Towards an automated approach for smart sterility test examination

SLAS Technol. 2022 Dec;27(6):339-343. doi: 10.1016/j.slast.2022.09.005. Epub 2022 Sep 30.

Abstract

As new technologies emerge, deep learning applications are often integral parts of new products as features and often as differentiating benefits. This is especially notable in commercial consumer products in everyday applications, such as voice assistants or streaming content recommendation systems. Due to the power and applicability of these deep learning technologies significant efforts are being directed to the development and integration of appropriate models into science and engineering applications to supplant analogue systems that may be highly prone to human error. Here we present an innovative, low-cost approach to advance sterility assessment workflows that are required and regulated within drug release/manufacturing processes. The model system leverages off-the-shelf hardware as well as deep learning models to detect and classify different microbial contaminations in test containers. The paired hardware and software tools were evaluated in experiments using common model organisms (C. sporogenes, P. aeruginosa, S. aureus). With this approach we were able to detect all three test organisms across 40 experiments, furthermore we were capable of classifying the present organisms with an average classification accuracy of over 87%.

Keywords: Anomaly detection; Artificial intelligence; Deep learning; Explainable AI; Machine vision; Sterility testing.

MeSH terms

  • Automation*
  • Deep Learning*
  • Humans