SOP FOR CLEANING AND STERILIZATION OF FILLING MACHINE ACCESSORIES
1.0 OBJECTIVE
The objective of this SOP is to define the procedure for Cleaning & Sterilization of filling machine accessories.
2.0 SCOPE
This Procedure is applicable for Cleaning & Sterilization of filling machine accessories in unit preparation area of production at Pharmaceutical Manufacturing Unit.
3.0 RESPONSIBILITY
Officer / Executive – Production
4.0 ACCOUNTABILITY
HOD – Production
5.0 PROCEDURE
5.1 Dismantle filling machine accessories aseptically from vial filling machine and keep all dismantled machine parts in pass box installed between sterile corridor and unit preparation area
5.2 Person from unit preparation area will take out dismantled machine parts and wash those parts manually with plain purified water followed by using 0.1% Teepol solution.
5.3 Above step should get repeated for one more time.
5.4 Finally rinse all parts with WFI.
5.5 Intimate QA Department to collect the sample of final rinse water for wash water analysis.
5.6 After getting release slip from QC Department, sterilize the filling machine accessories as per validated load pattern in autoclave.
5.7 Unload the sterilized load at aseptic side and & keep it under LAF.
5.8 Record the cleaning and sterilization details in log book.
5.9 Frequency: During Product Change Over / After 5 Batch of Similar Products in continuation / before processing of a batch to be manufactured in case after 12 hours from the completion of last Processed Product’s batch processing.
6.0 ANNEXURE
NA
7.0 ABBREVIATION
SOP : Standard Operating procedure
QA : Quality assurance
QC : Quality Control
WFI : Water for Injection
LAF: Laminar air flow
HOD: Head of department
8.0 REFERENCES
In-house.
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