Choosing the Most Suitable Sample Points for Particle and Microbial Monitoring

Synopsis

Choosing the Most Suitable Sample Points for Particle and Microbial Monitoring – A Risk Based Analysis

This paper will start by explaining the difference between cleanroom classification and monitoring. It then considers EU GMP Annex 1 and looks at ways to select the correct viable and non-viable sample point locations when considering the installation of a Facility / Environmental Monitoring System in an aseptic manufacturing facility. Looking at what is reviewed in risk assessments, it then follows a journey through the process to illustrate a methodology of how sample points are defined and finishes with some practical examples.