Radiation Sterilization: Part 1

Tuesday November 05, 2024 from 10:00 to 11:20

Room: Guanacaste 1-2

RadSter 1.2 New guidance on bioburden characterization for radiation-sterilized products in 11137-1

Chris M Hardman, United States

Department Scientist
Bioburden/Radiaton
Nelson Labs

Abstract

New guidance on bioburden characterization for radiation-sterilized products in 11137-1

Martell Winters1, John Kowalski2, Chris Hardman3.

1Global Science Team, Nelson Laboratories, Salt Lake, UT, United States; 2Independent Consultant, Independent Consultant, New Jersey, NJ, United States; 3Bioburden/Radiation Department, Nelson Laboratories, Salt Lake, UT, United States

As a result of industry discussions, new requirements and guidance on bioburden characterization will be added to the new version of ISO 11137-1, particularly in 7.2 and A.7.2. This presentation will provide a summary of the additions and include the science behind its importance, as well as options on demonstrating compliance.


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