Sterility Testing Advantages Using Isolator Technologies

By Matt Pridden, Extract Technology

Sterile production needs to be performed under HEPA filtration creating a grade A environment. A sample batch is removed from the production run for sterility testing. Methods to do this have often been under the same conditions i.e. laminar flow cabinet. However, more and more testing laboratories are opting to carry out sterility testing in bio decontaminated environments, often using an Isolator decontaminated with hydrogen peroxide. The move from sterility testing within LAF safety cabinets to those in aseptic isolators has resulted in a marked decrease in false positive results