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SOP for cleaning of cartridge filter.

  • Objective:
  • To lay down a procedure for cleaning of cartridge filter.
  • Scope
  • This SOP is applicable for cleaning of cartridge filter.
  • Responsibility
  • Production Officers / Executive.
  • Accountability
  • Production Head shall be accountable for the compliance of SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure.
  • WFI : Water for Injection
  • IPA :  Isopropyl alcohol
  • LAF : Laminar Air Flow
  • Procedure
  • Close the valves and remove the filter housing from the line.
  • Put a blind at the opening using tri-clover clamp.
  • Transfer the filters to Wash Equipment Area and carry out the cleaning operation under the LAF unit.
  • Take out the filters from housing and clean surface of housing with lint free duster.
  • Clean the filters and housing by washing thoroughly with water for injection or Iso Propyl Alcohol (IPA) respectively for Hydrophilic and Hydrophobic filters.
  • Dip the filters in 10 liters of water for Injection or Iso Propyl Alcohol in Stainless Steel vessel respectively for Hydrophilic and Hydrophobic filters for around 5 minutes with gentle shaking in between.
  • Take out the filters after 5 minutes and gently shake to remove excess Water for Injection or Iso Propyl Alcohol from the filters.
  • Dry the filters using compressed air at a pressure not exceeding 0.5 Kg/cm2.
  • Assemble the filters in their respective housings and fix back to their respective lines.
  • Write the date of cleaning and due date for cleaning on the Filter Status Tag.
  • Enter cleaning details in the Filter Cleaning Record Annexure-1
  • Frequency: Filter Cleaning require after 15 days and Filter Replacement require 6 month or whenever filter integrity is fails.
  • List of Cartridge Filter
  • Washing and sterilization Room
  • Hydrophilic Filter
  •  Vial Washing Purified water line (Pore Size – 5.0m)
  • Vial Washing Water for Injection line (Pore Size – 1.0m)
  • Hydrophobic Filter
  • Vial Washing Compressed air line (Pore Size – 0.22 m)
  • Garment washing Room
  • Hydrophilic Filter
  • Garment washing Purified water line (Pore Size – 1.0m)
  • Garment Washing water for Injection (Pore Size – 1.0m)
  • Hydrophobic Filter
  • Garment Washing Compressed air line (Pore Size – 0.22m)
  • Wash Equipment Area
  • Hydrophilic Filter
  • Purified water line (Pore Size – 1.0m)
  • Water for Injection (Pore Size – 1.0m)
  • Hydrophobic Filter
  • Compressed air line (Pore Size – 0.22m)
  • Bung Processor cum Autoclave
  • Hydrophilic Filter
  • Purified water line (Pore Size – 1.0m)
  • Water for Injection (Pore Size – 1.0m)
  • Hydrophobic Filter
  • Compressed air line (Pore Size – 0.22m)
  • Cooling Zone
  •  Hydrophobic Filter
  • Compressed air line (Pore Size – 0.22m)
  • Vacuum Break filter of autoclave (Pore Size – 0.22m)
  • Vial Filling Room
  • Hydrophobic Filter
  • Compressed air line (Pore Size – 0.22m)
  • Nitrogen Line (Pore Size – 0.22m)
  • Vacuum Line (Pore Size – 0.22m)
  • Forms and Records:
  • Cleaning of Cartridge Filter Record – Annexure – 1
  • Filter Replacement Record – Annexure – 2
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number
    Reason for Revision
    00 New SOP

Annexure-1

          Cleaning of Cartridge Filter Record

Cleaning Of Cartridge Filters Record

Filter Location:                                                                                Filter ID No.:

Filter Type:                                                                                       Pore Size:

Date Cleaned By Checked By Next Due date Remarks
         

Annexure – 2

Filter Replacement Record

Description of filter:                                    Filter Location:

Filter ID No.                                                Pore size     

S.No Date Previous Filter New Filter Checked By Remarks
Lot. No. Part No. Lot. No. Part No.
               

 

 

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