Rapid Microbiological Methods - improve the detection, quantification and identification of microorganisms in the product

• By: Admin
• Date: December 08, 2009

Rapid Microbiological Methods (RMMs) are methods designed to provide performance equivalent to the sterility testing methods described in 21 CFR 610.12, while providing results in significantly less time. In general, RMMs are based on technologies which can be growth-based, viability-based, or surrogate-based cellular markers for a microorganism (i.e., nucleic acid-based, fatty acid-based). RMMs are frequently automated, and many have been utilized in clinical laboratories to detect viable microorganisms in patient specimens. These methods reportedly possess increased sensitivity in detecting changes in the sample matrix (e.g., by-products of microbial metabolism), under conditions that favor the growth of microorganisms.