Evaluating the APAS Independence System for Automated Microbial Detection in Environmental Monitoring: Poster presented at PDA Microbiology Conference 2025.

Automated microbial detection systems are becoming increasingly essential in pharmaceutical manufacturing to enhance efficiency, accuracy, and compliance with Good Manufacturing Practice (GMP) standards. The APAS Independence System, developed by Clever Culture Systems, was evaluated at Bristol Myers Squibb (BMS) to assess its suitability for environmental monitoring applications. The APAS system is capable of automated plate counting of both 55 mm and 90 mm plates, following an offline incubation at routine EM parameters. The study compared APAS automated colony counts to traditional manual counts for compendial strains and environmental monitoring samples across multiple weeks of EM sampling. Performance metrics for both plate sizes were analyzed, such as accuracy, precision, false negative and false positive rates, and robustness. The APAS system demonstrated high accuracy (≥70%) and reliability for most tested organisms. Therefore, the system is being implemented for GMP use, with a validation approach that combines vendor validation of the Artificial Intelligence with site specific instrument qualification. This evaluation provides insight into the capabilities and limitations of automated colony detection, informing future digitalization strategies in microbiological quality control.