Stopper Sterilization Requalification Protocol

The purpose is to describe the format and contents of the stopper sterilization requalification 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 revalidate A-mm stopper sterilization cycle once in a year by one heat penetration study and a B. stearotbermophilus strip considering maximum load size. 

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

stearothermophilus strip and 16 thermocouples will be inserted in bags that are placed in different positions in the chamber. The Fq value will be calculated based on the base temperature and recorded by the thermocouples inside the commodity. Thermocouples should be calibrated before performing the heat penetration study and the calibration should be checked again after completion of the study. 

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