Particle monitoring requirements in pharmaceutical cleanrooms

Published: 1-Oct-2010

GMP regulations require that these environments are rigorously monitored to ensure that there is full and constant awareness of current environmental conditions, both for viable and non-viable contamination

Why do I need a Particle Counter?

This is a frequently asked question from current or potential pharmaceutical cleanroom personnel. The legislation and cGMP guidelines clearly state why microbiological monitoring must be performed and impose limitations for production environments. Little mention is made of routinely monitoring the particle count levels. So what value does it add and why should I be doing it?

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