AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Operation, Cleaning, Calibration and Maintenance of
Title SOP No. EN026-00
Pure Steam Generator
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. EN026-00
Pure Steam Generator
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 Pure
Steam Generator.

2.0 SCOPE:

2.1 This procedure is applicable to Pure Steam generator 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 : Pure Steam Generator
6.1.2 Make : Pharmalab
6.1.3 Model : 750 PSG
6.1.4 ID : EN/PSG-01
6.2 Equipment Description:
6.2.1 Pharmalab Pure Steam Generation System produces Pyrogen free, sterile, Pure
Steam.
6.2.2 It operates on the Distillation as a Unit Process. Sterile steam generation engross
with Liquid to Vapor phase change to produce very high purity steam. It removes
the impurities at sterile temperature without using any filtration medium.
6.2.3 PSG works on “Falling Film Evaporator” principle. It is most reliable method to
produce pure steam. It employs high temperature (Sterile state temperature),

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 AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Operation, Cleaning, Calibration and Maintenance of
Title SOP No. EN026-00
Pure Steam Generator
Department Engineering & Maintenance Effective Date 15/10/2010
Area Water system Area Review Date 14/10/2012

which assures constant production with high quality. As unit does not have
moving parts, it demands very little maintenance.
6.2.4 Pure Steam is used for steam sterilization in Autoclave, pipelines, tanks, fermenters,
and humidification of sterile area
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 6 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.
6.4 Operation:
6.4.1 Open the Plant Steam Globe valve and adjust the pressure to be around 6 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. EN026-00
Pure Steam Generator
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 MODE: This key is used to start the NCGR tank and the Plant.
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 “NCGR START’ message will appear on the main screen and the print.
6.4.9 Press “MODE” icon on the main screen. Following Screen will appear on HMI.

6.4.10 Press NCGR - “START” icon to start the heating of Feed water inside the NCGR
tank.

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 AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Operation, Cleaning, Calibration and Maintenance of
Title SOP No. EN026-00
Pure Steam Generator
Department Engineering & Maintenance Effective Date 15/10/2010
Area Water system Area Review Date 14/10/2012

6.4.11 The icon will change to NCGR - “RUNNING” and the temperature of the feed water
inside the NCGR tank will start rising till the NCGR tank set temperature is reached.
6.4.12 Once the NCGR tank set temperature is reached, “PLANT READY TO START”
message will appear on the screen and on the printout.
6.4.13 Go the “MODE” menu from the main screen and press MACHINE - “START” icon
to start the machine.
6.4.14 The icon will change to MACHINE - “RUNNING” and the equipment will start
automatically. Adjust the flow rate of the Feed water to the plant as per requirement,
using the Flowmeter.
6.4.15 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.
6.4.16 The Pure Steam will start generating from the equipment and distributed as per
distribution system.
6.4.17 To observe the running process details, come back to MAIN screen and press “P & I”
icon on the main screen. The Following two windows will appear on the screen with
PROCESS OK message at the Top.
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. EN026-00
Pure Steam Generator
Department Engineering & Maintenance Effective Date 15/10/2010
Area Water system Area Review Date 14/10/2012

6.4.18 After the requirement of Pure Steam is over, stop the Equipment as per the following
procedure:
6.4.18.1 Close the plant steam Globe valve and wait till the feed pump gets OFF
with an Alarm Indication.
6.4.18.2 Wait for some time so that the water collected in the column is drained.
6.4.18.3 Go the MODE menu from the Main screen and pressing the MACHINE
“RUNNING” icon and NCGR “RUNNING” ICON to stop the plant and
NCGR tank.
6.4.18.4 Open the boiler steam through Steam trap drain valve and the close the
boiler steam drain valve.
6.4.18.5 After some time, close all manual operated valves.
6.4.18.6 Switch OFF all the MCB’s in the control panel and turn the Main power
knob to OFF position.
6.4.19 Tear off the printing paper and check for any discrepancy. Put the signature and date
on the printout and store the record.
6.4.20 Record the Equipment usage time and running process details in the Format no.
EN026-F01-00 – “Usage Record of PSG”. The running process details should be
recorded in every 2 hrs.
6.5 Cleaning:
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 AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Operation, Cleaning, Calibration and Maintenance of
Title SOP No. EN026-00
Pure Steam Generator
Department Engineering & Maintenance Effective Date 15/10/2010
Area Water system Area Review Date 14/10/2012

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 Frequency: after 6 months±10 days or in case of any major break down.
6.6.3 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
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 PSG : Format No. EN026-F01-00

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 AURONEXT PHARMA PRIVATE LIMITED, BHIWADI

STANDARD OPERATING PROCEDURE

Title Operation, Cleaning, Calibration and Maintenance of Pure Steam Generator SOP No. EN026-00
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 PSG

Equipment ID:
Running Process Details
Equipment Plant steam Plant Steam Pure Steam Pure Steam NCGR tank Feed Water Pure Steam Equipment Operated Checked Remarks
Date
Start Time Observation Pressure Temperature Pressure Temperature Temperature Conductivity Conductivity Stop Time by by
Time 2 2
(in kg/cm ) (in °C) (in kg/cm ) (in °C) (in °C) (in µS/cm) (in µS/cm)

Format No.: EN026-F01-00

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Format No.: QA001-F01-01