Lyophilizer Requalification Protocol

The purpose is to describe the format and contents of the lyophilizer requalification 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 requalify the freeze drying unit (model no. ) by  

The sterile solutions are filled in different sizes of vials and lyophilized in freeze dryer under aseptic conditions. For this purpose, all operations and conditions were validated according to the approved protocols. To ensure sterility during aseptic processing, the frequency was established to revalidate all sterilization cycles by one-heat penetration/distribution study and microbial challenge test using B. stearothermophilus strip. 

3 Freeze drying unit revalidation is divided into two parts 

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