Viable Monitoring in Cleanrooms

Once a cleanroom facility is qualified, a routine environmental monitoring program must be designed, which includes identifying sampling locations, determining the frequency of monitoring, and conducting trend analysis. The environmental monitoring program should also outline procedures for facility cleaning, plate transfer, operator training, and failure investigation. A viable monitoring program should be established in all sterile manufacturing environments and documented. Viable particle monitoring is designed to detect viable particles, which usually include bacteria and fungi. The program is designed to detect…