ABSTRACT
In order to confirm that biocontamination controls are operating properly, it is necessary to assess the microbial levels of the air and surfaces of cleanrooms and controlled environments. In this context, biocontamination controls mean every action that is directed toward the detection, reduction, or elimination of microbiological contamination in cleanrooms and other controlled environments. That environment includes the air that ventilates the facility, the surfaces of the facility (walls, floors, ceilings, tabletops), the equipment, instruments and other hardware therein, and the personnel who occupy the facility. In-house cleaning materials and implements should not escape periodic testing. In addition, in a manufacturing setting, microbial levels should also be determined and controlled for raw materials, process water and the system that produces, stores and distributes it, gases, packaging, and final products.
