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SOP on Filtration of disinfectant solution and water for injection through cartridge filter.

  • Objective:
  • To lay down a procedure on filtration of disinfectant solution and water for injection through cartridge filter.
  • Scope
  • This SOP is applicable for filtration of disinfectant solution and water for injection through cartridge filter.
  • Responsibility
  • Officers or above – Production shall be responsible for follow the procedure mentined in this SOP.
  • Accountability
  • Production Head and Head QA shall be accountable for compliance of this SOP.
  • Abbreviations
  • SOP: Standard Operating Procedure.
  • Procedure
  • Pre Start up
  • Check that the cartridge filter is assembled as per SOP on assembly of cartridge filter.
  • Check that the cartridge filters are sterilized as per Sop on sterilization and ensure that they have not exceeded the due date for sterilization.
  • Check that the integrity testing is carried out as per the SOP on operation of integrity test apparatus.
  • Collect the disinfectant solution, Iso propyl alcohol and water for injection in controlled area in the pressure vessel as per the SOP on preparation of disinfectant solution.
  • Start up
  • Connect the pressure vessel outlet to the silicon pipe on the wall between controlled and aseptic area through pipe. Connect the silicon tube to the inlet of cartridge filter housing.
  • Connect the downstream outlet nozzle of cartridge filer to the inlet of sterile collection vessel through sterile tubing in aseptic area.
  • Connect the compressed air line with the stainless steel pressure vessel in the controlled area.
  • Close the extra inlet of collection vessel with silicon tubing.
  • Open the air compressed air line valve slowly and remove the air from the filter housing by opening air vents and again tighten the vents when droplets starts oozing out.
  • Increase the air supply until the liquid starts flowing through the cartridge filtration assembly line.
  • Filter the disinfectant solution, concentrated isopropyl alcohol and fresh water for injection. Flush the cartridge filter with Water for Injection before proceeding for filtration of Different sanitizing agent.
  • Collect the filtered disinfectant solution in the collection vessel. Then close the inlet valve of the pressure vessel.
  • Record the details in the format for cleaning and sanitization of aseptic area.
  • Shut down
  • Close the air supply valve when the filtration is over.
  • Check that inlet and outlet valve of all the collection vessels are closed.
  • Re-check the integrity of cartridge filter after the filtration is over as per the SOP on operation of integrity test apparatus
  • 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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