- Objective:
- To lay down a procedure on assembly of cartridge filter in housing.
- Scope
- This SOP is applicable for assembly of cartridge filter in housing.
- Responsibility
- Officers or above – Production.
- Accountability
- Production Head.
- Abbreviations
- SOP : Standard Operating Procedure.
- WFI : Water For Injection
- Procedure
- Close the valve of compressed air or Nitrogen Line or purified water or WFI line.
- Depressurize the filter by opening both the vents then tighten the air vents.
- Disconnect the filter from the line and transfer them to wash equipment area.
- Put a blind or spare filter on the line (for aseptic area blind or spare filter should be sterilized).
- Open the triclover clamp and remove the base plate from the body.
- Take out the cartridge filter from its housing.
- Perform the cleaning of cartridge filter as per SOP.
- Keeps the filter vertically in one hand facing “O” ringside of filter downwards.
- Place the cartridge filter on the base plate in such a way that “O” ring covers the base plate acceptor hole.
- Apply pressure with twisting motion from the upper end of filter by hand so that filter “O” ring assembly fit into base plates acceptor hole.
- Place the housing on the filter and check that it should not touch the filter.
- Ensure proper placing of silicon gasket between base plate and housing.
- Tighten the triclover clamp and air vents.
- Connect the housing inlet to one end and housing outlet to other end on the respective line.
- Forms and Records (Annexures)
- Not Applicable
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision
– 00 New SOP
