sop for Sanitization of Ultrafiltration System
To lay down a procedure for the Sanitization of Ultrafiltration System.
This Standard Operating Procedure is applicable for the Sanitization of Ultra Filtration System to be followed at formulation plants
3.1 Engineering Officer / Executive shall be responsible for the execution of this procedure.
3.2 Engineering Manager shall be responsible for the implementation of this SOP.
3.3 Head QA/designee shall be responsible for the compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure etc
KL : Kilo Liter
No : Number
PW : Purified Water
QA : Quality Assurance
ER : Engineering
H2O2 : Hydrogen Peroxide
5.1 Fill the UF water Storage Tank up to 400 Liter with UF product water.
5.2 Add H2O2 in the UF product water tank in such a way that H2O2 concentration should be 10 ppm . ie
for 400 liter of water add 13.33 ml of H2O2 .
5.3 Start the UF feed pump in manual mode.
5.4 Re-circulate UF product water in Ultra Filtration System for 60 minutes.
5.5 Stop the UF feed pump and hold it for 1 hour.
5.6 Drain out the UF water tank by opening bottom valve and close the same when tank becomes empty.
5.7 Fill the water tank with UF water and rinse the UF membrane through the UF product water for
half an hour by starting the UF feed pump in manual mode.
5.8 Stop the UF feed pump and drain out the UF product water by opening the valve and close same when tank becomes empty.
5.9 Fill the tank with UF product water. Start the UF feed pump in manual mode. Re-circulate UF product water in Ultra Filtration System for 15 minutes. And then take sample of water through valve and test the presence of H2O2.
5.10 H2O2 is present in the water then follow the steps 5.7 to 5.9 till H2O2 in the UF water becomes nil H2O2 presence nil.
5.11 After getting H2O2 nil in the UF product water, start the Purified water System in the normal mode.
5.12 Record the data as per Annexure-1.
6.0 Forms and Records
6.1 Sanitization of Ultra Filtration record – Annexure-1
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Engineering Department