Featured Article: The Pursuit Of A Good Sterility Test Isolator

By Robert Guardino and Kevin Jones

The pursuit of a good sterility test isolator is an adventure that involves deciding the rationale for its use, selecting the equipment, justifying the capital expense, and installing and validating the unit.

We embarked on a mission to study isolators for sterility testing, though many of the issues also apply to aseptic processing. We navigated a variety of roadblocks to realize the efficiency these isolators provide.

The risks cannot be completely eliminated. Removing the operator/analyst from the environment and ensuring that exposure of product and test material only occurs within a sealed, decontaminated environment greatly enhance the process, however. Aside from the obvious regulatory expectations and interests, other issues, such as analyst comfort and the cost of disposables for clean room operation (e.g., gowning, preparation time, sanitization, and clean room monitoring) make the use of isolators enticing.

Isolators with automated decontamination cycles allow for unattended preparation of the working space and test materials. Once all test items are loaded, the cycle can be initiated and decontamination and aeration accomplished without further human intervention. This is a clear advantage over clean room sanitization and rinsing, which involve the manual decontamination of materials required during sterility testing in a clean room. Isolators with an automatic decontamination cycle allow you to prepare the chambers for use, run the cycle overnight, and commence testing the following morning. This functionality saves both time and money.