Leak Rate Testing for Freeze-Dryers

Resource Overview

Assurance of the vacuum integrity of freeze-dryers used for the manufacture of sterile pharmaceutical products is essential for GMP operations. However, there is currently no generally accepted scientific rationale for establishing acceptance criteria for such testing, and current acceptance criteria are generally based on equipment capability.

In this whitepaper learn more from the Simtra BioPharma Solutions team about leak rate testing for freeze-dryers. The whitepaper details a method developed to measure the exact void volume within the dryer. Using a worst-case bioburden value for the infiltrating air, the maximum allowable leak rate was calculated and subsequently converted to the maximum permissible pressure rise during a leak test.