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Automating the Micro QC Lab. An interview with Steve Delity (Part 2)

Last week, I shared part of my conversation with Steve Delity, President and CEO of Rapid Micro Biosystems, on the benefits of automation in the pharmaceutical microbiology lab. The first topic focused on his take around the value of an automated lab. Next, we talked about the future of the Micro-QC lab.

Michael - You described a number of benefits for automation. In a perfect world, what would an automated Micro-QC lab look like?

Steve –
In a perfect world, automation for the QC Microbiology lab actually involves moving QC activities out of the lab and redeploying functions at or near the manufacturing line. This aligns with PAT (Process Analytical Technology) and lean operations paradigms. As an example, QC microbiologists would quickly review data, recognize the issues and be more proactive…essentially getting the information and turning the data into actions much faster than they have been able to in the past.

I recently spoke with a major pharmaceutical company that painted a vision of what is possible for the QC Microbiology lab. They talked about automated rapid detection as a “Kiosk” function, where the point of collection (sample acquisition) is consolidated with point of sampling (e.g., the central testing lab). Labor is streamlined with seamless integration to their LIMS system. It is a value-added process that frees microbiologists from taking samples and reading plates. By automating these activities we can realize improved reproducibility, a decrease in data entry errors and time spent on investigations.

The collection procedures are not yet automated, but automation exists today for the steps after collection, opening time for the QC microbiologists to work on other activities while the automation handles the repetitive actions of pulling and reading samples, and communicating results to data management systems, such as LIMS for other, non-QC stakeholders. In essence, the QC microbiologist is able to “walk away” after taking the sample, letting automation handle the rest.

Automated sample collection has started to catch on with products like Biovigilant in environmental monitoring; however taking an environmental sample is less complex than the other types of Micro QC sampling. Because microbiology sampling is a different animal than some automated sampling systems for analytical and conventional PAT systems, there is still work to do. The good news is that the success of lean micro lab operations will spark continued automation of microbiology processes. It is only a matter of time.

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