Validated rapid methods that save time and cost

Traditional sterility testing is effective. But it can be too slow. In the fast-paced world of GMP manufacturing, waiting up to 14 days in some cases for compendial test results can put your timelines, budget, and supply chain at risk.

What you really need are testing methods that can be initiated quickly and allow flexibility for corrective actions early on in the process, that are also compliant, accurate, and ready to handle complex sample types.

The Eurofins BioPharma Product Testing (BPT) network of laboratories’ experts provide complete GMP rapid sterility testing in less time than the compendia method. Utilising several validated technologies, such as the BacT/Alert® 3D system, RedOne™ or Celsis® , we can help you detect contamination early, reduce product cycle times, improve overall production efficiency, all without compromising on quality.

Our technologies

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BacT/Alert® 3D system

Based on colorimetric detection of CO₂ to indicate microbial growth. Accepted as a compendial method for cell-based products.

Group of eight people wearing white lab coats with the Eurofins logo, standing in a laboratory setting. Some individuals wear lanyards with badges, and windows in the background let in natural light

RedOne™ platform

A solid cytometry platform using fluorescence detection. Enables both qualitative and quantitative results.

hree individuals in white lab coats standing in a laboratory. One person is holding a document with a colorful circular pattern on the cover, while the others look at it.

Celsis® platform

Utilises ATP (adenosine thriphosphate) bioluminescence to rapidly detect contamination in a wide range of products.

These rapid systems are validated according to USP <1223> and designed to serve as reliable alternatives to USP <71>.
While not full replacements for compendial sterility testing in all cases, they are suitable for a wide array of applications, particularly where product shelf-life or time-to-market is critical.

Partnering with Eurofins BPT enables you to:

  • Transition smoothly from traditional to rapid methods
  • Validate new methods for regulatory compliance
  • Reduce the operational impact of contamination events
  • Access test results 24/7 via secure online portal
  • Handle a variety of sample types, sizes, and compositions

With rapid sterility testing delivered by experienced microbiologists, Eurofins BPT helps ensure your product remains on schedule and compliant.