Krebsbach, Timo, Isken, Jennifer and Schönenberger, Miriam (2026) Environmental monitoring strategies in aseptic manufacturing. PharmInd.

Abstract

Environmental monitoring is critical to ensuring microbiological and particulate purity in pharmaceutical manufacturing, particularly for sterile and aseptically produced products. Cleanrooms classified by ISO standards provide controlled environments tailored to product risk levels. Contamination sources include personnel, environment, raw materials, and processes, necessitating robust monitoring to verify control effectiveness. Conventional methods such as settle plates and active air sampling remain standard, but rapid microbiological methods (RMM) employing biofluorescent particle counters (BFPC) offer real-time data and early contamination detection. Despite challenges in correlating traditional colony-forming units (CFU) with new autofluorescent units (AFU), RMM align with evolving regulatory guidance (e.g., Annex 1) and promise improved contamination control, reduced operator intervention, and expedited batch release, signaling a paradigm shift in environmental monitoring strategies.

Item Type:	Article
Keywords:	Annex 1, Contamination Control Strategy, Environmental Monitoring, Isolator, Rapid Microbiological Methods
Date Deposited:	13 Mar 2026 00:45
Last Modified:	13 Mar 2026 00:45
URI:	https://oak.novartis.com/id/eprint/59321