AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Operation, Cleaning, Calibration and Maintenance of
Title SOP No. EN025-00
WFI Generation system
Department Engineering & Maintenance Effective Date 15/10/2010
Area Water system Area Review Date 14/10/2012

CHANGE HISTORY DETAILS:

VERSION NO. REASON FOR REVISION EFFECTIVE DATE

00 Not Applicable

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 AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Operation, Cleaning, Calibration and Maintenance of
Title SOP No. EN025-00
WFI Generation system
Department Engineering & Maintenance Effective Date 15/10/2010
Area Water system Area Review Date 14/10/2012

1.0 OBJECTIVE:

1.1 To lay down the procedure for Operation, Cleaning, Calibration and Maintenance of WFI
Generation System.

2.0 SCOPE:

2.1 This procedure is applicable to WFI generation system installed in the Water system area
of Engineering & Maintenance Department of Auronext Pharma Private Limited,
Bhiwadi.

3.0 RESPONSIBILITY:

3.1 Executive/ Technical Assistant shall be responsible for the preparation and compliance of the
procedure.
3.2 Head of Department shall be responsible for implementation of the procedure.

4.0 ACCOUNTABILITY:

4.1 Head of the Department shall be accountable for the SOP.

5.0 DEFINITIONS:

5.1 Nil

6.0 PROCEDURE:

6.1 Equipment Detail

6.1.1 Name : WFI Generation System
6.1.2 Make : Pharmalab
6.1.3 Model : 700 WS
6.1.4 ID : EN/WGS-01
6.2 Equipment Description:
6.2.1 WFI Generation Plant produces Pyrogen free, Water for Injection (WFI).
6.2.2 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.
6.2.3 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.

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 AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Operation, Cleaning, Calibration and Maintenance of
Title SOP No. EN025-00
WFI Generation system
Department Engineering & Maintenance Effective Date 15/10/2010
Area Water system Area Review Date 14/10/2012

6.2.4 It employs high temperature (Sterile state temperature), which assures constant sterile
water. As unit does not have moving parts, it demands very little maintenance
6.3 Prestart up Checklist:
6.3.1 Ensure that the Equipment is properly cleaned.
6.3.2 Ensure that the electrical supply is ON.
6.3.3 Ensure that Compressed air pressure is NLT 6 kg/cm2.
6.3.4 Ensure that the plant steam pressure is available at a pressure of 3 kg/cm2.
6.3.5 Ensure that the Emergency Stop button is in released condition.
6.3.6 Ensure that Feed water (Purified water) is available and that the conductivity is below
the required limit.
6.3.7 Ensure the cooling water supply is available.
6.4 Operation:
6.4.1 Open the Plant Steam Globe valve and adjust the pressure to be around 3 kg/cm2.
6.4.2 Turn the main power knob at the back of control panel to ON position and then turn all
the MCB in the control panel to ON position.
6.4.3 Switch on all the MCB in the control panel.
6.4.4 Switch on the printer supply power to start the online printing of the process.
6.4.5 Main Screen will be displayed on the HMI with following Display:

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 AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Operation, Cleaning, Calibration and Maintenance of
Title SOP No. EN025-00
WFI Generation system
Department Engineering & Maintenance Effective Date 15/10/2010
Area Water system Area Review Date 14/10/2012

6.4.6 Main Screen have following functional key:

6.4.6.1 VIEW: This key is used to view the status of Analogue or Digital
input/output signal and also to view the trend data of parameters and to
view Alarms history.
6.4.6.2 SET PARA: This key is used to view and check the set parameter of the
process.
6.4.6.3 P&I: This key is used to view the P & I screen.
6.4.6.4 MFG PARA: This key is used to check the MFG Parameter.
6.4.6.5 START: This key is used to Start the WFI generation system.
6.4.6.6 MAINTENANCE: This key is used during the maintenance mode of the
equipment.
6.4.6.7 ACK: This key is used to acknowledge the alarms.
6.4.6.8 LOG IN: This key is used to login to the specified operating level.
6.4.6.9 LOG OUT: This key is used to logout from the existing operating level.
6.4.7 Press “LOGIN” icon on screen and enter the level one password.
6.4.8 The “PLANT READY TO START’ message will appear on the main screen and on the
printout.
6.4.9 Ensure that all the set parameters of the Process are OK.
6.4.10 Press “START” icon on the main screen to start the Equipment.
6.4.11 Press “START” icon will change to “RUNNING” and the equipment shall start
automatically.
6.4.12 Close the first column condensate drain valve and open column condensate drain
bypass valve and column drain valve.
6.4.13 Open all the WFI sampling valves in order to remove the stale WFI.
6.4.14 Wait for some time till the steam is coming out of the drain bypass valve.
6.4.15 Open the column condensate drain valve and close the column condensate drain valve
and column drain valve.
6.4.16 Close all the sampling points.
6.4.17 Wait till the Feed pump Starts.
6.4.18 Initially set the feed water flow rate to 1/3 rd of the requirement, using the Feed water
Flowmeter.
6.4.19 Wait till the Equipment starts generating WFI.
6.4.20 After some time set the feed water flow rate as per consumption data.
6.4.21 Set the Cooling water flow rate as per consumption data.
6.4.22 The running process details will continue printing on the paper. Once all the parameters
are met, “PROCESS OK” message will be displayed and printed on the printout.
6.4.23 The WFI will be generated from the equipment will start filling the WFI storage tank.
6.4.24 To observe the running process details, press “P & I” icon on the main screen. The
following two windows will appear on the screen with “PROCESS OK” message at
the top.
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 AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Operation, Cleaning, Calibration and Maintenance of
Title SOP No. EN025-00
WFI Generation system
Department Engineering & Maintenance Effective Date 15/10/2010
Area Water system Area Review Date 14/10/2012

Screen -1

Screen -2

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 AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Operation, Cleaning, Calibration and Maintenance of
Title SOP No. EN025-00
WFI Generation system
Department Engineering & Maintenance Effective Date 15/10/2010
Area Water system Area Review Date 14/10/2012

6.4.25 After the requirement of WFI is complete, stop the Equipment as per the following
procedure:
6.4.25.1 Close the plant steam Globe valve and wait till the feed pump gets OFF
with an Alarm Indication.
6.4.25.2 Wait for some time so that the water collected in the column is drained.
6.4.25.3 Stop the equipment by pressing the “RUNNING” icon on the Main
screen.
6.4.25.4 Open the first column condensate bypass valve to drain the condensate.
6.4.25.5 Open all the WFI sampling valves to drain out the water remained in the
plant after the plant has stopped.
6.4.25.6 After some time, close all valves.
6.4.25.7 Switch OFF all the MCB’s in the control panel and turn the Main power
knob to OFF position.
6.4.26 Tear off the printing paper and check for any discrepancy. Put the signature and date on
the printout and store the record.
6.4.27 Record the Equipment usage time and the running process details in Format no.
EN025-F01-00 - Usage record of WFI Generation System. The running process
details should be recorded in every 2 hrs.
6.5 Cleaning:
6.5.1 Clean the equipment from the outside with a lint free cloth soaked in 70% I.P.A. daily
or as when required.
6.6 Calibration:
6.6.1 Validation shall be governed by validation protocol.
6.6.2 All pressure gauges and other measuring devices shall calibrated as per SOP no.
EN023.
6.7 Maintenance:
6.7.1 Do not operate the equipment at low plant steam pressure.
6.7.2 Clean all the Steam traps regularly.
6.7.3 Check the printer for proper prints. Replace the cartridge if necessary.
6.7.4 Always operate the equipment at an optimum Feed water flow rate in order to prevent
Evaporation problem.
6.7.5 Do not operate the equipment if the feed water conductivity is not below limit.
6.7.6 Regularly refill the Filter Air regulator with lubricating oil.
6.7.7 In case of any discrepancy affix “Under Maintenance” tag with sign & date and inform
the service engineer if required.

7.0 ABBREVIATION:

7.1 MCB: Miniature circuit breaker

7.2 P&I: Piping and Instrumentation

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 AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Operation, Cleaning, Calibration and Maintenance of
Title SOP No. EN025-00
WFI Generation system
Department Engineering & Maintenance Effective Date 15/10/2010
Area Water system Area Review Date 14/10/2012

7.3 HMI: Human machine Interface

7.4 NLT: Not less Than
7.5 IPA: Iso propyl alcohol

8.0 REFERENCES:

8.1 Operation and maintenance manual of Equipment

9.0 DISTRIBUTION LIST:

9.1 Control copy of SOP shall be distributed to Quality Assurance Department and
Engineering & maintenance.

10.0 ANNEXURES:

10.1 Usage Record of WFI Generation System : Format No. EN025-F01-00

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 AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Title Operation, Cleaning, Calibration and Maintenance of WFI Generation System SOP No. EN025-00
Department Engineering & Maintenance Effective Date 15/10/2010
Area Water system Area Review Date 14/10/2012

Annexure – 01
AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

ENGINEERING & MAINTENANCE DEPARTMENT

USAGE RECORD OF WFI GENERATION SYSTEM

Equipment ID:
Equipment Operated Checked
Running Process Details Remarks
Stop Time by by
Equipment
Date Plant steam Plant Steam Cooling Water WFI Feed Water WFI
Start Time Observation
Pressure Temperature Temperature Temperature Conductivity Conductivity
Time
(in kg/cm2) (in °C) (in °C) (in °C) (in µS/cm) (in µS/cm)

Format No.: EN025-F01-00

END OF DOCUMENT

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