SOP on cleaning of Liquid filling machine (Watson Marlon )
- Objective:
- To lay down the procedure for cleaning of liquid filling machine (Watson Marlon).
- Scope
- This SOP is applicable for the procedure of cleaning of liquid filling machine shall be accountable for the compliance of SOP.
- Responsibility
- Production Officers / Executive.
- Accountability
- Production Head shall be accountable for the compliance of SOP.
- Abbreviations
- SOP : Standard Operating Procedure.
- WFI : Water for Injection
- Procedure :
- Stop the liquid dosing from the touch screen of the liquid filling machine after the filling activities are over Transfer the goggles to the controlled area for cleaning and sanitization.
- Put the filling machine on emergency mode.
- Remove the power cord of the liquid filling machine from the back panel of vial filling and bunging machine .
- Open the guard of the vial filling & bunging machine.
- Dismantle the removable parts of the liquid filling machine like silicon tubes silicon tube holders, communicator chord etc.
- While removing silicon tubes keep the face of the filling nozzle upwards so that there is no spillage of the solution transfer the extra solution from the tubes into a glass is no spillage of the solution transfer the extra solution from the tubes into a glass
- Inspect the filling machine base for any spillage of the liquid solution in case found immediately removes with disinfectant solution.
- Transfer the change parts like silicon tubes to the cooling zone through pass box no and to controlled area through pass box no .
- Rinse the change parts with WFI (2-3 times) under equipment cleaning LAF in controlled area. Send the rinse water sample to QC Dept. for trace water analysis by LBPC and Endotoxin test.
- After receiving the report sterilize these change parts with machine parts load.
- Clean the machine assembly with WFI soaked in a sterile lint free duster.
- Disinfect the machine assembly with disinfectant solution (verosil pharma 20 %).
- Dry the machine assembly by wiping with sterile lint free duster.
- Record the details of operation, cleaning and preventive maintenance of the machine in equipment log book as per SOP and the BMR .Get the details checked by the Production officer/supervisor
- 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
