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SOP for Sanitization of the Storage tank and Distribution Loopline

1.0 Objective: To lay down the procedure for Sanitization of the Storage tank and Distribution Loopline and cleaning of DM and RO water storage tank.
2.0 Scope: This procedure is applicable for the Sanitization of the Storage tank and Distribution Loopline and cleaning of DM and RO water storage tank in liquid oral department.
3.0 Responsibility: 3.1 Production Chemist, Maintenance Supervisor.
3.2 Head production for overall compliance with this procedure.

4.0 Procedure for Sanitization of Purified water system:

SOP file; with title 'Sanitization of the Storage tank and Distribution Loopline'

4.1 Carry out the sanitization of the storage tank and distribution pipelines in the morning of each working day in the following manner.
4.2 Check that there is sufficient D. M. water in the storage tank up to at least half it’s capacity (about 300 liters) and that the external circulation pump is on.
4.3 Open the steam valve to the heat exchanger in the loop line.
4.4 Introduce steam into the heat exchanger. Note this time Drain out the steam condensate by opening the steam condensate valve.
4.5 The temperature of the water will rise as indicated by the digital temperature recorder connected to the return point of the loop line into the storage tank.
4.6 Note the time when the temperature reaches 80°C (A). The sanitization process commences from this time (B). Continue the steam supply to maintain the temperature above 80°C for at least 1 hour. After 1 hour, close the steam valve to the exchanger and drain off all the water in the storage tank and loop line. Put off the recirculation pump. Note this time when the steam is put off (C).
4.7 This completes the sanitization process. The sanitization time (D) is the time interval between the closing of the steam supply (C) and the time when the water temperature reached 80°C (B). D = B-C. This should be at least of 1-hour duration at a temperature above 80°C.
4.8 Next start the plant and collect about 100 liters of D.M. water in the tank.
4.9 Start the recirculation pump and run for about 5 minutes.
4.10 Put “OFF” the pump and drain the water from the tank and loop line.
4.11 Check the tank for cleanliness.
4.12 The tank is now ready for a collection of fresh D.M. water.
4.13 Use this fresh D.M. water for the day’s production.
4.14 Next start the plant and collect about 100 liters of D.M. water in the tank.
4.15 Start the recirculation pump and run for about 5 minutes.
4.16 Put “OFF” the pump and drain the water from the tank and loop line.
4.17 Check the tank for cleanliness.
4.18 The tank is now ready for a collection of fresh D.M. water.
4.19 Use this fresh D.M. water for the day’s production.

4.20 Cleaning of D.M. Water Storage Tank & RO Water Storage Tank:
4.20.1 Once a week, clean the storage tank and RO storage tank in the following manner.
4.20.2 Start the D.M. plant and collect about 50 liters of water in the DM water storage tank & also the RO water storage tank. Drain the water. Clean the inside of the Tanks with warm water and scrub them with a nylon brush.
4.20.3 Drain the water and clean thoroughly with further three quantities of D.M. water. The tanks are now ready for a collection of fresh water.
4.20.4 Maintain a record of the cleaning process.

4.21 Frequency for Storage tank and Distribution Loopline: Once a week.

5.0 Abbreviations:
D.M.: Demineralised.
R.O.: Reverse Osmosis.

    by
  • Naresh Bhakar
    (Author)

    Naresh Bhakar is the Founder and Author at Pharmaguddu.com, bringing his extensive expertise in the field of pharmaceuticals to readers worldwide. He has exprience in Pharma manufactring and worked with top Pharmaceuticals. He has rich knowledge and provides valuable insights and data through his articles and content on Pharmaguddu.com. For further inquiries or collaborations, please don't hesitate to reach out via email at [email protected].

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