Rapid Micro Biosystems, the provider of rapid, automated, non-destructive detection and enumeration technologies in microbiology, today announced the 2013 availability of the next generation of Growth Direct™ applications. The new system will support environmental monitoring testing, sterility testing, water testing and bioburden testing within the same instrument using the proven detection technology.
With the introduction of the Growth Direct™ system for multiple applications, the Rapid Micro Biosystems product portfolio expands to include 3 instrument systems and 4 specific applications:
The Growth Direct™ System for Environmental Monitoring which automates the high volume testing typically found in the combination of air, surface and personnel monitoring.
The Growth Direct™ System for Sterility which revolutionizes pharmaceutical microbial quality control testing while adhering to the stringent regulatory requirements of sterility testing.
The Growth Direct™ System for multiple applications which supports all the tests above plus product bioburden and water testing on a single device.
These new systems and applications build on the existing Growth Direct™ technology platform currently used in FDA regulated manufacturing facilities. Sample preparation mimics the existing method. Once samples are loaded, the system uses the natural auto-fluorescence of the living cells to automatically detect, analyze and enumerate growing colonies. The test is non-destructive and uses no reagents, ensuring the availability of the sample for identification. User configurable software allows for the creation of alerts on out-of-specification samples, with reporting in colony forming units (CFUs.) The system software is easy to use in modes ranging from totally manual to paperless via the laboratory information system (LIMS.)
"The ability to provide all key microbial tests using a non-destructive, rapid method on a single, automated system will revolutionize quality control in pharmaceutical manufacturing. Businesses will be able to react quickly to contamination events while increasing productivity and standardizing their QC processes," said Steve Delity, President and CEO of Rapid Micro Biosystems.
The new systems and applications will be available in the first half of 2013.