USER REQUIREMENT SPECIFICATION FOR WATER

TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Name of The Water for Injection Generation System

Equipment / System

Department / Area Production

Quantity Required 01 No.

Page 1 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

S.No. Name of the Content Page No.

Cover Page 1
Table of Contents 2&3
Revision History 4
1.0 PROJECT DESCRIPTION 5
2.0 PROCESS DESCRIPTION 5
2.1 Name of the Equipment / System / Facility 5
2.2 Purpose of the Equipment / System / Facility 5
2.3 Number of Equipments Required 5
2.4 Process Description and Schematic Flow diagram 5
2.5 Chemical / Physical characteristics of the process material 5
2.6 Suggested capacity 5
2.7 Any other specific requirement 5-6
3.0 OPERATIONAL / FUNCTIONAL REQUIREMENTS 6
3.1 Production Stage 6
3.2 Material inputs to the Equipment and Function 6
3.3 Desired outcome from the Equipment 6
3.4 Desirable material loading method into the equipment / System 6
3.5 Desirable material unloading method from the Equipment / System 6
3.6 Expected operational hours per day and output in lots per day 6
3.7 Preferable method of cleaning 6
3.8 Recommended cleaning and / or sanitization agent and its chemical
6-7
nature
3.9 Required Utilities 7
3.10 Process control requirements 7-8
3.11 Desired level of instrumentation and Accuracy levels 8-9
3.12 Language requirement 9
3.13 Data Acquisition 9
3.14 Attachment / connectivity with other equipments 9
3.15 Software details 9
3.16 Operational Range (Minimum & Maximum) 9
3.17 Tolerance Limits 9
3.18 Least Count (if applicable) 9
3.19 Any other specific requirements 9 - 10
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

S.No. Name of the Content Page No.

4.0 GMP REQUIREMENTS 10
4.1 Main component 10
4.2 Specification for Material of Construction 10
4.3 Working area Environmental requirement 10
4.4 Desired means for avoiding contamination & cross contamination of the
10
products
4.5 Power supply – Specify if uninterrupted power supply is required or not 10 - 11
4.6 Power failure and recovery – Specify the action taken in case of power
11
failure.
4.7 Any other specific GMP requirement 11
5.0 SAFETY REQUIREMENTS 11
5.1 Desired Product / Process safety systems 11
5.2 Desired personnel safety systems 11
6.0 DOCUMENTATION REQUIREMENT 11-12
7.0 AUTOMATION 12
8.0 SUPPORT REQUIRED FROM VENDOR 12
8.1 Pre- Installation support 12
8.2 Start-up support 12
8.3 Limitations and Requirement from vendor on post validation changes,
AMC / Service requirement on post installation vendor equipment and 13
training for Operation and Maintenance to staff concerned.
8.4 Any other specific requirements. 13
9.0 VALIDATION REQUIREMENT WITH SCOPE 13
10.0 ABBREVIATIONS 13
11.0 DISCUSSION REVIEW / COMMENTS 13
APPROVAL SIGNATORIES 14

REVISION HISTORY
Page 3 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Revision No. Date Revision Summary

00 –– First Issue

1.0 PROJECT DESCRIPTION

Page 4 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

The AUROBINDO PHARMA LTD Unit-IV facility is located in Pashamylaram, Hyderabad,

India. The functional areas of the facility include GMP Production Areas, Packaging areas,
Warehousing and Storage areas, Analytical, Microbiological, Quality Control (QC), Quality
Assurance (QA) and offices.
The APL facility is used for injectable production, including supporting analytical and QC
activities for filing ANDA. The drug products produced are intended for medicines for human
use and as such are governed by current Good Manufacturing Practices (cGMP). This URS
describes the operational, environmental and cGMP requirements of the Water for Injection
Generation System.
2.0 PROCESS DESCRIPTION
2.1 Name of the Equipment
Water for Injection Generation System.
2.2 Purpose of the Equipment
To generate the WFI as per pharmacopeia’s specifications.
2.3 Number of Equipments Required
One Equipment
2.4 Process Description and Schematic Flow diagram
The flow diagram is as follows.
→ Purified Water generation plant Purified Water storage tank Input to WFI generation →
Passing through columns (shell tube heat exchangers) Evaporation and cooling Condensation →
WFI storage tank.

2.5 Chemical / Physical characteristics of the process material

The system shall design by considering the quality parameters as introduced by USP-
34 as maximum allowable parameters at user point.
pH: 5.0 - 7.0
Conductivity: < 1.3 µS/cm @ 25 oC
TOC: < 500 ppb
Micro Organism : NMT 10 CFU /100 mL
Endotoxin : NMT 0.25 EU/mL
2.6 Suggested capacity
3000 L/Hr
2.7 Any other specific requirement
 All welded points are orbital welded, treated and then mechanically polished and
passivated.
 The valves are high purity diaphragm type and pneumatically actuated
 The pipefitting are tri-clamp type and all piping is fully drainable.
 All the valve system will be GEMU
 All the pneumatic system needs FESTO

Page 5 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

 Min 2 years spares parts to be provided

 Require sanitary construction features such as double tube sheets, sloped piping and low
point drains, minimum dead legs and sanitary connections.
 Required uniform wetting and heat transfer. Elimination of bio growth
 Feed water level control: Need PID control loop senses the actual level and adjusts the
flow rate of feed water up or down to maintain the level at the desired point.
 Feed water pump should stop when; -Peed water conductivity is high, Boiler steam
temperature is low, in case of insufficient evaporation, feed water pressure low.
 All columns should have view glass
 Inner and Outer column shell should be < 0.6 Ra, electro polished. Pipeline should be
orbital welded wherever technically possible.
 Required to control the water droplets, particulate matter and Endotoxin from the
evaporation at desired level.
 Required a provision for non-condensable gas removal arrangement.
3.0 OPERATIONAL / FUNCTIONAL REQUIREMENTS
3.1 Production Stage
Generation of WFI.
3.2 Material inputs to the equipment and function
Purified Water and Plant steam.
3.3 Desired outcome from the equipment
WFI as per above specification mentioned under point 2.5.
3.4 Desirable material loading method into the equipment / System
In feed through SS 316, < 0.8 Ra electro polished pipeline from Purified Water storage tank to
WFI generation unit
3.5 Desirable material unloading method from the equipment / System
The feed water should be sequentially evaporated and condensate from the series of columns or
effects. The delivered Water for Injection should be minimum of 80 oC in continuous loop with
all user points.
3.6 Expected operational hours per day and output in lots per day
24 x 7 x 365 Day (contentious or uninterrupted).
3.7 Preferable method of cleaning
Manual cleaning
3.8 Recommended cleaning and / or sanitization agent and its chemical nature
Supplier should provide information for any specific cleaning procedure /effective cleaning
method / agents.
3.9 Required Utilities:
Page 6 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Utility Name Specification Purpose

Pharma grade, oil
Compressed Air free. Pressure: For pneumatic operations
NLT 6.0 kg / cm2
400-440 V, 50 Hz,
Electric supply Power supply
3 phase
Cooling water 2 kg/cm2 For cooling
Purified water 2 kg/cm2 For Product Input
Plant steam supply 6.0 kg / cm2 For Column Heating
3.10 Process control requirements
PLC based control panel:
 PLC based control panel is with two line Display 7.0" Colour HMI which will be
communicating through the Supervisory Control and Data Acquisition System
(SCADA). Operation of system is through PLC, which is programmed and stored in
CPU of the PLC set.
 The equipment should have control system to stop the feed pump in case of low plant
steam temperature and low feed water level in column.
 The equipment should have pressure control system to regulate the cooling water
 The equipment should have Flow control flow meter for controlling the flow rate of feed
water.
Required online:
 Conductivity meter: To monitor conductivity of WFI. Range should be 0-100 micro
Siemens /centimetre or better.
 Flow meter: To indicate feed water flow. Range should be 0 to 5000 Litre/Hour or better.
 Pressure gauge: To indicate plant steam pressure and air pressure. Range should be 0-14
Kg/cm2 (2 No's) and 0-7 Kg/cm2 (l No's) respectively. Placement is one at plant steam,
one at feed water line and one at cooling water line.
 Temperature control: To monitor and control the temperature of Boiler and Pure steam.
Range should be 0 to 200 0 C. The placement should be; One RTD in Plant steam line,
one RTD in WFI Line, four in each columns.
Required the following indication on control panel:
 MMI
 Emergency push button
 Conductivity analyzer
 DTIC for boiler steam and pure steam output temperature.

Page 7 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

 Switches for manual operation- feed pump, purging valve, venting valve and dumping
valve.
 Indication Lamp for - feed pump on.
 Auto/Manual mode switch.
 Main supply switch
Feed pump and sampling valve should stop automatically with respect to following
controls:
 Boiler steam temperature low WFI pressure high
 Feed pump over load relay
 Insufficient feed water
 Purging Problem
 Feed water conductivity high
 Emergency stop
Purging valve should start automatically with respect to following control:
• Boiler steam temperature low
• Column water level high
Purging valve will operate on water level accumulate in last column
• Last column level high
• Purging ON time parameter
•
Purging Hold time
Required safety interlocking between steam control valve to non-condensable gases regulator
Required indication of any respective fault at the P & I diagram with LED indication.
3.11 Desired level of instrumentation and Accuracy levels
Level transmitter:
•
Level transmitter for opening and closing of inlet valves for storage tank to avoid dry
running of distribution pump.
• Accuracy: +/- 0.5% in full scale, capacitance type.
Conductivity transmitter:
• A conductivity transmitter in the supply line shall monitor the quality of PW.
• Accuracy: +/- 0.2 to 0.5 % in full scale
•
Range 0 to 20 µs/cm
Temperature transmitter:
Page 8 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

• RTD type temperature transmitters shall be installed in the tank and in the return line of
distribution loop for monitoring the temperature continuously while the system is in
normal mode.
• Accuracy: +/- 0.5% in full scale, Duplex type.
Pressure gauge:

• Pressure gauge shall be bourdon type with a diaphragm isolator and shall be required for
monitoring of pressure at pump discharge.
• Accuracy: +/- 0.5% in full scale.
Language requirement (Specify such as English/others).
3.12
English
Data Acquisition
3.13 The vendor should provide the print out facility with memory and with 3 level password
protection.
Attachment / connectivity with other equipments
Required attachment to Purified Water storage tank for input of feed water. Required
3.14
attachment to WFI storage tank and WFI distribution loop. Required attachment to Plant steam
generator and Compressed Air generator
Software details
 HMI: Siemens colour touch screen with a suitable size for easy operation
 PLC：Siemens
 Siemens with 21 CFR part11 compliance GAMP-5. Software backup, auto password
3.15 expiry and password change option, printer required and online web support through
modem for emergency trouble shooting.
 3 to 4 unique levels should be available for the system to perform various operations
such as operator/ supervisor/ manager etc. Each level should have a unique password.
 Required PLC and Software backup
Operational Range
3.16 Minimum Maximum
Supplier should provide operating ranges.
Tolerance Limits
3.17
0.2 to 0.3 of any instrument
Least Count (if applicable)
3.18
Minimum legibility.
3.19 Any other specific requirements (e.g. Maintenance requirement)
 All product contact pipeline should be orbital welded.
 The vendor must be able to provide routine repairs when needed beyond the warranty
period at cost to the customer.
 Required audio / visual alarms for all critical insufficiency.

Page 9 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Bought out components make:

S. No COMPONENT DESCRIPTION MAKE

Diaphragm valves with SS handle with PTFE
I Gemu
diaphragm
2 Conductivity sensor Rose mount/ Emerson
3 Flow meter E+H
4 Pressure gauge Warre / Baumer
5 Compound gauge Warre / Baumer
6 Steam trap Forbs Marshall / Spirax
7 Manual ball valve for jacket condensate Shaktti /approved vendor
8 PLC Allen bradlly / Siemens
9 Temperature sensor Radix
10 Level transmitter Endress + Hauses
11 Pump Ground foss
12 Safety valve Approved vendor

4.0 GMP REQUIREMENTS

Main component
4.1
Main component should comply with valid regulated guidelines for cGMP practice.
Specification for material of construction

4.2 Product contact parts SS 316L, <0.38 Ra electro polished.

Non contact parts SS 304

Working area environmental requirement
4.3
Machine should operate under clean environment / unclassified area.
Desired means for avoiding contamination and cross contamination of the products
4.4 Cleaning station should equip with independent connections to the relevant circuits to avoid
cross contamination.
Power supply – Specify if uninterrupted power supply is required or not
 Required uninterrupted power supply for PLC. UPS port is reserved for PLC.
 Control panels shall have undariations laborites UL-508A certification for industrial
4.5 equipment or equal.
 Controls shall meet the national Electrical Code (NEC), NEPA/NEC70&79 for industrial
machinery as applicable or equal.
 Wiring on the machine in the control cabinets to be terminated at both ends and match
the numbering or tag shown in documents & drawings.

Page 10 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Power Failure and recovery– Specify the requirements in case of power failure.
4.6
Required UPS back up for power supply.
Any other specific GMP requirement
 Require a design to prevent mixing of plant steam and pure steam
 All parts coming to contact with pure steam are electro polished, pipe joints are orbital
4.7
welded and gaskets are made from pure Teflon or pharmaceutical grade silicon
 Steam safety valve shall (Non-sanitary) spring loaded, MOC CS maximum.
 Orbital welding shall be done using 99.993 % pure argon gas.
5.0 SAFETY REQUIREMENTS
Desired Product / Process Safety Systems
 Safety valve provided on the boiler stream inlet at column and pure steam line.
 Feed Pump: Regarding feed pump thermal over loaded relay, feed water pressure sensor
at the inlet of the feed pump and NRV
 Required float type level controller for last column waste water

Emergency off:
5.1  Level sensor: Level sensor in column should control the level of water to prevent the
plant steam from contamination with the feed water.
 Pressure control: At high pressure of pure steam, feed pump should stop
 Out of Specification and system failure audio and visual alarm system
 Feed water pump should start after and if plant steam temperature meets the process set
point. Feed water pump should stopped when air pressure is below the set point, feed
water conductivity is high, Boiler steam temperature is low, in case of in sufficient
evaporation, feed water pressure low.
Desired personnel safety systems
5.2  Emergency stop provision.
 All Electrical Wiring should be concealed
6.0 DOCUMENTATION REQUIREMENT
Desired Document
1. User manuals:
Operation and Maintenance manuals
 Specialized procedures, if applicable (such as Calibration, Cleaning, etc.)
 Specifications and sources of some important materials, if applicable (such as
lubricants, cleaning agents, etc.)
2. Preventive maintenance manual including:
Equipment and Instrument list with component descriptions
Electrical component parts list with descriptions
Spare parts list with appropriate identification nos., if any
Change parts list with appropriate identification nos., if any

Page 11 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

The equipment shall be designed to use standard tools for maintenance and repairing.
Any special tools required for maintenance should be provided along with the
equipment.
3. Drawings:
Engineering drawings (For approval, Approved, As built, As installed)
Electrical circuit diagrams
Piping and Instrument drawings for the product path shall meet the ASME and 3A
specifications requirements as applicable.
System schematics.

4. Factory Acceptance test:

Detailed list of modifications after contract and / or in final approved design, Material
specifications and test certificates, Instrument Calibration certificates, Functional /
Factory acceptance certificates (such as weld inspection, Passivation, pressure /
vacuum holds, etc.)
5. Validation documents:
Detailed list of modifications after contract &/or in final approved design
Material specifications and test certificates
Instrument Calibration certificates
Design Qualification Protocol.
Installation Qualification Protocol
Operational Qualification Protocol
Required PLC validation
Certificates of Materials and gauges with respect to NIST/NPL.
Certificates of All welding joints.
Required PLC and Software backup

AUTOMATION
7.0 Minimum requirements in critical process area to be subjected to automation.
8.0 SUPPORT REQUIRED FROM VENDOR
Pre- Installation support
8.1
Foot prints of Machine, Utilities and Piping requirements.
Start up support
8.2 FAT required before delivery. Supplier should provide a checklist and is responsible for total
completion up to performance qualification including training.
Limitations and Requirement from vendor on post validation changes, AMC / Service
8.3 Requirement on post installation vendor equipment and training for Operation and
Maintenance to staff concerned.

Page 12 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001


Vendor is responsible for performance of the equipment even in post validation
discrepancy.
 Required AMC service.
 Required training on Operation and Maintenance.
Any other specific requirement
8.4 The machine should be such a way that to fit with tunnel sterilizer.
Control cabinet with integrated temperature monitoring to protect the installed components
VALIDATION REQUIREMENT WITH SCOPE
Validation topic Yes/ No Scope
Design Qualification YES Supplier
9.0 FAT & SAT YES Supplier / user
Installation Qualification YES Supplier / user
Operational Qualification YES Supplier / user
Performance Qualification YES Supplier / user
ABBREVIATIONS
AMC : Annual Maintenance Contract
ANDA : Abbreviated New Drug Application
ASME : American Society for mechanical engineering
DQ : Design Qualification
EU : European Union,
FAT : Factory Acceptance Test.
GMP : Good Manufacturing Practices
10.0 ISO : International Organization for standards
IQ : Installation Qualification
LAF : Laminar Air Flow
OQ : Operational Qualification
PQ : Performance Qualification
PLC : Programmable Logic Control
MOC : Material of Construction.
NIST : National Institute of Standards and Technology
NPL : National Physical Laboratory
NEC : National Electrical Code
DISCUSSION / REVIEW / COMMENTS
11.0 The user requirement specification of Water for Injection Generation System reviewed for
releasing the purchase order.
APPROVAL SIGNATORIES

Page 13 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR WATER
TITLE :
FOR INJECTION GENERATION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Name / Designation Signature Date

Prepared By

Reviewed By

Approved By

END OF DOCUMNET

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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307