Growth Direct™ will cut sterility testing time in half (from 14 to 7 days), provide early detection of a positive microbial contamination for a faster response, reduce the risk of human error, and provide incubation, enumeration, reporting, and integration to your laboratory information management system (LIMS). The result: improved efficiency and productivity.
Growth Direct will streamline pharmaceutical microbial quality control (QC) testing while adhering to the stringent regulatory requirements for sterility testing. With Growth Direct, you will be able to test filterable anaerobic and aerobic samples in high- and low-volume sterility testing environments.
Discrete colonies growing on the surface of the membrane will be able to be "picked" directly, eliminating the time and guesswork necessary with a subculture step.
And Growth Direct is a non-destructive test. No additional reagents will need to be added. Samples with positive results can continue to grow.
Changes to 21 CFR Part 600 and 680 amendments to the Sterility Test Requirements for Biological Products provide manufacturers the flexibility to adopt new methods as they become available.
Rapid sterility methods have already been validated to a standard acceptable to regulatory authorities.
Validation is performed according to USP <71> with growth promotion at <10 colony forming units (CFUs). Growth is measured in the presence of product for specificity and accuracy.
Rapid Micro Biosystems will offer access to a comparability protocol to validate the sterility test. A comparability protocol is a validation strategy and testing document with pre-defined acceptance criteria that is pre-approved by the FDA. Upon completion of the validation testing as defined in the document and passing the defined acceptance criteria, the method is deemed to be approved. The company will then need to send a letter to the FDA confirming the validation has met all the criteria before starting to use the method in routine QC.