- 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.
