Simplifying the substantiation of the sterilization dose using VDmax SD-S
Martell Winters1, John Logar2.
1Global Science Team, Nelson Laboratories, Salt Lake City, UT, United States; 2Microbiological Quality and Sterility Assurance, Johnson & Johnson, Raritan, NJ, United States
This presentation provides an alternative, simplified method to substantiate a sterilization dose using VDmax SD-S, including the calculation tool provided with AAMI TIR76. This approach allows for two or three pre-established verification doses, selected based on a general understanding of the product bioburden, and uses the outcome of the tests to determine the minimum sterilization dose. This could allow for a faster and simpler establishment of sterilization dose.
