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Rapid Sterility Testing with Celsis

The Celsis system for sterility testing is similar to the compendial 14-day method but uses a more sensitive method of detection. Which means it works just as well but much faster. So you'll reduce working capital requirements, shorten production cycle times, free up warehouse space, and get your products to market sooner. Contact Celsis Rapid Detection to get started. In North America call Toll-free: 800 222 8260. Or call our main office for Europe/Asia/Africa in Belgium +32 2 534 08 91.

How is Celsis faster?

ReduceHoldTimeFrom14days

No visual ID needed. And no subjectivity.
Our system doesn’t depend on the typical 14-day growth period needed for visual detection of microbial presence. By using our highly sensitive, proprietary AK-based detection method, we can significantly reduce testing time. Customers are validating Celsis for rapid sterility testing in as few as two days. Others are cutting testing time from 14 to 5 or 6 days. Still another prefers to stay with a 14 day test that, using Celsis, is now equivalent to a traditional test of 28 days. What you choose will depend on the product, its container or batch volume, where the testing occurs in your manufacturing process, and other risk variables. We'll be happy to discuss these with you: just contact us to get the conversation started.
 

Easy to implement, easy to validate, easy to love.

Existing sampling plans, sample sizes, growth media, incubators and incubation temperatures don’t need to change when adopting the Celsis method. This means less training is needed (and less stress is created) during the implementation process.
 
Celsis has an in-house validation lab staff dedicated to helping customers identify and prepare validation and regulatory submissions. That’s in addition to our regulatory compliance manager and two FDA-accepted Drug Master Files (DMF) for our rapid detection assays.
 
With the Celsis system, you can detect microbial presence generations quicker, while also removing subjectivity and potential technician error. The Celsis Rapid Detection system works on the widest range of products – both filterable and non-filterable – including solids like scalpels and stents. Celsis can readily detect microorganisms in opaque products where turbidity is difficult or impossible to assess. And unlike the traditional protocol that requires waiting and subculturing (adding days to your testing time), the AK reaction is not hampered by the color or viscosity of the sample.  

Additional Resources

  • Watch a brief video of Celsis Rapid Sterility Testing (Requires Flash)
  • Download literature on Celsis Rapid Sterility Testing (PDF, 255KB)
  • Scientific poster on implementing rapid sterility, presented at the PDA Annual Meeting, April 2009 (PDF, 99KB)
  • Scientific poster on the use of AK technology for sterility testing, presented at PDA Microbiology, October 2008 (PDF, 287KB)
  • Contact Celsis Rapid Detection with our online form, or call one of our locations

Related Links

Contact Celsis for a demonstration of Rapid Detection Customer Value
Calculate your 5-year net value savings with Celsis Rapid Detection Calculator
Watch the demo on Celsis Rapid Sterility Testing

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