ABSTRACT
Sterility test is generally performed in a class A laminar air flow cabinet within a class B, in a class A clean room if available or in an isolator. The validation test is based on the incorporation of selected microorganisms during the sterility test procedure in order to check whether they will grow in a visually comparable way to a positive control. The more important issue is the proper validation of the sterility test membrane within the user’s processes. Companies providing sterility test units, systems, and consumables are aware of this and provide training and qualifying sessions on a regular basis. Most of the sterility tests are currently performed using a closed ready to use and disposable filtration set in laminar air flow cabinets or in isolators. The growth direct system from Rapid Micro Biosystems is designed for Microbial Enumeration, but the extension for the usage of sterility testing is currently in development.
