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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.
A Steritest NEO Membrane Filtration System. This system consists of a filtration unit with two connected chambers filled with a yellowish liquid. The left chamber has a red clamp, and the right chamber has a blue clamp; both are mounted on stands. A needle attached to additional tubing is also present.
A collection of laboratory bottles containing various sterility testing culture media rinse and fluid. There are large transparent bottles with blue labels in the back row, medium-sized transparent and amber-colored bottles with different colored caps in the middle, and small transparent bottles with red, green, yellow, and blue caps in the front row. Each bottle has a label indicating its contents or purpose within sterility testing procedures.
A Sterility Testing Peristaltic Pump. It has a modern design with a digital display screen on the top. The main body of the pump is silver and black with blue accents around the control panel. Attached to the pump are two transparent tubes leading to a metal probe and a plastic component. The background is white.
A Steritest Symbio pump system used for sterility testing in a laboratory setting. The main focus is a handheld device with a digital screen, and several buttons below the screen. This device is connected by a blue tube to the main pump system, which has various ports. In the bbackground, there are various laboratory items. The emphasis on the handheld device suggests it’s an important part of maintenance or monitoring the Steritest Symbio system.
Three pieces of laboratory equipment associated with the Milliflex® Rapid system 2.0. On the left, there’s a stainless steel device with two circular platforms, each holding a clear petri dish with a red medium inside, and several additional petri dishes stacked beside it. In the center, there’s a larger blue device featuring a digital display screen and control buttons; it appears to be an incubator or analyzer with an open door revealing internal components. On the right side of the image stands a white device.
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
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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.

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.

M-Trace® Software for Sterility Testing

Our M-Trace® digital solution enables full traceability and regulatory compliance of your Sterility Test data.

Related Resources

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Related Videos

Slide 1 of 4
Video: Steritest<sup>®</sup> NEO Device
Video: Steritest® NEO Device
Steritest® NEO devices created to improve your workflow safety, reliability and convenience.
Video: M-Trace<sup>®</sup> Software & Mobile App
Video: M-Trace® Software & Mobile App
Your 21 CFR Part 11 compliant Digital QC companion for Sterility Testing, for trusted and efficient data traceability.
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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