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A comprehensive environmental monitoring program of clean rooms should include routine monitoring of both viable and non-viable airborne particulates. Although there is no requirement for the microbial identification of all contaminants present in these controlled environments, an environmental control program shall include an appropriate level of bacteria identification obtained from sampling. There are several methods of bacterial identification available.
The first step for correct bacterial identification, especially concerning a clean room isolate, is the Gram staining, since it can provide elucidative clues about the source of the microbial contamination. If microbial identification of isolates reveals Gram-positive cocci, the source of contamination can be derived from humans. If bacteria identification of isolates reveals Gram-positive rods, the source of contamination can be derived from dust or strains resistant to disinfectants. If bacterial identification of isolates reveals Gram-negative rods, the source of contamination can be derived from water or any moistened surface.
Microbial identification in pharmaceutical clean rooms is required for several reasons associated with quality assurance: determination of organisms from the manufacturing environment; bacteria identification from final product testing; demonstrating absence of named organisms from non-sterile products and water; quality control of fermentation stocks in biotechnology; and confirmation of test organisms in validation processes. More and more, the Food and Drug Administration (FDA) is expecting bacterial identification to aid in determining the usual flora for a specific site, to evaluate the effectiveness of cleaning and to troubleshoot the source of contamination that can occur when action levels are exceeded or sterility tests become contaminated.
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