ABSTRACT

The two principal purposes of an environmental monitoring program are to provide an assessment of the general microbiological cleanliness of an operation and to assess the state of environmental systems control being cognizant of the numbers and kinds of microbes present a microbiologist can assist in the design of an effective control system. The microbiologist’s challenge is further exacerbated by the adoption of arbitrary limits that are imposed by some Food and Drug Administration investigators. The chapter provides a reference point for adopting official or corporate alert/action levels by using a sound scientific rationale. One important component of an environmental surveillance system is the establishment of alert and action levels. However, given that an environmental program is comprehensive, it is dangerous to consider alert/action limits for a single component of the system independently of the other parts of the environmental monitoring system.