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An air impaction microbial assessment of your air supply may indicate you have unwanted inhabitants in your compressed air system
RUDY PINA
INTRODUCTION
Manufacturers of medical devices who label their product as sterile may use compressed air in various applications. Applications include injection molding, operation of conveyor belts, and/or aseptic cleaning processes. The manufacturer may use these systems on a continuous basis or on an as-needed basis. The manufacturer may not realize that the compressed air system could be harboring microorganisms.
When the air supply system is operating, it may unleash contaminants which could adversely affect the product, including operational characteristics, by compromising sterile claims, or product aesthetics.
The condition or the quality of the supplied air, from a microbiological standpoint, may not be obvious unless microbiological testing is performed. A simple air impaction microbial assay of compressed air lines, however, will alert the manufacturer to the various types of viable microorganisms that might be present.
Manufacturers of medical devices, pharmaceutical operations, or those classified as sterile fill, are constantly assessing the environmental impact on the product during the manufacturing process. This assessment usually includes the facility, the equipment, and the personnel involved in the assembly process. Sampling may include, but is not limited to, surface sampling, particulate counts, water analysis, and product testing. However, compressed air can easily be overlooked if not initially inserted into the environmental monitoring protocol or identified by an experienced environmental scientist.
The engineering department may design the facility whereby the air compressor is segregated from the area where the product is assembled for logical hygienic
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