If your company has processes in place for Microbiological testing, you?ve likely heard of rapid microbiology methods (RMMs). If you?re aware of these alternative testing methods but still find yourself hesitant to let go of traditional testing, perhaps it?s time to learn what RMMs can do for you.
How RMMs Change the Game
RMMs make it possible to identify microbial risks at the source in real time by detecting contamination at much lower levels in a matter of hours. This translates to faster response times and targeted data about potential contamination risks, leading to better prevention methods. Less product is discarded with early detection, and contaminants can be isolated to one area of production, reducing the need to sterilize further down the production line. The wasted labor hours and production resources that often go into contaminated products during the long incubation periods for traditional testing methods are minimized. The result is a cleaner production line, fewer delays, better prevention, and more efficient use of resources.
With all the benefits that RMMs offer, why are they challenged as the current standard? The answer to that question has much to do with misconceptions about the RMM process and familiarity with the standard methods.
Misconception 1: Regulatory authorities do not accept RMMs.
The Truth: Not only do most regulatory authorities accept rapid sterility testing, many encourage its use. Authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Australian Therapeutic Goods Administration (TGA), and Japanese Pharmaceuticals recognize the benefits of RMMs and consider them to be a superior testing method because it detects contamination quickly and reduces contamination rates overall, leading to fewer public health and safety incidents and reducing the burden on their respective administrations.
Misconception 2: The regulatory approval process is difficult.
The truth: Rapid microbial detection is being explored as an alternative without inhibition from regulations. Many rapid detection platforms have evaluations published by the FDA, German Health agencies, and the French regulatory agency (AFSSAPS) already. In 2008, the FDA published Guidance for Industry defining validation criteria for growth-based RMM and 21CFR<610.9> describes “equivalent methods and processes” while stipulating a need for increased assurance that products meet microbiological standards. Relevant chapters have also been published by the USP and EP, including USP <1223> “Validation of Alternative Microbiological Methods,” Ph.EUR.5.1.6 “Alternative Methods for Control of Microbiological Quality,” and Ph.EUR.2.6.27 “Microbiological Control of Cellular Products.
Misconception 3: The costs associated with RMMs is prohibitive.
The truth: Due to the nature of rapid methods testing, contamination issues can be identified much earlier on the production line, immediately saving companies substantial costs in resources and labor dedicated to contaminated products that will ultimately need to be discarded. Instead, production can be stopped at an earlier point and preventative steps can be taken quickly to reduce current and future product waste.
Misconception 4: Lower detection levels increase production delays.
The truth: Lower detection levels allow you to catch potential contamination issues quickly and with a shorter incubation period, resulting in a faster response time and less delay to get back online. Repeated use of RMMs leads to better quality control overall, which can reduce contamination incidents and lead to fewer production shutdowns.
Quantitative Microbial Detection Options There are four common options for quantitative rapid microbial detection.
Direct Laser Scanning is used to detect microcolonies.
ATP Bioluminescence is capable of detecting microcolonies by using adenosine triphosphate (ATP) to produce luciferin. The enzyme luciferase then catalyzes oxidation of the luciferin, resulting in oxyluciferin and light.
Autofluorescence detects viable organisms by introducing a fluorogenic substrate, a non-fluorescent viability marker, which then reacts with nonspecific cellular enzymes, triggering fluorescence that can be used to identify a microcolony.
Nucleic Acid-based Technologies are commonly used as real-time PCR, allowing a few DNA molecules to be synthesized in a test tube and replicated many times over.
How Can RMMs Benefit You?
The use of rapid microbiology methods can reduce your company’s overhead while ensuring compliance with industry and regulatory standards and minimizing risk for public health crises. Faster testing methods make it possible to respond quickly to contamination issues, decreasing production downtime and allowing you to reduce product waste. Better identification of contamination sources improves targeted preventative measures, leading to greater long-term efficiency with fewer production delays. Increased accuracy and sensitivity eliminates the frequent need for retesting, further reducing associated costs and product waste.
Despite the misconceptions surrounding them, RMMs are proving to be a faster, cheaper, and more reliable method for identifying contaminants. With the current and growing acceptance of RMMs by regulatory agencies, companies have more incentive than ever to abandon the outdated traditional methods and switch to a superior alternative. If you’d like more information about your microbiological testing options, contact us and let us tell you more about how switching to RMMs can save you money.
Dr. Sam Sammane, PhD