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26th September 2023  Content supplied by: Merck

Automated Detection System for Early Detection of Microbial Contamination in Filtrable Samples

For decades, the original Milliflex® Rapid system helped QC labs to substantially reduce the time-to-result of sterility and bioburden testing. The growing need in the pharmaceutical industry for proven rapid microbial detection systems has now persuaded us to reintroduce an updated version of it. The Milliflex® Rapid 2.0 system is equipped with a range of new features but is still based on the same proven adenosine triphosphate (ATP) bioluminescence technology and offers the same performance.

Earlier results save time and costs.
The ideal solution for rapid bioburden and sterility testing, the Milliflex® Rapid System 2.0 automatically detects, images, and quantifies viable microbial contaminants in filterable samples throughout the manufacturing process. It's up to 4x earlier results help to improve process control, product yield, and the timely release of final products. In case of contamination, corrective action can be taken earlier, so less time, money, and production capacity are lost.

A wide variety of samples

The system’s growth-based method combines membrane filtration and ATP bioluminescence technology to detect micro-colonies at a sensitivity of 1 CFU. It is possible to detect Gram-positive and negative bacteria, anaerobes, yeasts, and molds in a variety of filterable samples that occur in the pharmaceutical, ATMP, biotech, and personal care industries, including:

  • Raw materials
  • Sterile and non-sterile final products
  • Water-based samples
  • Cell-based samples

Proven rapid for a 5-day sterility testing
The Milliflex® Rapid 2.0 System is particularly well-suited for sterility testing, a mandatory release test for all drug products in the pharmaceutical industry purported to be sterile (EP 6.3, chapter 2.6.1, EP 7.0, chapter 5.1.9 / USP chapter 71). The traditional sterility test requires an incubation time of at least 14 days to get the final result. By changing the traditional test approach from liquid media incubation to solid nutrient media, and the detection from visual inspection to an automated bioluminescence assay, the Milliflex® Rapid System 2.0 reduces the time-to-result substantially down to 5 days.

The Milliflex® Rapid Sterility Test has been evaluated by the FDA’s Center for Biologics Evaluation and Research (CBER) as a faster sterility test to identify microbial contamination in biologicals and has been successfully validated and implemented by different pharmaceutical companies.

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Date Published: 26th September 2023

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