Cleanrooms and Environmental Control

Cleanrooms are highly purified and regulated areas reserved for the manufacture of contaminant-free medical products. Typically rated from Class 100,000 down to Class 10, cleanrooms designated for the manufacture of Class I, II, or III devices require strict temperature, humidity, and other environmental controls. Mechanisms such as sensors, exhaust systems, and particle-control equipment assist in maintaining a clean environment. Special garments and gloves are also required for employees working in a cleanroom environment in order to avoid contamination.