4 Benefits of Automation Download
Microbiology and Statistics Presentation
Improve Quality Control

Rapid Sterility Results Starting within Hours

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. 

Covers all Three Compendial Conditions

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Positive Results in Hours

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The device provides early detection of a positive microbial contamination allowing faster response to contamination events.

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.

Discrete Colonies

Colonies grow on the surface of the membrane and can be "picked" directly, eliminating the time and labor necessary with a subculture step

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Closed Loop

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.

Non-Destructive

No additional reagents are added. Samples with positive results can continue to grow.

Actionable Reporting

The system alerts users immediately via email when samples are out of conformance.