SOP for Sanitization of Purified Water Generation System Using Hot Water : Pharmaceutical Guidelines

SOP for Sanitization of Purified Water Generation System Using Hot Water

Standard operating procedure to sanitize the purified water system with the circulation of hot water in tanks and pipelines.

1.0 OBJECTIVE:

      To lay down procedure for sanitization of purified water generation system using hot water.

2.0 SCOPE:

      This SOP shall be applicable for purified water generation system comprising of Micron Cartridge Filter (MCF), Ultra Filtration (UF) system in utility block.

3.0 RESPONSIBILITY:

      Operator/Engineer/Executive

4.0 ACCOUNTABILITY:

      Head of Engineering

5.0 PROCEDURE: 

5.1 Hot water sanitization for MCF and UF system to be carried out by using hot water sanitization skid in the following manner.
5.2 Collect 100 liters of purified water in hot water sanitization skid tank.
5.3 Stop the purified water generation plant (UF).
5.4 Connect flexible stainless steel hose pipes from hot water sanitization skid to MCF inlet and UF recirculation outlet back to hot water skid tank.
5.5 Start the skid pump to circulate water.
5.6 Turn the water heater ‘ON’.
5.7 Adjust the skid pump discharge valve to maintain the system pressure 50-60 psi.
5.8 Initially circulate water at ambient temperature. Gradually increase the water temperature during circulation to 80ºC ±2º C.
5.9 After the temperature reaches 80ºC ±2ºC, continue recirculation for minimum 1 hour.
5.10 During hot water recirculation keep all sampling valves, drain valves and all sensors inlet valves slightly open for 10 minutes.
5.11 Re-circulate the hot water from MCF outlet to recirculation outlet back to hot water skid tank for 15-20 minutes.
5.12 After sanitization is completed, turn ‘off’ the water heater and skid pump.
5.13 Drain about ½ the volume of water from tank.
5.14 Restart the skid pump.
5.15 Gradually add purified water to the skid tank, while recirculating water through the system till the temperature of re circulating water reaches appox. 40ºC.
5.16 Disconnect the hot water sanitization skid from MCF inlet and UF recirculation outlet.
5.17 Start the purified water generation plant (UF).
5.18 Document the sanitization activity
5.19 Frequency once in week.

Related: Sanitization of RO Membranes in Purified Water System

6.0 ABBREVIATIONS:

6.1 SOP : Standard Operating Procedure
6.2 MCF : Micron Cartridge Filter
6.3 UF : Ultra Filtration

Also see: Removal of Pathogenic Bacteria from Water System




Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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