Equipment Sterilization Performance Qualification Protocol

SUBJECT Equipment Sterilization Performance Qualification Protocol 

The purpose is to describe the format and contents of the equipment sterilization performance qualification protocol. 

It is the responsibility of validation team members to follow the procedures. The quality assurance (QA) manager is responsible for SOP compliance. 

The purpose is to qualify the sterilization cycle of the A-ml vial filling machine parts, filtration assembly, and hose pipes in steam sterilizer 

The sterile solutions are filled in different sizes of ampoules/vials under aseptic conditions. For this purpose, all operations and conditions should be validated according to the approved protocols to ensure the sterility during the aseptic processing to validate the sterilization cycle for A-ml vial filling machine parts and accessories by three heat penetration studies and a microbial challenge test using B. stererotbermophilus strip. 

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SUBJECT Equipment Sterilization Performance Qualification Protocol... 

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