Comparative Evaluation of Three Active Air Samplers for the Monitoring of Airborne Microorganisms

Sunday, January 3, 2010

By : Evelyn F.Der, Joe P. Stablein, Daniel A.Coleman,

The evaluation of airborne microorganisms is critical in the biopharmaceutical industry. For manufacturers that produce drugs in an aseptic environment, cleanrooms must meet strict standards. Regulatory requirements such as the US Food and Drug Administration’s Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice and internal corporate policies require monitoring to verify that these standards are maintained. Cleanroom monitoring is dependent upon reliable instruments that are suitable for sampling airborne contaminants in an aseptic environment. These instruments must also be calibratable, portable, and easy to use. In this study, three active air samplers were evaluated for the collection of culturable airborne microorganisms. Bioaerosol collection includes whole microorganisms as well as fragments, toxins, and particulate waste products from all varieties of living things (1).

Materials and methods Air samplers.

The following air samplers were studied: • The “SAS Super 180” sampler (Bioscience International, Rockville, MD) aspirates air at 180 L/min through a solid 304 stainless steel sampling head with 219 precision-drilled holes positioned over the agar at a prescribed distance. After impaction, air exits through an exhaust screen. The unit can accommodate either a standard 55/84-mm contact plate or a 90-mm standard Petri dish below the sampling head. The sampler is fully programmable for features such as time between aspirations, volume of air for each aspiration, and total air volume to be sampled.

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