Rapid Micro Biosystems, Inc. Growth Direct™ System
One Oak Park Drive
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Rapid Micro Biosystems provides innovative products for faster detection of microbial contamination in the manufacture of pharmaceutical, biotechnology, and personal care products. The Growth Direct™ System detects contamination earlier, delivering compelling economic benefits to manufacturers, while improving their quality process. The Growth Direct System is the first and only automated system that addresses all key microbial QC applications and fits with current regulatory practices, a critical accelerator for adoption. Automated analysis eliminates error-prone manual steps and saves labor; rapidly detecting contamination enables manufacturers to reduce inventory carrying costs, shorten manufacturing cycle time, and reduce product losses, delivering significant cost savings and increased operational efficiency.
The Growth Direct System uses proprietary digital imaging technology that automatically enumerates microcolonies days earlier than the traditional visual plate counting methods. The system captures the native fluorescence (autofluorescence) that is emitted by all living cells. By detecting microcolonies composed of a small number of cells, the Growth Direct test can automatically report the number of microbes in a sample days earlier than the current visual colony counting method.
The sensitivity and efficiency of the test result from imaging microscopic colonies without magnification using large area CCD imaging. Rapid Micro Biosystem's test is accurate and efficient even when the manufacturing sample to be tested contains only a single replicating microbial cell. Because the detection is non-destructive, the system is easier to validate and compatible with all current microbe identification methods.
The up-front sample prep for the Growth Direct test is just like that for the current tests. Microbes are applied to membranes and grown on nutrient media - but for this digital imaging method much shorter incubation times are required than for today's visual method.
CLICK HERE or click on the image below to view the video from the Rapid Micro Biosystems video library.
Rapid Micro Biosystems has performed key quality tests of the Growth Direct solution in the following areas::
In addition, proof of concept has been successfully accomplished for:
Rapid Micro Biosystems advanced imaging technology delivers microbial enumeration results days sooner than current culture tests. Our non-destructive test is compatible with all microbial identification systems.
This results in manufacturing cost savings and increased productivity for manufacturers!
Rapid enumeration with the Growth Direct system enables manufacturers to make timely cost saving decisions and reduce inventory carrying expenses by providing results days sooner than the current test method.
Savings derived from faster test turnaround include the following:
The result of using Growth Direct is a projected positive return on investment in as little as one year. The test addresses all major applications in pharmaceutical microbiology including: water, environmental (surface & air), in-process bioburden and final product testing.