Classification and Routine Environmental Monitoring for GMP Cleanrooms

The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation. In the case of Routine Environmental Monitoring, there is very little prescriptive advice and this lack of direct guidance leaves users struggling to know what to do and the temptation is to either create over-burdensome monitoring programs or to try to simply use the same monitoring plan as is used for classification. Both are incorrect. This webinar discusses the differences between GMP Cleanroom Classification and Routine Environmental Monitoring and explains how Beckman Coulter can help.

The webinar will help cleanroom users understand the following:

Learning Objectives:

  • The difference between cleanroom classification and routine monitoring.
  • The differences between EU GMP and N America CGMP for aseptic manufacturing cleanroom contamination control.
  • How Beckman Coulter can help routine environmental monitoring managers address the confusion.

Tony Harrison, Senior Marketing Manager

Tony is a global expert for Beckman Coulter Life Sciences, specializing in cleanroom routine environmental monitoring and adherence to GMP and ISO standards.