- 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.
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube