Posters - Networking - Exhibition

Wednesday November 09, 2022 from 13:30 to 17:00

Room:

POS-30 What is considered conforming product for underdosed radiation-sterilized product?

Martell Winters, United States

Director of Science
Nelson Laboratories, a division of Sotera Health

Abstract

What is considered conforming product for underdosed radiation-sterilized product?

Martell Winters1, Aaron DeMent2, John Schlecht4, Kevin O'Hara3.

1Nelson Laboratories a division of Sotera Health, Salt Lake, UT, United States; 2Sterigenics a division of Sotera Health, Oak Brook, IL, United States; 3Sterigenics a division of Sotera Health, Ottawa, ON, Canada; 4Sterigenics a division of Sotera Health, Bridgeport, NJ, United States

For radiation sterilization, what is considered conforming product with respect to delivery of the minimum sterilization dose? For example, is 24.9 kGy conforming to a 25 kGy minimum sterilization dose? Logically, it seems that a 24.9 kGy dose does not incorporate any additional potential impact to patient safety. However, where is the cut-off point?

Answers to these questions will be provided through a mathematical assessment including reverse calculating the corresponding sterilization dose that would still result in a rounded SAL value of 10^-6.0 and 10^-6, depending on whether the SAL must be rounded to one tenth of the exponent, or to a whole number exponent. The rationales and formulas will be discussed along with showing examples and different options for rounding. If an industry-wide rationale can be established to easily assess product that is slightly underdosed, it could result in significant cost and time savings when these events occur.


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