Whitepaper: Designing an environmental monitoring solution for GMP

A review of current environmental monitoring practices to ensure that monitoring systems comply with the latest EU GMP Annex 1 2022.

This whitepaper is an excerpt from the Facility Monitoring Systems Chapter of the Environmental Monitoring Handbook from Particle Measuring Systems. It was written and is being made available at no charge to support the advancement of global good manufacturing practice (GMP).

Cleanroom classification

Pharmaceutical cleanrooms are classified according to the particle concentration of the air that is required to meet the cleanliness criteria for the manufacturing process being performed. The determination of the cleanroom class is based on actual statistically valid measurements and is a function of the filtration and operational status of the room. In essence, it is a calibration of the room to ensure it meets its intended classification. It is not, primarily, a function of the risk of an application.2