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.
Retaining the accuracy and reliability of the compendial sterility test, Growth Direct™ System for Sterility provides detection of aerobic and anaerobic contamination starting within hours instead of waiting 14 days with the traditional sterility test.
The sample preparation method mimics the current testing using the same pumps in either an isolator or biological safety cabinet.
The device provides early detection of a positive microbial contamination allowing faster response to contamination events.
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.
Colonies grow on the surface of the membrane and can be "picked" directly, eliminating the time and labor necessary with a subculture step
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.
No additional reagents are added. Samples with positive results can continue to grow.
The system alerts users immediately via email when samples are out of conformance.