SIP Cycle for Holding Vessel Requalification Protocol

SUBJECT SIP Cycle for Holding Vessel Requalification Protocol 

The purpose is to describe the format and contents of the SIP cycle for holding vessel requalihcation protocol. 

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

The sterile solutions are filled in different sizes of ampoules/vials under aseptic conditions. For this purpose, all operations and conditions require validation according to the approved protocols and subsequent requalification on an annual basis by one heat penetration study and microbial challenge test using a B. stearothermophilus strip. 

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