Flexibility In Sterility Testing And Managing Risks Of False Positives

By James Drinkwater, Bioquell UK Process & Compliance Director

Causes and effects of false positives and false negatives in sterility testing.
This paper reviews the background to false positives and false negatives associated with the sterility test process. It explores the potential causes of such results and suggests methods of mitigation. It also includes an insight into the role hydrogen peroxide vapor bio-decontamination technology can have on false positives and false negatives while indicating how this technology can also be used to eliminate them.