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Introduction
Rapid microbiology methods have long been essential tools of the clinical and food industry microbiology
laboratories.Along the same lines, with automation usually comes enhanced objectivity.Moreover, RMMs also show improved sensitivity, efficiency, selectivity, accuracy, high
throughput, and low false-positive rate, leading to higher efficiency.13 These features of RMMs provide an
opportunity to assess the significance of viable but nonculturable or stressed microorganisms.Therefore, more screenings and repeat tests
could be performed in all stages of production, improving the surveillance process.13 Real-time control and
early warning of contamination are essential before introducing raw materials and other product
components to the process, validating manufacturing, or distributing finished products.Swift diagnosis of infectious diseases by clinical labs and the need for prompt test results from
perishable food items have been strong incentives for the use of rapid methods.Traditionally, growth-based methods require growing microorganisms in media, which microbiologists must
examine visually, looking for colony-forming units (CFU) in solid media types and measuring turbidity in
liquid broths.Advantages of RMMs
The implementation of RMMs also provides interesting economic features, because of the significant
reductions in time to result over conventional methods.RMMs involves an easy-to-handle protocol, with a negligible production of waste, minimal operator
variability, reduced staff training requirement, and possibility of automation.Thus, RMMs can improve manufacturing consistency by
permitting faster implementation of corrective actions and fostering opportunities to improve the safety of
the process.Immediate reactions to contamination
Corrective actions can be taken earlier because RMMs provide faster results, thus enabling a more
proactive response to instances of microbial contamination and out-of-trend situations.Additionally, RMMs can assist in the design of more robust, automated
processes that could reduce the opportunity for contamination altogether.From a manufacturing perspective, a faster time to result can enable companies
to release raw materials quickly, transfer in-process work to the next stage, and bring finished products to
market, which can shorten the production cycle, reduce inventory requirements, and free up working
capital.One of the explanations offered by the
pharmaceutical industry for not using rapid microbiology methods is the uncertainty over regulatory
acceptance.The process of evaluating, validating and implementing rapid microbiology test methods can
be an expensive and time consuming task.Moreover, the shorter analysis time reduces the probability of
contamination, improving the robustness.Some rapid methods can help laboratories reduce worker subjectivity, and automated systems that provide test results in a clear, pass-fail approach can take the guesswork out of plating and waiting.2.3.4.
Introduction
Rapid microbiology methods have long been essential tools of the clinical and food industry microbiology
laboratories. Swift diagnosis of infectious diseases by clinical labs and the need for prompt test results from
perishable food items have been strong incentives for the use of rapid methods. The pharmaceutical
industry, however, has not been as quick to embrace rapid microbiology despite the potential advantages.
Faster microbiology test results would provide better control over the manufacturing process. More rapid
microbiology assays would also allow for earlier release of product. One of the explanations offered by the
pharmaceutical industry for not using rapid microbiology methods is the uncertainty over regulatory
acceptance. The process of evaluating, validating and implementing rapid microbiology test methods can
be an expensive and time consuming task. Industry has been reluctant to expend precious resources when
regulatory approval of the new method may be in doubt.
This article will provide an overview of microbiology testing in the pharmaceutical industry and will look at
where rapid microbiological testing methods could fit into the manufacturing process. The issues involved
with validation of rapid microbiology methods will be considered with regard to CDER review expectations.
Finally, current FDA initiatives that could facilitate the use of rapid microbiology will be described.
Advantages of RMMs
The implementation of RMMs also provides interesting economic features, because of the significant
reductions in time to result over conventional methods. Normally, the production cycle is stopped or a
product is kept until checking the absence of contamination. If the time to result is shortened, the product
would be more rapidly released. Moreover, RMMs allow continuous sampling and data collection and
provide time-sensitive outputs and real-time data analysis. Therefore, more screenings and repeat tests
could be performed in all stages of production, improving the surveillance process.13 Real-time control and
early warning of contamination are essential before introducing raw materials and other product
components to the process, validating manufacturing, or distributing finished products.
RMMs involves an easy-to-handle protocol, with a negligible production of waste, minimal operator
variability, reduced staff training requirement, and possibility of automation. They also facilitate research
through generating earlier results. Moreover, the shorter analysis time reduces the probability of
contamination, improving the robustness. A shorter time to result facilitates replication of an analysis if a
contamination or a strange result occurs. Thus, RMMs can improve manufacturing consistency by
permitting faster implementation of corrective actions and fostering opportunities to improve the safety of
the process. Moreover, RMMs also show improved sensitivity, efficiency, selectivity, accuracy, high
throughput, and low false-positive rate, leading to higher efficiency.13 These features of RMMs provide an
opportunity to assess the significance of viable but nonculturable or stressed microorganisms.
The Four Key Benefits of Rapid Micro Methods
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