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