Hot Water Sanitization Procedure of Purified Water Distribution Loop

October 23, 2016January 13, 2024 Pharmaceutical Guidanace

Hot Water Sanitization Procedure of Purified Water Distribution Loop
Objective : To ensure that the Purified Water Distribution Loop along with the tank is sanitized at 85 degree Centigrade to reduce the microbial count.
Scope :
Procedure :
Fill the Purified Water Storage Tank till the Half Level.
Ensure Suction & Discharge valve of pump are open and all user points & sampling valves are closed.
Sanitization is required during the Start up of the system, once it is chemically cleaned.
Open Steam Valve and Start elevating the temperature.
When the temperature in the return line reaches 85 degree Centigrade, close the Steam Valve.
Recirculate the Hot Water for 60 minutes.
If the temperature decreases to 80 degree Centigrade, Open the Steam Valve.
Drain the Hot Water from all equipments, user points & sampling points.
Take fresh RO Water and start the system and keep it under recirculation at 85 degree Centigrade.
Handover the System to Validation department for taking samples.
Observation should be filled in Sanitization Record Sheet.

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