sop for for Filtration of Bulk Solution
To lay down a procedure for Filtration of Bulk Solution.
This SOP is applicable for Filtration of Bulk Solution in Production Area
Officer / Production Manager
5.1 Clean the Cartridge Filter Housing containing 1.0µ and 0.2µ Cartridge Filters respectively.
5.2 Assemble the Cartridge Filter and housing and check for proper fixing of “O”– Ring to ensure complete tightness of the Filtration assembly.
5.3 Perform Bubble Point Test of Cartridge Filter to ensure its integrity before Sterilization.
5.4 Assembled Cartridge filter housing containing Cartridge Filter of 0.2 µ on product transfer line and perform online SIP.
5.5 Release the nitrogen from filter prior to startup of the filtration operation.
5.6 Start the Batch Filtration after release of the Batch from the QC and as per instructions from Manufacturing Chemist.
5.7 After completion of filtration, carryout CIP then perform the Bubble Point Test of the Cartridge Filter to confirm the Post Filtration Integrity.
5.8 Record the Filtration related details at specified place in respective BMR & Equipment Log as per Format.
SOP : Standard Operating Procedure
SIP : Sterilization in place
CIP :Cleaning in place
WFI : Water for Injection
Ltd. : Limited
QA : Quality Assurance
BMR : Batch Manufacturing Record
Controlled Copy : Production Department
Master Copy : Quality Assurance
9.0 REVISION HISTORY:
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