Several industries, ranging from pharma, personal care and food producers to healthcare and water providers, are seeing the benefits of new rapid microbial methods (RMM) that help to ensure products and services are free of dangerous microbes. Whereas traditional methods of culturing samples may take weeks, today’s new technologies can identify pathogens in hours, enabling companies to take fast action to stop contaminated products reaching the public.
The shift by regulators towards quality by design, PAT and risk-based approaches for product and process development is also facilitating the use of the latest RMM in routine monitoring.
In future, the use of more accurate microbial identification methods along with gridding studies of the manufacturing plant and routine screenings will enable re-occurring excursions of the same organism to be recognised and rectified in “real time”.
However, it is not all plain sailing. The more sensitive the techniques become, the more microbes are picked up, requiring greater data handling and understanding of the hazards and risks of each. We need to know precisely what we are dealing with. The species name alone may not provide the appropriate evidence to develop a response to a contamination event if there is the potential for multiple strains as sources. It will in future be necessary to differentiate microbial flora to the sub-species or strain level to definitively determine the source (see p33–34).
Meanwhile, the technology gets ever smaller – Oxford Nanopore’s latest device for the analysis of DNA, RNA and proteins in the field is not much bigger than a portable USB.