Formal methods of selecting monitoring locations and control levels

Abstract

It is necessary to determine locations in a cleanroom where airborne concentrations of particles and microbe-carrying particles (MCPs) should be monitored. It is also necessary to determine the concentrations of airborne contamination that should not be exceeded during manufacturing operations, ie. the alert and action control levels. Both these requirements can be ascertained by simple and informal means. However, should a formal approach be required, the monitoring locations can be determined by a risk assessment, and the control levels by a statistical method. Key Words: Monitoring, airborne particles, control levels, pharmaceutical, cleanrooms