Manual reading of agar plates has evolved 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 analyse 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.
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 to the industry looking to novel technologies to drive a shift from manual processing to automation that 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
- 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. The 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.
With pressure from regulatory bodies on the rise with no end in sight, intelligent and flexible automated plate reading solutions are an important consideration for your environmental monitoring program to ultimately ensure your contamination control strategy is up to par. APAS Independence integrates 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. Reducing manual processes, increasing data integrity and ultimately strengthening your contamination control strategy for the safe manufacturing of your products.
Learn more about Clever Culture Systems and APAS Independence here.