End connection)

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 41 of 50

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)
13.9 2 Way Make Burkert
Pneumatic valve Model 2 way
(P & I Tag No. MOC of Working
SS 316L
PN1 & PN2) parts
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)
13.10 Globe valve (P Make Shakti / Zoloto
& I Tag No. Model Non IBR
GV1) MOC of Working
SS 410
parts
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
13.11 Diaphragm Make Crane Process (Sounders) or equivalent
Valve (P & I Tag Model DN 40
No. DP1) MOC SS 316L

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 42 of 50

Diaphragm PTFE / EPM

Size DN-40 (Triclover End Connection)
Operation Manual
Qty 01
Location At the WFI outlet line
13.12 Diaphragm Make Crane Process (Sounders) or equivalent
Valve (P & I Tag Model DN 25
No. DP2) MOC SS 316L
Diaphragm PTFE / EPM
Size DN-25 (Triclover End Connection)
Operation Manual
Qty 01
Location At the outlet of feed pump
13.13 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
13.14 Steam Trap (P Make Spirax
& I Tag No. ST1 BPT-21,15NB (Threaded End
Model
& ST2) Connection)
Type Balanced pressure thermostatic trap
Max. working
21 Kg / Cm
pressure
Max working
242 C
temperature
Qty 02
Location 1 At First column air vent line (ST2)
At Boiler Steam Condensate line of first
Location 2
condenser (ST1)
13.15 Safety valve (P Make Spirax
& I Tag No. Model SV-11

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 43 of 50

SV1) Size (Threaded End Connection)

Type Spring loaded
Range 75-125 Psi
Qty 01
Location At inlet of the plant steam line
13.16 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
At plant steam condensate drain
Location 1
through first column (BV2)
At plant steam condensate drain by
Location 2
pass to steam trap (BV3)
Location 3 First column drain (BV1)
13.17 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
13.18 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 DN-40 (Triclover End Connection)
Gasket Silicon
Operation Pneumatic
Qty 01
Location At the outlet WFI line

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
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Design Review DRD : Page 44 of 50

13.19 Pressure Gauge Make Warree

(P & I Tag No. Model 4
PG1) MOC SS 316 (Contact parts) (Threaded End
Connection)
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
13.20 Sanitary Make Warree
Pressure Gauge Model 4
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 At discharge side of feed pump
13.21 Control Panel Model 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
Main power
supply On / Off Sulzer
switch
Transformer BHATT MAGNATIC / NARMADA
ELCB + MCB HAGGER

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
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Design Review DRD : Page 45 of 50

Emergency off
Telemechanic
Push button
Auto/manual
Sulzer
Rotary switch
PLC Mitsubishi
Display E-1061 HMI 5.7 colour touchscreen
venting valve
purging valve
On/Off Switch dumping valve
feed pump
cooling pump
Model: 1055-01-10-20-30
Make: Rose mount
Display :16 Character, Two line
Conductivity
Input : From Conductivity Sensor
Meter
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
SS 316L
CS2) parts)
0 C 105 C (Continuous)
Temp. Range
135 C for One hour
Qty 02
Location 1 At inlet of feed pump (CS1)
Location 2 At the WFI outlet line (CS2)
13.23 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

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 46 of 50

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)
13.24 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).
13.25 Sanitary Make Orion
Pressure switch MOC SS 316L (Triclover End Connection)
(P & I Tag No. Diaphragm Teflon
PS2) Range 1 -15 Bar
Qty 01
At the discharge side of feed pump
Location
(PS2).
13.26 Pressure switch Make Orion
(P & I Tag No. MOC SS 316L
PS5) Diaphragm Teflon
Range 0.2-2.6 Bar
Qty 01
At the suction side of cooling pump
Location
(PS5).
13.27 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
13.28 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

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 47 of 50

Qty 02
Location 1 First column (LS1)
Location 2 Last column (LS2)
13.29 Disposable Vent Make Pall
Filter (P & I Tag Model KA1PFRP1
No. VF1) Filter Length 4.2
Medium PTFE
Removal Rate 0.2 Micron
Qty 01
Location At Cooler Air Vent Line (VF1)
13.30 Printer Make EPSON
Model LX-300, 80 column, Dot Matrix
Qty. 01
Location Besides Panel Board

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 48 of 50

14.0 LIST OF DRAWINGS

Sr. No TITLE OF DRAWING DRAWING NO REVISION NO.

14.1 G. A Drawing AC 006 91 09 002 0
14.2 P & I Diagram AC 006 93 09 002 0

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 Calibration Certificate IQ

Operation and Maintenance Manual

15.5 With Dispatch Papers
(1 Set)

15.6 AS BUILT Drawing IQ

Certificates of Bought-out
15.7 IQ
Components

15.8 Factory Acceptance Test Report With Dispatch Papers

16.0 CERTIFICATION
Warranty Certificate by M/s Pharmalab.

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 49 of 50

17.0 FINAL REPORT

Summary

Conclusion

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M/s ABC PHARMA PVT. 700 Ltr/hr. WFI GENERATION
LTD. Job No.: XXXX-
PLANT **
Revision: 00

Design Review DRD : Page 50 of 50

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

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