Executive Q&A: Automated Microbiological QC Workflows Will Likely Become Commonplace

What is driving the trend toward automation in microbiological QC?

Anke Hossfeld: We see resource limitations and the need to improve efficiency as the main drivers. The populations of most advanced economies are aging, so many pharmaceutical QC departments are already struggling to attract, maintain, and train the personnel they need. This situation is likely to exacerbate in the coming years because, over the same period, the overall quantity of QC testing is predicted to increase. An automation solution can reduce the need for the additional skilled personnel that companies would have to hire.

Anne Weeks: Experienced staff prefer to be assigned higher-value tasks rather than repetitive activities, many of which can be performed more reliably by automation systems or robots while those higher-value tasks remain. Another trend is that the value of batches is increasing, particularly where biologics are manufactured, so the consequences of losing a batch are becoming graver. And then there are the continuing price pressures due to ever-increasing worldwide competition in the pharmaceuticals market.

What do manufacturers of pharmaceuticals stand to gain from automated QC solutions?

Anne Weeks: Laboratory robotics and automation systems operate tirelessly and with precision, and their standardized motions are the same, day in and day out. This reduces the risk of human errors and cross-contamination, thus improving the robustness of the test as false positives decrease. Investigation times and costs are lowered due to anytime availability of comprehensive test data, and fewer batches lost, together boosting overall productivity. What the coronavirus bottleneck taught us is that you must strive to get it right every time, as well as possess the capacity and flexibility to increase throughput at short notice.

Anke Hossfeld: Automation and robotics come with digitalization, which is both an enabler and an amplifier of efficiency gains. Automated data recording at each step of a test’s workflow, from selecting stored materials to sample collection, testing, incubation, and result reporting, ensures full data integrity and traceability.

In addition to facilitating compliance, the captured data can be analyzed to track trends and spot deviations. This eases and speeds up investigations into out-of-specification results. Digitalization alone improves lab efficiency by optimizing scheduling and reducing manual documentation and investigations; in combination with automation, it delivers even greater value by reducing human interactions that can cause secondary contamination and production stoppages.

Will we see the automation of all microbiological QC workflows?

Anne Weeks: Not all workflow steps are suitable for robotics, automation, and accompanying digitalization, so some are going to stay manual, for example where testing volumes are too low. It’s also important that manufacturers keep the capability to perform manual testing when maintenance is performed on the automated system as well as for validation and revalidation purposes - they constantly have new matrices to deal with. So it’s not either manual or automated testing, they complement each other. However, automated microbiological QC workflows will likely become commonplace.

Anke Hossfeld: To assess the suitability for automation, we reviewed and analyzed the manual workflows involved in testing to discover which steps are best addressed by a robotic arm or an automated component. It became clear that our instruments and many of our consumables would need to be adapted. All of the elements of an automation solution must be integrated, meaning physically brought together, assembled, programmed, and connected to the company’s IT architecture. The outcome can, for example, be a set of technology modules in a dedicated, multi-compartment cabinet that is then installed in the facility, or a mobile robot that can be used at multiple locations.

For which microbiological QC workflows is MilliporeSigma developing automation solutions?

Anke Hossfeld: In cooperation with customers and engineering partners, we have already developed fully functional prototypes for environmental monitoring and bioburden testing. Our aim now is to standardize them, which will make validation and life-cycle management easier. For multinationals, it makes sense to implement an automation solution at several of their facilities around the world, saving them the effort and costs of having to fully evaluate, plan, and validate very different QC methods everywhere. We went into more detail on the automation prototypes in our article, and also in this issue.

Anne Weeks: For sterility testing, customers use very different protocols and consumables, but it is critical that they follow the usually quite complex SOPs precisely. Contemporaneous documentation is hardly possible while working in an isolator, so we have based our M-Trace® solution for sterility testing, which was recently launched in the market, on automated software and data handling to ensure traceability and avoid handling errors. It guides the operator through a customized and digitalized testing SOP, giving step-by-step instructions and recording user feedback automatically.

Find out about MilliporeSigma’s strategy of developing automation and robotics solutions to build the smart QC laboratory of the future.

Author Details 

Anne Weeks and Anke Hossfeld share insights on why and how automation and robotics will change microbiological QC in pharmaceutical manufacturing.

Publication Details 

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