Dose Establishment - Are we asking the right question?
bradley lundahl1.
1MQSA, Johnson & Johnson, Peoria, AZ, United States
The predominant radiation sterilization industry dose establishment/substantiation methods are captured in the ISO 11137-2. Specifically, method 1, methods 2a/2b and VDmax25 and VDmax15. Additional VDmax doses are identified in AAMI TIR33, and most recently in ISO 13004. The two most widely used are method 1 and the VDmax method for various doses. The latter are based on population C (SDR). The following presentation will evaluate the assumed correlation of bioburden to sterilant resistance, the question answered by a null hypothesis test (NHT) verification, the associated restrictions of these methods, their verification forecast performance as well as suggest what question should/could industry be asking with respect to sterilization dose establishment/substantiation.
