Rapid Micro Biosystems, Inc.
The new Growth Direct® Rapid Sterility System includes a novel, proprietary test kit that has been developed to replace traditional methods for product manufacturers required to yield a sterility result prior to final product release. This new system delivers time-to-organism detection in as little as 12 hours and final time-to-result in as little as one to three days. This capability represents a significant improvement over widely used traditional test methods, which generally require a 14-day endpoint incubation, and provides compelling differentiation when compared to current rapid sterility products.
Features, Benefits, and Specifications
The Growth Direct® Rapid Sterility System is a unique automation platform, specific to sterility testing, leveraging the company’s proprietary detection technology, providing customers with all the benefits they are accustomed to with the Growth Direct® System for Bioburden Testing, Environmental Monitoring, and Water Testing applications. Benefits of implementing the only fully automated, non-destructive platform results in enhanced data integrity, reduced human error, and lower hands-on labor costs. In addition, the company expects that the Growth Direct® Rapid Sterility application will enable faster release of final pharmaceutical product, allowing manufacturers to benefit from faster time to market, less potential waste and reduced inventory and holding costs.
Applications
Sterility testing is the final quality check for microbial contamination before a pharmaceutical product is released for commercial sale and is typically performed in a facility that manufactures products such as biologics or sterile injectables.