Case Study

Validation Strategy For A Sterility Testing Isolator Project

By James R. Rickloff, Partner/Scientific Director Advanced Barrier Concepts, Inc.

This document provides an overview on how to properly validate sterility test isolator systems and then, via a case study, describes a strategy for streamlining the validation process when equivalent isolators and/or generators are installed in a sterility test suite.

The goal is to first qualify the room and equipment contained within it for mechanical and electrical operation, including HVAC characteristics. Following equipment qualification, the decontamination process for bioburden reduction of test materials (including the exterior of sample containers) need to be qualified to provide evidence that sufficient kill is achieved in order to provide a germ-free environment for sterility testing. Additionally, aeration times and conditions are established, verifying the removal of the residual sterilant upon completion of the decontamination process. The final phase of testing involves verification that the decontamination process does not interfere with the results of the sterility test on the target product sample. This is achieved by subjecting the testing materials (including the sample containers and sterility testing supplies) to the sterilant (back-to-back decontamination cycles), then demonstrating that low levels of microbial contamination can still be detected with the sterility test.

This procedure is termed ‘false-negative’ testing and it is a form of a process simulation that provides evidence that the decontamination process does not interfere with the sterility test or environmental monitoring results.