Imagine making well-informed microbiological quality control decisions quickly and confidently, knowing that your data is fully supported and documented. Thanks to technological breakthroughs, this is now a reality rather than a wish list. By adopting a digitalized approach, you can drastically lower the chance of errors, optimize processes, and enhance product quality and patient outcomes.
So why are many laboratories still not using a digitalized approach to microbiological testing? The four-eye principle for plate or media result detection, required by local regulatory agencies for these manual microbiological processes, is a resource drain that could be patronizing to experienced microbiologists. Manual transcription and translation are prone to errors in critical data documentation, and the use of older, highly manual laboratory procedures is a deterrent to the acquisition of high-quality microbiologist talent. The effort to change to a digital solution is minimal compared to the continued use of inefficient practices.
Modernizing your lab will change the way microbiological quality control results are handled and establish new standards of excellence in your laboratory. This strategy should be at the forefront of your lab's agenda to meet patient safety, compliance, and quality control requirements.
In this exclusive conversation with industry specialist Stacey Ramsey, Senior Manager – Celsis® & Microbial Applications Lab at Charles River Laboratories, we explore how digital tools can enhance microbial QC laboratory operations.
Find out how to make microbiological analysis and compliance more straightforward than ever before, from automated technologies that improve data collection to advanced analytics platforms that offer useful insights.
Q: Can you tell us about your background in QC microbiology?
Stacey: My background is almost exclusively within pharmaceutical microbiological control. Throughout my career, I’ve had the opportunity to explore many aspects and processes, including how the laboratory synchronizes with manufacturing operations to release critical and high-quality products. Since joining Charles River within the Celsis brand, I have the privilege of leading the Microbial Applications lab. Our purpose is to demonstrate how Celsis is effective for our customers. One way we do that is by performing contract method validation services to enable more users to access and utilize our technology.
Q: You mention that your role enables more users to access Celsis. In your opinion, how does accessing this technology improve laboratory capability?
Stacey: One of the more overlooked ways that rapid microbial methods improve capability is through digitalization. Celsis provides an objective analysis of the microbial metabolite, adenosine triphosphate (ATP). Not only is this bioanalytical method faster than waiting for microorganisms to replicate to levels of visual turbidity, but it is objectively analyzed by an unbiased computer and hardware. This objective read that is digitally documented removes human bias from the result, which in turn assures better reliability.
Q: What is meant by microbial QC digitalization? What percentage of labs do you think are already fully committed?
Stacey: Digitalization means modernizing the laboratory to meet the expectations of people and organizations living in today’s technological age. If I were to guess, I think there are a good number of companies operating primarily within the digital space, but I also think there are many that are still using manual systems. We have a ways to go, but digitalization within QC is increasing, and laboratories that are not utilizing automation will fall behind in capability, compliance, and efficiency.
Q: What is the most common barrier driving resistance to digitalization in the lab?
Stacey: I think there is fear of disruption to existing systems, and also a misunderstanding of the elements that are required to validate digital systems. A lot of stakeholders know that it takes work to implement digital systems. However, I'm not sure if they recognize that this doesn’t have to be overly complicated. With the right expertise and experience, any laboratory can streamline its implementation of new systems. In fact, in the long run, it could make their working lives much easier.
That’s where my team can help. We recognize that hiring a team of experts who live and breathe these implementations every day is more efficient than teaching customer resources to do it once for the application. Our experts have learned through multiple implementations and validations how to handle these projects efficiently and with the highest level of quality.
Q: Is there a difference in handling non-conformances if derived from a manual result versus a digitalized one?
Stacey: Absolutely. A laboratory can never investigate a non-conformance in a manual system to the same extent that it can in a digital system. This is in terms of investigating root cause, characterizing the extent of the problem, or implementing impactful correction.
For example, the result itself may be more meaningful if collected from a digital system. This means that reading other metadata surrounding the final result, such as a coefficient of variance (%CV), can tell an investigator a great deal about whether a result is reliable or not. These types of nuances may not be available with visual observations or paper-based results.
Q: How do you measure the impact of digitization on the laboratory's microbial quality control processes? What key performance indicators (KPIs) would you consider?
Stacey: Quality metrics and labor. When digitalization is done correctly, the number and types of exceptions or non-conformances decrease. This includes laboratory problems like invalid assays and manual result transcription errors, but also true results indicating that processes are not in control. In terms of labor, we can also measure how analysts spend less time in the lab completing tasks. Their throughput increases, and their engagement may even improve as they focus on more critical tasks.
Q: What are your experiences with helping labs implement digitalization, and can you share a specific example?
Stacey: Our team has assisted many Celsis implementations over the last five years or so. Some of our biggest impacts have been within emerging markets, especially 503(b) compounders. In one case, one of these compounders hired us without understanding what an alternative microbiological method validation entailed. We finished validation within 3 months, and then they were able to launch a sterility test program using Celsis ATP-bioluminescence across their portfolio. As a compounder, this means that this company is able to distribute some of the most critical small-molecule hospital drugs to patients only 7 days after manufacturing. This was not possible before implementing Celsis.
Q: What does the future hold for lab digitalization, and does AI play a role in the outcome?
Stacey: We’re already seeing AI used to develop new software capabilities that, in turn, improve capabilities even further. I’m not sure how far we go with it, though. The human element is still a highly important part of critical thinking through processes that I hope we continue to access.
Overall, I think that manufacturers and quality inspectors will demand the digitalization of pharmaceutical manufacturing and of other personal care products. These medicines save human lives, and mistakes are not tolerated. Once we embrace these tools and use them properly, we improve not only our working lives but also the lives of our customers and their patients who receive these important products.
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About Stacey Ramsey - Senior Manager, Celsis & Microbial Applications Lab, Charles River Microbial Solutions
