White Paper: Minimizing The Risk Of Secondary Contaminations Through The Use Of Isolators For Sterility Testing

Today, isolators are nearly mandatory in every up-to-date sterility test laboratory. The risk of secondary contamination caused by the analyst or through the environment can be minimized by using isolators to perform sterility testing. The operator has to bear in mind that by using isolator technology no absolute safety regarding secondary contamination is guaranteed - a certain risk for secondary contamination during the performance of the sterility test still persists either through contamination derived from the environment, the surrounding air or through the sterility test itself.

The risk for secondary contamination can be circumvented by professional handling of isolator technology, by employing well trained operators and by gaining awareness about secondary contamination.

The following report summarizes the experience gained with isolator technology for the performance of sterility tests over a time frame of 15 years. The emphasis is especially laid on the development of isolator technology in the sterility testing environment regarding future developments.