Abstract
ISO/TC 198 Working Group 2 is charged with the revision of ISO Standard 11137:1995. In reviewing dose setting Method 1, it has attempted to rationalize the selection of the lower limit of average bioburden for product to which Method 1 can be applied. Provisionally, this limit has been set at 1.0. The Working Group has also considered three proposals for handling sterilization dose selection for product with an average bioburden less than 1.0.
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