- Objective:
- To lay down a procedure for Cleaning of sterilizing tunnel.
- Scope
- This SOP is applicable for Cleaning of sterilizing tunnel for Production dry powder Injection facility.
- Production Officers / Executive.
- Responsibility
- Accountability
- Production Head shall be accountable for the compliance of SOP.
- Abbreviations
- SOP : Standard Operating Procedure.
- WFI : Water for Injection.
- S.S. : Stainless Steel
- IPA : ISO Propyl Alcohol
- Procedure
- Cleaning of the tunnel shall be carried out every day at the end of day’s operation. Also the cleaning is done every weekend when there is no operation.
- Ensure that day production is over.
- Main switch off the control panel of tunnel.
- Allow the tunnel to cool down up to room temperature.
- Ensure that the shutter of the tunnel from the side of vial filling room is closed.
- Open the vertical side panels of the Sterilizing Tunnel.
- Visually inspect the conveyor and inside of the tunnel for presence of any particulate or glass pieces.
- If observed, any particulate and glass pieces clean it by vacuum cleaner.
- Lift the dampers of the Sterilization zone.
- Clean the inside chamber of sterilizing tunnel using vacuum cleaner.
- Remove the horizontal SS plate below the conveyer from base of machine to clean the conveyer from lower side.
- Clean the SS plate by wet mopping using lint free duster soaked in WFI.
- Clean the SS plate by wet mopping using lint free duster soaked in IPA.
- Clean the remote portion of the sterilizing zone by lint free duster (Soaked in WFI) tied at the end of the SS rod.
- Start conveyor rotation (Bypass the control panel for manual control)
- Mop the sterilizing tunnel conveyor from upper and lower sides with lint free duster soaked in WFI followed by dry moping with lint free dry duster.
- Mop the sterilizing tunnel conveyor from upper and lower sides with lint free duster soaked in IPA followed by dry moping with lint free dry duster.
- Stop conveyor rotation.
- Clean the Sterilizing Tunnel outer surface using dry lint free duster.
- Clean the control panel outer surface using dry lint free duster.
- Change the status of equipment status board to write “Cleaned Ready for Use”.
- Record the details of cleaning operation in the operation and cleaning record as per SOP and get it checked by concerned Supervisor / Officer.
- 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
