Available in the 1st half of 2013
The Growth Direct™ System for Sterility revolutionizes pharmaceutical microbial quality control testing while adhering to the stringent regulatory requirements of sterility testing. The technology supports testing of filterable samples for anaerobic and aerobic testing, and is designed for high and low volume sterility testing environments.
Positive Results in Hours
The device provides early detection of a positive microbial contamination
allowing faster response to contamination events.
Sample preparation is closed looped and performed in an isolator or in a clean room, similar to the existing method. The test includes both anaerobic and aerobic test cassettes.
7 Days Versus 14
The Growth Direct™ for Sterility cuts testing time in half. Final results of sterility testing are available in half the time of the current test.
The system provides an actual colony count at the end of the test and provides regular count updates throughout the test.
No additional reagents are added. Samples with positive results can continue to grow for additional analysis of the micro organism colony through a microbial identification system.