[A centralized system of particle counting in controlled zones]

The air quality is the primary concern of the environmental control program in aseptic operations of pharmaceutical industry. The article reports on the development of the air particulate monitoring in the sterile manufacturing areas. In this respect, it presents a new approach which provides more assurance of acceptable air quality in the immediate environment of the manufacturing process and puts the emphasis on the preventive aspect. This approach is now possible by using available advanced systems which permit a continuous and simultaneous airborne particulate monitoring of critical manufacturing areas.