TESTING MANUFACTURING ENVIRONMENT
It is important to be able to accurately identify these organisms of interest to assess either the possibility of their viability, or if they are likely to be pathogenic, producing hazardous toxins and/or causing disease that can adversely affect consumers.
THE CONSEQUENCES OF OUTDATED METHODS Error-prone methods or processes that lack sound science can yield inaccurate data, cause investigations to go in circles and result in inconclusive or incorrect decisions. All of these situations not only waste time and money but also increase the risk to consumer safety. Accurate microbial identifications are dependent on the method, how that method is executed, how the data is analysed and the quality of the reference library.
There are many technologies utilised to characterise or identify microorganisms isolated from manufacturing environments (eg, phenotypic methods like gram staining, genotypic, etc) and being aware of the limitations of these technologies is vital.
Basic characterisation, such as a gram reaction, gives general information about the likely source of the contaminant, but more detail may be required to fully understand the risks to your products. It is also recognised that the gram-stain procedure is one of the most frequent causes of incorrect identification of bacteria. The gram- staining reaction observed from a bacterial strain does not always correspond to its gram type, and the multiple steps and controlled times required for each step mean there is potential for analyst error, as well as a subjective interpretation of results. Each of these steps in the gram-stain process has the potential to provide incorrect findings. Maintenance of data integrity and quality is difficult when the data is subjective. Gram-staining is often the first step in microbial identification in consumer care product manufacturing, and an inaccurate gram ID can lead to erroneous results with lost time and lost profits.
Different methods of identification have varying levels of accuracy. For example, it has long been recognised that genotypic methods are the gold standard for microbial identifications, providing the highest confidence in accuracy and precision versus commercial phenotypic methods. However, this method can be costly and work intensive. An alternative to genotypic methods is the The MALDI-TOF (Matrix-Assisted Laser Desorption Ionization – Time of Flight) mass spectrometry technology, the MALDI Biotyper, which has become widely accepted across industry segments as the next generation of microbial identification with fast sample prep and testing time.
The MALDI-TOF system for microbial identification is accurate, rapid and cost-effective. Both genotypic and proteotypic methods provide higher accuracy from the conventional phenotypic
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methods like gram-staining. You can reduce risk to your products when you rely on a more accurate identification method. However, an identification system is only as powerful as the library database coverage that supports it. When an identification system does not have sufficient database coverage, it will either yield ‘no match’ or ‘no identification’, and even an inaccurate identification can be reported. Inaccurate data causes faulty risk assessments, which are potentially worse than no identification determined.
Many commercially available systems were developed to address clinical applications and have a focus on clinically relevant species in their libraries and are not comprehensive enough to generate accurate identifications. It is pertinent that the identification system’s database contains a robust library of microorganisms relevant to the products you are manufacturing in your industry.
WHERE CHARLES RIVER LABORATORIES CAN HELP
Charles River Laboratories’ long-standing industry experience and quality technology define the products and services we provide to keep manufacturing running at the highest quality. For 30 years, Celsis Rapid Microbial Detection methods have been able to detect microorganisms to confirm quality products in as a little as 24 hours, significantly reducing production time. Depending on the instrument used, Celsis can run 30 to 120 assays per hour, cutting days off the production cycle to get products on the market quickly, safely and with the quality that customers demand. Celsis can revolutionise how you get your product to market.
As for microbial identifications, Accugenix microbial identification and strain typing services are highly regarded in the industry. PhD-level scientists are behind the creation of robust and validated assays.
Charles River Laboratories’ library database is constantly being updated and contains the most comprehensive bacterial and fungal species found in today’s industrial production and research environments, ensuring samples’ ID accuracy. By using these two technologies, facilities can benefit from fast microbial detection with a harmonised identification programme to help get safe products into the hands of consumers, quickly
Author Charles River Laboratories
www.criver.com/ personal-care-and- cosmetics
cosmeticsbusiness.com
Error-prone methods or processes that lack sound science can yield inaccurate data
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