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. Air collection 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.
BioLaz® Real-Time Microbial MonitorThe BioLaz Real-Time Microbial Monitor provides real-time detection of biological organisms in controlled environments used for the manufacture of sterile products. The sensor can be connected directly to Pharmaceutical Net, FacilitySight™, or your own software, and is designed to operate unattended for continuous operation. The BioLaz has been independently tested to meet the rigorous requirements of USP <1223> Validation of Alternative Microbiological Methods and of EP 5.1.6 Alternative Methods for Control of Microbiological Quality, for the Pharmaceutical market. |
MiniCapt™ Portable Microbial Air SamplerThe 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. |
Air Trace® Environmental Slit-to-Agar SamplerThe 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. |
BioCapt™ Impactor Active Microbial Air Sampling AtriumThe BioCapt™ Impactor Active Microbial Air Sampling Atrium enables dedicated, efficient microbiological monitoring of sterile environments. This stainless steel air sampling device can be used alone or in conjunction with the AirCapt™ or MiniCapt™. |
Information on this website is subject to change without notice.