For environmental monitoring and sterility applications
Rapid Micro Biosystems, a US provider of rapid, automated, non-destructive detection and enumeration technologies in microbiology, is to introduce the next generation of Growth Direct applications in 2013.
The tests, based on the detection of natural auto-fluorescence of micro-organisms, are for environmental monitoring and sterility applications in pharmaceutical quality control laboratories. They do not require any 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. It provides two results in one: positive results in hours, with continued incubation for final results in half the time of the compendial method.
The system also has the capacity to handle high numbers of samples each day. It offers automated reading of all environmental monitoring tests and data transfer to laboratory information systems (LIMS), thereby freeing resources for higher value activities.
The test is non-destructive, allowing for microbial identification.
Rapid Micro Biosystems also offers Growth Direct for sterility, which is said to revolutionise pharmaceutical microbial quality control testing while adhering to the stringent regulatory requirements of sterility testing.
Features include positive results in hours, with early, real-time detection of microbial contamination, allowing for faster response to contamination events. Again, it is a non-destructive test, which means samples with positive results can continue to grow for additional analysis of the micro-organism colony.
The sterility system also offers closed-loop sample prep and provides final results in about 7 days, compared with 14 days for a typical sterility test.
An actual colony count (in colony forming units) is provided at the end of the test, with regular count updates throughout the test.
Rapid Micro Biosystems says these new applications will build on the 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 analyse and enumerate any growing colonies automatically.
User configurable software allows for the creation of alerts on out-of-specification samples, with reporting in colony forming units (CFUs).
“These new applications for automated, rapid sterility and environmental monitoring testing address critical microbial quality control testing needs in pharmaceutical manufacturing,” said Steve Delity, president and ceo of Rapid Micro Biosystems.
“Businesses will be able to react quickly to contamination events while increasing productivity and standardising their QC processes.”
The new systems and applications will be available in the first half of 2013.