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RAPID METHODS SUPPLEMENT


A REGULATORS VIEW OF RAPID MICROBIOLOGY METHODS


Bryan S. Riley Senior Review Microbiologist, US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science


Microbiology plays an important role in pharmaceutical manufacturing. Bioburden monitoring of drug product components, in-process samples, pharmaceutical development tests (e.g., antimicrobial effectiveness), environmental monitoring, and finished product testing (e.g., microbial limits or sterility) are significant factors for ensuring product quality. However, the microbiological test methods used by most of the pharmaceutical industry today have changed little since their creation in the 19th Century. Inoculating broth cultures for sterility tests followed by periodic observation for turbidity and counting colonies on agar plates are familiar tasks to all pharmaceutical microbiologists.


Although these traditional methods have their advantages (simplicity, low cost, widely accepted), they suffer from one serious drawback; the results from the traditional microbiological test methods may not be available in a timely fashion. Because the traditional microbiological methods require microorganisms to grow to levels that can be detected visually, (turbidity or visible colonies) the time to results can range from two to three


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“One of the validation parameters for a RMM that stimulates a great deal of discussion is specificity”


days (plate count) to 14 days (sterility test) or even 28 days (Mycoplasma). In order to use the results of microbiological tests to control a manufacturing process and thus ensure acceptable microbial quality, the results need to


be available in a timely fashion (e.g., during processing). Timeliness does not necessarily mean real-time results; often even a modest reduction in time to results can be useful. The definition of ‘timely’ will vary with the specific circumstances and must be determined by the user. There are a number of commercially


available Rapid Microbiology Methods (RMM) that rely on a variety of mechanisms to detect microorganisms. Some of these RMM require an enrichment phase of microbial growth before microbial detection using an alternate mechanism instead of visual detection. Some examples of these alternate mechanisms include ATP Bioluminescence, CO2


increase and


micro-colony detection via auto-fluorescence. These growth-based RMM can provide faster results than the traditional methods because the detection mechanisms are more sensitive than


European Pharmaceutical Review 03 Volume 16 | Issue 5 | 2011


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