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Sterility Testing

NEW in 2024! Growth Direct® Rapid Sterility with Time to Detect in as little as 12 hours and Final Result in as little as 1-3 days.

Growth Direct® Rapid Sterility System

The only fully automated,
non-destructive platform for rapid sterility testing, the Growth Direct® Rapid Sterility System is designed to deliver a TTD (time-to-detect) in as little as 12 hours. Much faster than the traditional method requiring a 14-day endpoint incubation, it also provides final results in as little as 1-3 days. Growth Direct® Rapid Sterility System is a rapid alternative membrane filtration sterility test meeting the harmonized USP <71>, designed to:

  • Enable rapid response to contamination with real-time detection notification
  • Reduce risk by automating traditional processes prone to human error
  • Enhance data integrity avoiding sample handling and data processing errors
  • Maintain test integrity by reducing risk of secondary contamination with a closed-loop design and non-destructive technology

Sterility testing is a critical quality control (QC) step for final release of product. 

The Growth Direct® System overcomes QC challenges with novel growth-based technology that features advanced robotic automation, powerful optical imaging, algorithmic vision analysis, and data management. The result is fast, accurate detection and digitization that can boost productivity in your microbial QC lab while eliminating manual sample analysis and recordkeeping.

Rapid Sterility Testing in a 5-step sample process with a final result in as little as 1-3 days

Accelerated Product Release

By mirroring traditional sterility incubation regimens with a new level of automated efficiency, the Growth Direct® Rapid Sterility System makes it possible to record a negative result in less than half the time – while ensuring data integrity compliance and simplifying operator tasks. So you can release quality products more rapidly, with fewer bottlenecks and less potential waste caused by undetected contamination on the manufacturing line.

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Fewer Steps, Fewer Contamination Risks

sterility kit_feb2024

 

The Growth Direct® Rapid Sterility System replicates all three traditional test conditions within a kit of three cassettes. Simply load the kit and our automated closed-loop system does the rest, running as many as 126 kits at once while reducing risks of secondary contamination. 


Unlike the compendial method, only a single proprietary growth media is needed. And unlike other rapid sterility offerings, the Growth Direct® Rapid Sterility System does not require costly, time-consuming reagents. With our non-destructive technology, in the event of a positive result, organisms are accessible directly from the cassette so that investigation and additional testing can begin immediately.

 

 

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