USP , EP 5.1.6 and PDA TR33 all require Specificity for the validation of alternative qualitative sterility test methods. Identifying a panel of organisms to perform Specificity testing and evaluation of RMMs beyond the pharmacopeial recommended organisms has been a challenging endeavor given the varying nature of environmental isolates and the inherent risk that what has been recovered at your site today may be different than what is recovered in future. This study outlines the approach taken by Rapid Micro Biosystems in identifying and testing a broad and comprehensive range of organisms to support the development of the Primary Validation for Growth Direct® Rapid Sterility to include those described in the regulatory chapters as well as those commonly cited by industry literature as being challenging and relevant. This study also aims to characterize the effects of a common stress application on the Growth Direct Rapid Sterility System's detection capabilities.
Sem et al. (Thu,) studied this question.