Modernizing Growth Promotion Testing using APAS® Independence: Poster Presented at PDA Week 2026.

Journal: PDA journal of pharmaceutical science and technology
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Abstract

Agar-based methods remain a cornerstone of environmental monitoring in cleanroom environments due to their unmatched ability to detect viable microorganisms. The Growth Promotion Test (GPT) remains a regulatory requirement to verify the performance of each new batch of culture media. While the use of freeze-dried organism pellets has improved inoculation accuracy, colony enumeration is still largely performed manually, introducing variability and potential for human error. This presentation explores how the APAS Independence system leverages artificial intelligence (AI) and advanced imaging techniques to streamline GPT workflows. By mitigating common sources of counting inaccuracy such as lighting, plate markings, and user fatigue, APAS technology delivers consistent, auditable results that integrate directly with laboratory information management systems (LIMS) for compliance with 21 CFR Part 11. Beyond improving accuracy and efficiency, the system enhances traceability and supports long-term performance trending, making it a valuable tool for modernizing GPT without disrupting existing procedures.

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