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Rapid Microbiology and the Newly Revised PDA Technical Report No. 33
Michael J. Miller, Ph.D. President, Microbiology Consultants, LLC
For more than 30 years, the field of alternative and rapid microbiological methods (RMMs) has influenced the application of novel technologies across a number of industry sectors. In fact, much of the development of new instrumentation, software and analytical methods for the detection, enumeration and identification of microorganisms has been driven by consumer and patient needs within the food, beverage, environmental and clinical or health care industries. For the past 15 years, advances in rapid technologies have also encouraged the pharmaceutical, biopharmaceutical, medical device and personal care industries to validate and implement RMMs in place of their traditional microbiology methods within QC/QA labs and on the manufacturing floor.
Rapid methods are now being used for a wide range of applications. For example, a number of companies within the pharmaceutical industry have obtained regulatory approval to implement RMMs as alternative methods for finished product release testing (e.g., sterility), in-process and raw material bioburden analyses, environmental monitoring, Purified and Water for Injection (WFI) testing, endotoxin analysis, microbial identification and the detection of Mycoplasma.
Many currently available technologies provide more accurate, precise, and sensitive test results when compared with classical growth-based methods. Additionally, they may be fully automated, offer increased sample throughput, operate in a continuous data- collecting mode, provide significantly reduced time-to-result (e.g., from days or weeks to hours or minutes), and for some RMM platforms, results in real-time may be achieved. These methods have also been shown to detect slow-growers, dormant and viable but non-cultural (VBNC) microorganisms as compared with standard methods used today. Most importantly, a firm that implements an RMM in support of sterile or non-sterile manufacturing processes may realize significant operational efficiencies during the monitoring and controlling of critical process parameters, reducing or eliminating process variability, improving product knowledge and reducing risk to patients and consumers. Additional benefits may include the elimination of off-line assays and a reduction in laboratory overhead and headcount, lower inventories (raw
34 | | November/December 2013
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