In this case study, the approach to global validation and introduction of an alternative microbiological method is presented. It describes how AstraZeneca have industrialized and introduced automated colony counting technology for their large volume environmental monitoring QC laboratories. The workflow allows for “walk away” processing of samples following incubation, where the instrument scans the sample barcode, reads the result, enters the count into LIMS and processes the agar plate for further analysis or discard. The APAS Independence was chosen and validated in one location as part of a global validation strategy to introduce the system at multiple locations within AstraZeneca

The approach to industrialization, global validation, IT system integration as well as the project learnings and workflow development is presented. The presentation shares the realized benefits of APAS Independence and how a global approach to technology introduction can be used to streamline the modernization of pharmaceutical microbiology.

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Presentation: AstraZeneca

Conference: PDA Pharmaceutical Microbiology Conference 2025

Date: 28 October 2025

Presenter: Phil Duncanson, PhD, Senior Director, AstraZeneca