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Updated: Sep 25, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Practical experience of microbiological validation of sterilisation
1Isotron plc, Swindon, UK. john.harries@isotron.com
Abstract:
The addition of the VDmax method provides manufacturers with a choice of three microbiological validation methods to substantiate a 25 kGy sterilisation dose. This article reports on experiences of applying these methods and suggests ways to handle difficult products.
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