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Sterility Testing Consumables, Media & Instruments

Sterility testing is an essential part of validation for products manufactured according to GMP purporting to be sterile. False negative results could lead to the release of contaminated products, whereas false positives could give rise to lengthy and costly investigations. Have confidence in your sterility test results with our extensive portfolio of Quality control solutions that you can rely on for regulatory compliance e.g. with USP, the European Pharmacopoeia and the Japanese Pharmacopoeia. 


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Steritest® System for Sterility Testing

Configure your Steritest® system to fit your sample, packaging, and controlled testing environment needs.

Our portfolio, which offers a fully regulatory compliant testing workflow (USP <71>, EU Pharmacopoeia < 2.6.1> and JP Pharmacopoeia <4.06>) includes:

  • Sterility testing pumps and accessories
  • Membrane filtration devices
  • Culture media, rinse fluids and solvent
  • Direct inoculation method

M-Trace® Electronic Test Record Software & Mobile App for Sterility Testing

By giving step-by-step guidance and recording data automatically in real time, the M-Trace® system offers a convenient and reliable way to comply with regulatory requirements regarding traceability and data integrity. During each sterility test, the M-Trace® software gives step-by-step handling instructions, either on the pump’s display or by voice, while capturing all relevant test data in real time. 

MILLIFLEX® RAPID SYSTEM FOR RAPID STERILITY TESTING

The Milliflex® Rapid System 2.0 is an automated solution for the rapid detection, imaging, and quantification of viable microbial contaminants in filterable samples throughout the manufacturing process. Its state-of-the-art ATP-based technology and highly sensitive detection camera, allow the Milliflex® Rapid System 2.0 to deliver sterility results in 5 days instead of the traditional 14 days resulting in faster corrective actions in case of contamination.


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