Biological Contamination Events In Isolators: What Lessons Can Be Learned?

By James Drinkwater, Bioquell UK Process & Compliance Director

Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. This paper considers a range of ‘real-life’ biological contamination event cases studies, reviews the root causes that were identified and looks at what lessons can be learned.