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

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  • 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.
  • Accountability
    • Production Head and QA Head.
  • Procedure
  • Pre Start up
  • Check that the cartridge filter is assembled as per SOP on assembly of cartridge filter in housing.
  • Check that the cartridge filters are sterilized as per Sop on sterilization of cartridge filter 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
  • List of Annexure / Format
  • No attachment
  • References (if any)
  • SOP of SOP
  • Format on cleaning and sanitation of aseptic area.
  • Reason for revision
  • Not Applicable.
  • Abbreviations
  • SOP    : Standard Operating Procedure.