Preliminary performance testing of the APAS® Independence with APAS® PharmaQC artificial intelligence system for environmental monitoring in sterile manufacturing.

Abstract: Microbiological methods remain deeply rooted in traditional practices and new technologies are being considered to improve the agility, accuracy, consistency, and data integrity within pharmaceutical laboratories. One such technology, APAS PharmaQC, is an autonomous plate reader that uses artificial intelligence to detect microbial growth on environmental monitoring plates without any significant change to ways of working. Pilot primary validation with a suite of model organisms has demonstrated levels of performance for Linearity, Accuracy, Ruggedness, Precision, and Limit of Detection that are in line with compendial guidelines. These data demonstrate that APAS PharmaQC can provide benefits to pharmaceutical laboratories conducting environmental monitoring.

White Paper:

Date: September 2023

Authors: Dr. Steven Giglio, Julie Winson and Rhys Hill

Citation: Dr. Steven Giglio, Julie Winson and Rhys Hill. Preliminary performance testing of the APAS® Independence with APAS® PharmaQC artificial intelligence system for environmental monitoring in sterile manufacturing. White Paper. Sep 23.