This study assessed the performance of the APAS Independence with PharmaQC analysis module to identify growth on TSA culture media. The study assessed the performance on 1,515 environmental monitoring plates collected at AstraZeneca's manufacturing facility during routine production. Results compared the output of the APAS PharmaQC analysis module with the human reading as the reference result.

The APAS PharmaQC demonstrated 100% sensitivity for microbial growth detection, including identifying additional true positive plates missed by normal reading. A false positive rate of 7.3% was achieved with the majority of causes of interference relating to interferences applied to the plate during processing (e.g. tape and labels applied to the plate, excessive text markings).

Case study

Date: July 2023

‍Authors: Giglio, S. and Hill, R.

‍Citation: Giglio, S  and Hill, R. 2023. APAS Pharma QC pilot secondary validation study. Case study.