Risikominimierung von Sekundärkontaminationen durch Einsatz von Isolatoren bei Sterilitätstests
Sterilitätstests mit Isolatortechnologie zur Risikominimierung von Sekundärkontaminationen
Novartis Pharma AG, Stein (Schweiz)
Today, isolators are nearly obligatory in every up-to-date sterility test laboratory. The risk for secondary contamination caused by the analyst or through the environment can be minimized by using isolators to perform the sterility test. 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 persists either through contamination derived from the environment, the surrounding air or through the sterility test itself.
The risk for secondary contaminations can be circumvented through professional handling of the isolator technology, by employing well trained operators and by gaining awareness about secondary contaminations.
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 test environment regarding future developments.