Depyrogenation Tunnel Performance Requalification Summary Report

Depyrogenation Tunnel Performance Requalification Summary Report [Pg.645]

The purpose is to describe the contents of the depyrogenation tunnel performance requalification summary report. [Pg.646]

It is the responsibility of validation team members to follow the procedures. The quality assurance (QA) manager is responsible for SOP compliance. [Pg.646]

The purpose is to requalify the sterilization and depyrogenation cycle of the A-ml tubular clear glass vials in hot sterilization tunnel (model AAAA, serial no. BBBB) by one heat penetration study and endotoxin challenge test. [Pg.646]

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