Krebsbach, Timo, Isken, Jennifer and Novák, Martin (2025) Proof of a successful decontamination process with H2O2. PharmInd - Die pharmazeutische Industrie.

Abstract

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. Isolators are unbeatable when it comes to effectively preventing extrinsic contamination and therefore make a significant contribution to drug safety. The core process in the application of isolator technology is fully automated decontamination, which can be carried out using various methods. As different as the methods are, they are almost all based on the same active principle, the evaporation of liquid to gaseous hydrogen peroxide, which has proven to be the most suitable decontamination agent. To check the decontamination effect and thus the decontamination success of the system, tests are carried out throughout the life cycle of the system [1;2]. Regardless of the life-cycle stage (e.g. qualification, cycle development or re-qualification), different types of indicators are used to prove the system's performance. These indicators can be divided into chemical, biological and enzymatic indicators. They can be used individually, but their combined use is not only more meaningful, but also allows more far-reaching conclusions to be drawn.

Item Type:	Article
Date Deposited:	15 Oct 2025 00:45
Last Modified:	15 Oct 2025 00:45
URI:	https://oak.novartis.com/id/eprint/57712