Environmental monitoring (EM)

Routine monitoring of air, surfaces and personnel in clean areas for viable microorganisms and non-viable particles, together with parameters such as pressure differentials, to confirm that each area stays in its classified state. Japanese EM reports separate airborne viable counts from active air sampling, settle plate counts and surface counts from contact plates or swabs, each with alert and action levels. An excursion is investigated for its impact on product made during that period. The aim is to catch drift early, not only to show that grade limits were met.