From 483s to compliance: Intelligent automation is the future of pharmaceutical environmental monitoring
In the ever-evolving landscape of the pharmaceutical industry, intelligent automation has emerged as the transformative force shaping the future of manufacturing processes. Among these, environmental monitoring (EM) stands at a crucial crossroads, where the shift from traditional methods to cutting-edge technologies is not just an option but a necessity. As manual plate reading, a long-standing practice, undergoes significant changes, it has triggered heightened scrutiny from the FDA, underscoring the urgent need for industrial automation solutions. Recent 483s issued by the FDA have spotlighted issues such as reader qualification, subpar plate-handling procedures, and insufficient instrument qualification, making it clear that the status quo is no longer tenable. In response, the pharmaceutical industry is increasingly turning to novel automation equipment and intelligent automation systems to alleviate regulatory pressure and optimize workflows. So, how does one embark on the journey from manual plate reading to a more automated and compliant EM process?
Manual reading of agar plates has undergone significant evolution over the years, resulting in increased regulatory scrutiny throughout the pharmaceutical industry. More specifically, the FDA has recently issued 483s concerning the qualification of microbiologists who analyze agar plates, the lack of proper procedures for handling plates during the plate reads, and the instrument qualification used to perform plate counts. Although many types of plates are used for various test methods in pharmaceutical microbiology, regulatory actions have focused on environmental monitoring (EM) of classified areas where viable air and surface sampling play an important role in ensuring the safe production of drug products.
EM plays a vital role in the manufacturing of safe medicinal and other regulated products. Traditional methods include the use of 90mm settle plates and smaller 55mm contact (or RODAC) plates, which remain the gold standard for the viable sampling of air, surfaces and personnel. Results from this sampling can provide essential information about the state of contamination of the environment throughout the various stages of production. However, concerns over human errors in plate colony counts and transcription of results, as well as potential data integrity issues, continue to drive apprehension regarding manual methods. This has led the industry to look towards novel automation equipment and intelligent automation technologies to facilitate a shift from manual processing to industrial automation that effectively addresses these issues.
New microbiology tools are emerging that automate the reading and reporting of plates collected for EM. These new methods typically capture a plate image and use advanced digital tools to interpret growth on the plate and identify individual colonies. This helps improve overall manufacturing processes by offering greater traceability and data integrity of every result, improved throughput and efficiencies for releasing environmental monitoring results, and fully digital workflows enabling a paperless environment.
Clever Culture Systems APAS Independence automation technology, powered by artificial intelligence, provides highly accurate colony differentiation and counting, including automated flagging of any moulds or spreading organisms present on culture plates. This intelligent automation system utilises a flexible design that does not require proprietary media, allowing for ease of implementation into the EM workflow while reducing manual processes and increasing data integrity. Building on an established validated platform, APAS technology is now available to automate reading of both contact and 90mm plates on a single hardware platform. With the addition of contact plates, APAS Independence is now the only fully automated technology capable of providing high-throughput bulk processing of both contact and 90mm plates used for EM in pharmaceutical manufacturing.
As the pressure from regulatory bodies continues to mount with no end in sight, intelligent and flexible automated plate reading solutions have become an indispensable consideration for any environmental monitoring program. Embracing industrial automation and intelligent automation systems like APAS Independence is not just about staying compliant; it’s about future-proofing your manufacturing processes. These automation equipment solutions seamlessly integrate into your current processes, allowing you to maintain your existing validated protocols. You can continue using your established culture plate media and incubation equipment while APAS Independence handles the automation of plate analysis and result documentation. By reducing manual processes, increasing data integrity, and ultimately strengthening your contamination control strategy, intelligent automation paves the way for the safe and efficient manufacturing of pharmaceutical products, firmly establishing itself as the future of pharmaceutical environmental monitoring.
