New applications improve the efficiency of microbial quality control processes while significantly reducing the time-to-result
Bedford, MA (April 16th, 2012) – 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 tests are specifically designed for environmental monitoring and sterility applications in pharmaceutical quality control laboratories. Representing a quantum leap from the current sterility and environmental monitoring test methods, the applications are based on the detection of natural auto-fluorescence of microorganisms. The Growth Direct™ System requires no additional reagents to detect growing colonies.
The Growth Direct™ System for Environmental Monitoring automates the high volume testing typically found in the combination of air, surface and personnel monitoring.
The Growth Direct™ System for Sterility revolutionizes pharmaceutical microbial quality control testing while adhering to the stringent regulatory requirements of sterility testing. Features of the system include the following:
These new applications build on the existing Growth Direct™ technology currently used in FDA regulated manufacturing facilities. As with the Growth Direct™ System for Water and Bioburden, sample preparation mimics the existing method including the ability to integrate to a laboratory information management system (LIMS). Once samples are loaded, the system uses the natural auto-fluorescence of the living cells to automatically analyze and enumerate any growing colonies. User configurable software allows for the creation of alerts on out-of-specification samples, with reporting in colony forming units (CFUs.) The test is non-destructive and uses no reagents, ensuring the availability of the sample for identification.
“These new applications for automated, rapid sterility and environmental monitoring testing address critical microbial quality control testing needs 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.