Skip to main content

Challenges and Solutions for Performance Validation of Environmental Monitoring Automation

2023 ISCT Annual Meeting, Paris - 31 May – 3 June 2023

Poster CHALLENGES AND SOLUTION FOR PERFORMANCE VALIDATION OF ENVIRONMENTAL MONITORING AUTOMATION - ISCT 2023

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. 

Filename
Poster CHALLENGES AND SOLUTION FOR PERFORMANCE VALIDATION OF EM AUTOMATION - ISCT 2023.pdf
Size
2 MB
Format
application/pdf

POSTER CHALLENGES AND SOLUTION FOR PERFORMANCE VALIDATION OF ENVIRONMENTAL MONITORING AUTOMATION

Filename
Poster CHALLENGES AND SOLUTION FOR PERFORMANCE VALIDATION OF EM AUTOMATION - ISCT 2023.pdf
Size
2 MB
Format
application/pdf
bioMérieux ensures the safety of patients undergoing cell and gene therapies

Expert Interview

Faster drug release to address the patients’ needs

Our 3P® ENTERPRISE solution can really make a difference by helping a faster drug release to address the patients’ needs.” - Laurent Leblanc, R&D Manager

Dairy products on display

Environmental Monitoring

Leverage digitalization and automation to improve your EM process so you can optimize workflows and maximize ease-of-use.