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Updated: Oct 1, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Experiences with microbiological validation of radiation sterilisation
1Isotron plc, Elgin Industrial Estate, Moray Road, Swindon SN2 8XS, UK. johnh@isotron.co.uk
Abstract:
Apart from process control, the two most critical activities associated with radiation sterilisation of medical devices are the dosimetric and microbiological analyses required to validate the process. This article discusses some of the problems experienced in the field of microbiological validation and highlights the coming changes to the standards.
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