Challenges and solutions for Performance Validation of Environmental Monitoring Automation

Introduction

Environmental Monitoring (EM) is crucial to assure patient safety. The visual end point reading of petri dishes has been used for decades without a true performance assessment. Automatization technologies are more present and improve EM practices.

3P® STATION is a colony counter system based on automatic timely plate reading incubation. It is part of the global 3P® ENTERPRISE solution for EM. This instrument intends to automatize the current traditional method for monitoring microbial levels in pharmaceutical production areas, preserving its analytical performances. How to validate those analytical performances?

There are many existing guidelines for microbiological method validation. But those guidelines are product testing oriented and do not address the subject of EM. Concerning EM methods, there are very few harmonized guidelines covering the analytical methods and even less covering their validation. The first step was to define a relevant validation strategy using new adapted tools/metrics to the 3P STATION intended use.