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May 1, 2006

Chementator: Microbial contamination — see it and believe it

In Anaheim, Calif., last month at the Parenteral Drug Assn.’s annual meeting, Pall Corp. (East Hills, N.Y.; introduced Ascotec to the global market, a faster, more accurate system for detecting microbial contamination in clean-room air systems. When compared to Pall’s Ascotec, other monitoring technologies have two disadvantages, says Christopher J. Mach, marketing manager of biotechnology at Pall: they do not readily distinguish between true contamination that is captured from the clean-room air system versus erroneous contamination that is introduced within the monitoring system by an external source such as an operator; and, they impose more physical stress on microorganisms making true contamination harder, if not impossible, to detect.

Operating at a low velocity of 11 L/s, compared to 50 L/s in other samplers, Ascotec’s BioCapt impactor sampling technology maintains a high collection efficiency while avoiding severe stress to microorganisms. “With less stress to the organisms, it is possible to achieve faster microbial growth,” says Mach. This means faster contamination detection.

Meanwhile, an array of precise rectangular slits (photo), exactly 90 µm wide, allows interception of microorganisms that would normally lack sufficient sedimentation speed and would therefore escape observation. The slit arrangement limits the deposit of microorganisms to a recognizable pattern on the assay media surface. As a result, random contamination that is present outside the controlled impact region can be easily distinguished.

Ascotec is available as either a remote or portable system. The remote version accommodates simultaneous or sequential sampling of up to sixteen independent lines, while alternative systems can handle ten at most, says Mach. In addition to clean-room air monitoring, the portable system can be used in compressed-gas systems and isolators.

Previously available in the Italian market, Ascotec’s worldwide launch included presentation at this month’s Achema show and coincides with its unique ISO 14698 approval. Other relevant regulatory approvals include U.S. 21CFR Part 11 and Good Manufacturing Practices.

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