Applying USP<1223> Guidelines As Part Of A Comprehensive RMM Validation

By Scott Morris, Azbil BioVigilant, Inc.

To effectively apply a Rapid Microbial Method (RMM) technique and leverage its value, the end user must match his or her application and requirements to the benefits and performance of the RMM.

Understanding the general approach to validation as well as the inter-relationships between personnel and their qualifications, guidance and regulations, statistics employed, test equipment, test protocols, and data analysis techniques enhances this evaluation. Through this holistic understanding, more robust dialogue can be fostered, and ultimately, a more successful adoption of an RMM technology may be realized.