How To Design An Environmental Monitoring Solution For cGMP Pharmaceutical Manufacturing

By Mark Hallworth

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. After a cleanroom has been tested for compliance with cleanroom classification, the classification achieved dictates which production activities can be performed in that cleanroom or clean air device.

Once a cleanroom or clean air device has been proven to meet the requirements for cleanliness by certification activities, it must also be demonstrated that this control can be maintained throughout production periods. The environment must be rigorously monitored to ensure there is full and constant awareness of current conditions, including the detection of periodic events.

Environmental monitoring should be performed using suitable techniques that meet the needs of the risk assessment. Learn about environmental monitoring requirements, features typically included in the instrumentation used in constructing an integrated solution, and more.