Environmental monitoring 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 process provide important information about the state of contamination of the environment throughout various stages of production.
Current practice relies on the manual reading of these plates and has become subject to increased regulatory scrutiny over reader qualification, poor plate-handling procedures, and incomplete laboratory records1,2. New microbiology tools are emerging that automate the reading and reporting of agar plates collected from environmental monitoring. 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, an automated platform for reading environmental monitoring culture plates is being adopted by pharmaceutical manufacturers as an alternative to the manual method. The system uses artificial intelligence to read plates after incubation, providing highly accurate colony differentiation and counting, including automated flagging of any moulds or spreading organisms present on the plate.
With the recent addition of the contact plate application, APAS Independence is now the only fully automated technology capable of providing high-throughput, bulk processing of both contact plates (55mm) and settle plates (90mm) used for environmental monitoring in pharmaceutical settings.
The APAS Independence’s open platform is a flexible solution designed to be easily integrated with existing microbiology workflows, with minimal changes, features include:
- Bulk plate loading / unloading and processing without the need for adaptors
- High-throughput automation at 200 plates per hour
- Extensive performance validation completed following compendial guidelines
- No proprietary media, validated on plates from major media manufacturers
- Complete end-to-end digital microbiology solution with image retention for review
- Compliant software with full audit trail and digital approvals
With regulatory scrutiny on manual methods in pharmaceutical quality control on the rise with no end in sight, introducing intelligent and flexible automated plate reading solutions to the environmental monitoring workflow is critical to ensure continued compliance. APAS Independence integrates into current processes, allowing manufacturers to maintain existing validated protocols while upholding compliance, allowing for process optimisation without disruption to the workflow. With APAS Independence, pharmaceutical manufacturers can continue using their established culture media and incubation equipment while seamlessly integrating the automation of plate analysis and result documentation.
Learn more about how Clever Culture Systems develop the artificial intelligence modules behind APAS Independence in this webinar here.
References
- U.S. Food and Drug Administration. (2024). Inspectional Observations (Form 483). Retrieved from https://www.fda.gov.
- U.S. Food and Drug Administration. (2025). Warning Letters. Retrieved from https://www.fda.gov.