Direct measurement methods can detect cell viability without requiring growth of the micro-organism.One example of a direct measurement method combines fluorescent labelling and laser scanning cytometry to enumerate organisms. FDA Experience Release Tests Microbial Limits Sterility Other Water Bioburden Environmental Monitoring Bryan S. Micro Methods Overview Traditional Methods (plate counts, mpn) simple inexpensive accepted Rapid Methods fast sensitive Bryan S. ) microbial limits acceptance criteria Sterility Test âFalse Positivesâ clear criteria for invalidation of test result Bryan S. FDA Initiatives Process Analytical Technology (PAT) Includes rapid micro Microbiology Subcommittee for ACPS GMPâs for the 21st Century Product specialists for inspections Dispute resolution process at Center level Bryan S. Meet with CDER Microbiologists Validation issues Filing requirements Submit applications containing rapid microbiology methods Bryan S. Mark Claerbout, Lilly Research Laboratories Warren Casey, Ph.
In 2000, the Parenteral Drug Association (PDA) published the first guidance document on how to validate and implement alternative rapid microbiological methods.
The authors stated: New microbiology methods can offer advantages of speed and precision for solving microbiological problems Neither corporate economics nor regulatory attitudes should be a barrier to the use of new testing technologies or different measurement parameters.
The evolution of sterility testing began in the 1930s when it was introduced for liquid products (USP XI) as a 7-day test using one medium at 37C targeted for human pathogens.
The third type of RMM is cell component analysis or indirect measurement; expression of certain cell components correlates to microbial presence.
One example is amplification of DNA or RNA by polymerase chain reaction (PCR).