Microbial Air Samplers
Biological contamination is of special concern to those with aseptic operations. Particle Measuring Systems offers a complete line of microbial air sampling instruments that help manufacturers meet regulatory requirements such as EC-GMP Annex I and FDA Sterile guidelines 2004. Our products are designed to maximize collection efficiency for microbial particles of interest and are validated in accordance with ISO 14698-1. Biological efficiency is guaranteed by ensuring optimal impaction velocity also giving statistical control over false positive results. The impaction heads are fully autoclavable and the instruments can be readily sanitized. All products are compliant with cGMP, GAMP®, and 21 CFR Part 11 regulatory requirements.
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When a full microbial monitoring application is required, the AirCapt MP8 (an integrated PLC controller with SCADA interface and capability of running up to eight remote heads) can be used. This interface fully integrates into standard FMS software and is designed for compatibility with the next generation FacilityNet particle monitoring software. Expansion of the base module allows a second multiple of eight sensor heads to be added to a single PLC controller.
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The MiniCapt portable microbial air sampler allows the user to move the unit around the clean area to collect microbiological particle samples and replicates the Lasair® particle counter range of products in application. There are two accessories: a compressed gas kit for sampling high-pressure process gases and an isolator kit for remote sampling applications.
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The Air Trace® Environmental Sampler uses slit-to-agar technology which provides the ability to predict approximately when the contamination event took place during the sampling process. A remote head and compressed gas kit is available. This is used as the reference method the FDA requires as part of validation.
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The DualCapt Non-Viable Particle Counter & Microbial Air Sampler combines the particle counting ability of the RNet® 510 Particle Counter with the BioCapt® Impactor Head into a single enclosure resulting in a dual-capability microbial and non-viable particle sampling system. This reduces the installation burden many companies see as they migrate to combined system capability.
Information on this website is subject to change without notice.
