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SOP on Assembly of cartridge filter in housing.

  • 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

     

 

 

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