Increased regulatory focus on environmental monitoring (EM) in pharmaceutical manufacturing has intensified the need for the development of alternative microbiological methods to meet demands no longer being met by compendial manual methods. This presentation demonstrates the responsible development and validation of artificial intelligence (AI) for automated culture plate reading, using the APAS® Independence system as a case study. It outlines how AI-powered automation can improve consistency, efficiency, and data integrity in EM workflows while upholding GMP requirements.

The presentation aligns AI development with evolving regulatory expectations, including FDA initiatives, EU GMP Annexes, and ISPE GAMP AI guidance, emphasizing risk-based controls, deterministic performance, and lifecycle management. Key elements include representative training data, microbiologist-led model development, and primary and secondary validation strategies. The case study demonstrates that, when governed appropriately, AI-enabled automation can drive meaningful operational improvements for EM programs.

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Presentation: Clever Culture Systems

Conference: PharmaLab Congress 2025

Date: 25 November 2025

Presenter: Dr Steven Giglio, Chief Scientific Officer, Clever Culture Systems

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