Environmental monitoring (EM)

Routine sampling of air, surfaces and personnel to verify that cleanrooms remain in a state of microbial and particulate control. EM uses active air sampling, settle plates, contact plates, swabs, glove prints and particle counters, at locations and frequencies set by risk assessment. Results are compared with alert and action levels and trended over time. EM does not make product sterile, but it shows whether the controls that protect product are working.