Group B

Wednesday November 06, 2024 from 15:45 to 16:30

Room: Central

310 New computer simulation approach for evaluating appropriateness of verification and sterilization doses for low-bioburden products

Martell Winters, United States

Director of Science
Nelson Labs

Abstract

New computer simulation approach for evaluating appropriateness of verification and sterilization doses for low-bioburden products

Martell Winters1, John Kowalski2.

1Global Science Team, Nelson Laboratories, West Valley, UT, United States; 2Independent Consultant, Independent Consultant, New Jersey, NJ, United States

Population C, the Standard Distribution of Resistances (SDR), underpins radiation sterilization dose establishment methods Method 1 and Method VDmaxSD. First described in the early 1980's, its universal relevance to currently produced medical products has been discussed at various standards meetings. A newly developed set of microbial distributions has been developed and computer-based simulations performed with Method 1 and Method VDmaxSD. These distributions differ in structure from those previously published and were targeted to represent possible "real world" deviations from the SDR. The simulations included a range of average bioburden values and increasingly resistant microbial distributions.


If you have any questions, please email us (info@imrp2024.com) or come to the onsite registration desk.
© 2024 IMRP