SOP for cleaning of cartridge filter

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

• Cough Relief tablet

• 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.