Airborne microbial BioAerosol monitoring system supports EU GMP Annex 1 requirements
Cleanroom microbiology specialist, Cherwell has introduced the new MicronView BioAerosol Monitoring System (BAMS) which enables the rapid real-time, continuous monitoring of airborne microbes to support EU GMP Annex 1 requirements.
BAMS is the first truly portable real-time microbial monitor available provides value in continuous monitoring, real-time feedback, and trending in sterile medicinal product manufacturing environments. The certified ISO particle detector uses laser induced fluorescence to detect Active Fluorescent Units (AFU) and count viable microbes without need for culturing. The introduction of the BAMS rapid microbial monitoring (RMM) system means Cherwell now offers a complete environmental monitoring (EM) portfolio to meet all cleanroom microbiology needs.
According to Emma Millburn of Cherwell, adding the MicronView BAMS to the company’s products means that it can offer an RMM option to its clients if they feel it is appropriate for their particular EM needs.
“With BAMS, which can enable early detection applications, sitting alongside our other viable microbial detection and identification products, this means that we cover all the requirements for cleanroom microbiology EM,” she says.
As a new RMM technology, it can provide a complementary tool to traditional culture-based methods. Lightweight at just 5.8 Kg with a large touchscreen useable with latex gloves, BAMS can be easily used in many critical locations to deliver continuous, real-time results without need for staining or reagents for up to 6 hours while on battery power.
The use of Biofluorescent Particle Counters to support continuous monitoring, real-time feedback and trending is growing rapidly and these instruments have the potential to improve process understanding in the most critical manufacturing environments.
The BAMS product sits alongside other cleanroom microbiology products from Cherwell, including the Redipor prepared media range, comprising agar plates, bottled media, broth bags, vials and ampoules, and SAS microbial air samplers, supporting both passive and active EM applications, plus microbial identification.
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