SKAN AG: Proof of a successful decontamination with H₂O₂

The use of isolators in the manufacture and quality control of sterile medicinal products has been a trend for years and has increased significantly as a result of Annex 1 of the EC GMP guidelines, which explicitly recommends the use of barrier systems. The core process in the application of isolator technology is fully automated decontamination, which can be carried out using various methods.

Dr. Timo Krebsbach, Martin Novák (SKAN AG) and Dr. Jennifer Isken (Novartis Pharma AG) evaluate the use of Chemical, Biological and Enzyme Indicators in assessing the efficacy of hydrogen peroxide vapour in a sterility isolator. The authors summarise the differences between indicators and how they can be used in determining H₂O₂ efficacy during the different stages of cycle development and validation, concluding that although these methods can be used individually, their combined use is not only more meaningful, but also allows more far-reaching conclusions to be drawn.