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Standard Operating Procedure (SOP) for Operation and Maintenance of Purified Water Loop system used in pharmaceutical drug manufacturing plant.

Purified Water Loop System

1.0   PURPOSE:

• • The purpose of this SOP is to define the procedure for operation and maintenance of Purified water loop system.

2.0   SCOPE:

• • This procedure is applicable for Purified water loop installed at pharmaceutical drug manufacturing plant.

3.0   REFERENCES:

• • SOP for Passivation & Sanitization Procedure

• • In House Procedure.

4.0   RESPONSIBILITY – PURIFIED WATER LOOP SYSTEM:

• • Technician shall be responsible for operation of the Purified water loop system as per the requirement.

• • Maintenance Supervisor shall be responsible to check the operation and maintenance of Purified water
  • loop system.

• • Maintenance Supervisor shall be responsible for periodically maintaining the record as per Annexures.

• • Department Head shall be responsible to ensure performance of system and monitoring of system parameters.

• • QC Officer shall be responsible to test water samples and maintain records.

• • QA Head and Quality Head shall be responsible to review and approve the SOP.

5.0   ABBREVIATIONS USED IN SOP FOR PURIFIED WATER LOOP:

• • ID : Identification

• • NA : Not Applicable

• • PWST : Purified Water Storage Tank

• • SS : Stainless Steel

• • STV : Steam Valve

• • Temp: Temperature

• • V : Valve

6.0   PROCEDURE – HANDLING OF PURIFIED WATER LOOP SYSTEM:

• • Operation of loop:

  • Operate pump 1 and pump 2 alternatively before at the time of Sanitization.

• • Ensure that valve V1 is open for both pumps.

• • Press START push button of Circulation pump.

• • For Pump 1 Operation: – Open valve V2 & V3 and supply pressure is maintained at not less than 1.2 kg/cm².

• • For Pump 2 Operation: – Open valve V4 & V5 and supply pressure is maintained at not less than 1.2 kg/cm².

• • The velocity of return line should be maintained at not less than 0.9 m/sec and maintain the record at four times in a day as per Annexure-6.

• • Purified water has to circulate continuously for 24 hours a day.

• • Maintain water level in the tank through fresh purified water supply from De-mineralized water plant.

• • Press Stop Push button to stop the circulation pump.

• • Close respective suction and discharge valves of pump.

• • Whenever circulation is stopped or loop is opened for maintenance, the loop system has to be heat sanitized.

• • Maintain loop operation record at four times in a day as per Annexure-1.

• • Maintain the purified water storage tank temperature at 12 hours interval as per Annexure-2.

• • Heat Sanitization of Loop (Refer Guideline for Passivation and Sanitization Procedure).

• • Procedure for replacement and Integrity testing of Vent Filter :

• • Frequency of filter replacement: Every 3 months ± 15 days or physical damage observed in filter, whichever comes earlier.

• • One month before the expiry of filter life cycle, we should send the new filter for integrity testing to third party/ in house.

• • At the time of installation/ replacement the new filter make sure that filter received with vendor certificate and has passed integrity test done by third part/ in house.

• • Remove old filter with housing from tank.

• • Replace new test filter with housing on the tank.

• • Update filter replacement status label as per Annexure-4.

• • Pack the used filter in a PP bag and send it to outside agency for integrity testing.

• • The outside agency will return the tested filter with certificate in the packed condition.

• • In case of failure in integrity test of used filter, inform to QA department and investigation to be carried out for impact assessment on released batches, throughout life cycle of filter usages.

• • Maintain Vent filter replacement Record as per Annexure-3.

• • Water Leakage Monitoring:

• • Leakage of water at generation point should be checked and attended on daily basis and maintain the record as per Annexure -5.

• • Leakage of water at distribution lines should be checked at least once in a month and maintain the record as per Annexure -5.

7.0   ANNEXURES – PURIFIED WATER LOOP SYSTEM:

Annexure 1: Purified Water Loop Operation Record.

Annexure 2: Purified Water Storage Tank Temperature Record.

Annexure 3: Purified Water Tank Vent Filter Record.

Annexure 4: Vent Filter Replacement Status Label.

Annexure 5: Water Leakage Monitoring Record.

Annexure 6: Return Line Velocity Record.

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