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 |
