Stopper Sterilization Performance Qualification Protocol

SUBJECT Stopper Sterilization Performance Qualification Protocol 

The purpose is to describe the format and contents of the stopper 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. 

To ensure sterility during the aseptic processing, it was decided to validate A-mm stopper sterilization cycle by three heat penetration studies and a B. stearothermophilus strip considering maximum load size. 

Heat penetration is the most critical component of the entire validation process. Heat penetration studies will be performed per plant SOP. Using four shelves of the trolley, distribute the load per following sequence  

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SUBJECT Stopper Sterilization Performance Qualification Protocol... 

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