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

July 16, 2016January 13, 2024 Pharmaceutical Guidanace

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.

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