The highlights of this presentation by a leading FDA-CDER authority on aseptic processing isolator systems include basic design and validation approaches as well as feedback by FDA inspectors on various isolator applications during pre-approval inspections.
It has been generally recognized for years that conventional aseptic processing has its drawbacks when compared to terminal sterilization of a sterile drug product and there is an FDA mandate to improve upon them. Isolation technology is one available means to help accomplish this.
An overview of conventional aseptic processing is presented and it addresses the key issues that corporate decision makers are faced with when implementing isolation technology, such as regulatory requirements and equipment validation focus areas.
This presentation reviews the principles of microbial monitoring in isolators, current US and European regulatory requirements for monitoring, and the means to achieve and maintain a germ free environment. The current means to monitor the air and surfaces in isolators is also touched upon.