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Abstract:  Over the last century, the concept and use of the cleanroom have continually evolved to provide an increasingly restricted environment with a low burden of contaminants (especially those that are airborne). Although no cleanroom in active use can be kept sterile, the particulate burden circulated via airflow and deposited on surfaces in such areas must be reduced to levels considered acceptable, especially when sterile compounding is performed. In this article on cleanroom cleanliness, pivotal events in cleanroom development are briefly reviewed, contamination control in the sterile-compounding environment is discussed, factors that affect levels of contamination in cleanroom suites are examined, and suggestions for contamination prevention are presented.

Related Keywords: Kyle Mulder, NSF, CETA SCF, NEBB CPT CP, cleanroom, contamination control, particulate burden, airflow patterns, sterile compounding, aseptic preparations, airborne contaminants, work surface contamination, high-efficiency particulate air filtration, HEPA filters, United States Pharmacopeia Chapter <797>, USP, personnel training, air cleanliness, air quality, air changes per hour, air-exhaust vents, cleanroom surfaces, equipment

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