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.
