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Sterility Testing Consumables, Media & Instruments

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An assortment of sterility testing consumables, media, and instruments. At the center, there’s a sterility testing instrument with a digital screen and attached tubing. Surrounding the instrument are multiple bottles of different sizes containing clear and amber liquids. There are also several petri dishes with colored media in blue, red, and clear hues. To the right side of the image, there’s a rack holding vials with red caps, possibly containing samples or culture media. The background is white.
Membrane Filtration Steritest Testing
Sterility Testing Culture Media & Rinsing Fluids
Sterility Testing Peristaltic Pump
Sterility Testing Services & Maintenanc
Rapid sterility testing method using fluorescence-based detection with Milliflex® Rapid system 2.0

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. 

Products

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
Speak to a specialist

 

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.

Sterility Testing Devices

Minimizing the risk of false positive and false negative results, the Steritest® NEO unit has been proven to be the most reliable filtration device available on the market.

Sterility Testing Culture Media and Fluids

Our sterility testing culture media and rinse fluids are formulated and tested to meet international standards. They provide the highest level of quality and testing confidence.

Sterility Testing Pumps

Our Steritest® Symbio pumps are designed to integrate perfectly into all testing environments. They will speed up and streamline your workflow, maximizing safety, confidence and convenience.

Sterility Testing Accessories

The Steritest® Symbio accessories are designed to facilitate your daily sterility testing work routine. To address your special requirements, accessories are available for a variety of different drug packaging configurations.

Direct Inoculation Method

Sterility testing of non-filterable samples, complying with your different direct inoculation method requirements.

Rapid Sterility Testing Method

The Milliflex® Rapid System 2.0 has been proven to be used for rapid sterility testing by the FDA’s Center for Biologics Evaluation and Research as a faster sterility test to identify microbial contamination in biologicals.

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Related Videos

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Video: Steritest<sup>®</sup> NEO Device
Video: Steritest® NEO Device
Steritest® NEO devices created to improve your workflow safety, reliability and convenience.
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Improve dexterity and reduce risk with the short needle of the new Steritest® NEO devices.
Video: Steritest<sup>®</sup> Symbio Pump
Video: Steritest® Symbio Pump
Designed to integrate perfectly into all testing environments, streamlining your workflow, maximizing safety and convenience.
Video: Sterility Testing Workflow
Video: Sterility Testing Workflow
Steritest® Symbio pumps and accessories are designed to answer the challenges of usage in laminar flow hoods, isolators and cleanrooms.
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