Choosing the Most Suitable Sample Points for Particle and Microbial Monitoring

Time: 9:50 am - 10:10 am

Date: 29 April 2025

Theatre: Stream D

29-april-2025 09:50 29-april-2025 10:10 Europe/London Choosing the Most Suitable Sample Points for Particle and Microbial Monitoring

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… Read more »

Making Pharmaceuticals

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.

Speakers

  • Andy Worsick Sales Manager - UK & Ireland, Particle Measuring Systems - Society for Contamination Control

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