SOP on cleaning of Liquid filling machine (Watson Marlon )

December 19, 2019January 28, 2023 Pharma Editor

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

MASTER FORMULA OF PHENYLEPHERINE HYDROCHLORIDE,CETRAZINE DIHYDROCHLORIDE ,ARACETAMOL & CAFFEINE ANHYDROUS TABLETS

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

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