International Journal of Mechanical Engineering

In the production process of sterile drugs, clean room and air-conditioning system are the key points of sterility assurance. The number of air changes directly affects the self-purification and decontamination rate and ability of the pharmaceutical environment, which is crucial to the protection of the pharmaceutical environment. At present, there are no mandatory requirements for the number of air changes in GMP regulations, national standard specifications, and ISO guidelines, and the standards are also different between references. This article will discuss the selection of the number of air changes from the main points of environmental control and practical cases.

Sterile; Clean environment; Ventilation frequency; Control points