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.
RESPONSIBILITY:
Technical Assistant –Production shall follow the procedure mentioned in SOP.
Executive – Production shall ensure the compliance as per SOP.
ACCOUNTABILITY:
Production Head
Head Quality Assurance
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.
REFERENCES:
Not Applicable
ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Controlled Copy No. 01 Head Quality Assurance
Controlled Copy No. 02 Head-Production
Master Copy Quality Assurance Department
ABBREVIATIONS:
SOP : Standard Operating Procedure.
WFI : Water for Injection.
S.S. : Stainless Steel
IPA : ISO Propyl Alcohol
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To be written manual |