Milliflex® Quantum Rapid Detection System

Dr. Marcel Goverde

Managing Director, MGP Consulting, Switzerland

Milliflex® Quantum was successfully validated as a rapid alternative method to the traditional bioburden testing

An Easy-to-Use, Non-destructive, Fluorescent Staining-based System for Faster Microbial Detection

To monitor product quality effectively, it’s critical to test for microbial contamination throughout the manufacturing process. However, traditional microbiological methods are slow and require several days to obtain test results. In order to keep pace with today’s increasing production demands, you need to reduce the time to result. By doing so, your company will be able to address contamination events sooner, avoid line shutdowns, release product to the market faster, and reduce warehousing costs. The ability to obtain microbiology test results earlier also enables you to gain better control and understanding of your manufacturing process.

Milliflex Quantum Rapid Detection System
  • Non-destructive method enables reliable identification
    using any ID technology
  • Easy-to-use system and simple workflow requires minimal training
  • Results comparable to compendial method, enabling faster validation so that you can benefit from rapid detection sooner
  • Economical, robust system
  • Compact hardware fits on any laboratory bench
Milliflex oasis filtration system for Bioburden testing

We offer the solution you need with the Milliflex® Quantum system: a rapid fluorescent-based technology designed for fast quantitative detection of microorganisms over a broad range of filterable matrices. This easy-to-use and simple system uses industry-standard membrane filtration techniques to detect viable and culturable microorganisms down to
1 CFU per sample. Test results are also comparable to your current microbial test results, which facilitates validation of this rapid system in any laboratory. The non-destructiveness of this method also allows you to identify any microorganisms detected during the initial fluorescent count, using your current ID methodology.

Applications

  • Raw material (media, buffers, pharmaceutical ingredients and water)
  • In-process samples (bioburden prior to sterilization, CIP/SIP samples, cell culture/fermentation samples,
    media for fermentation, buffers for manufacturing, and intermediate process samples)
  • Final product
  • Environmental samples

The Milliflex® Quantum system is based on two proven technologies: membrane filtration and fluorescent staining. The Milliflex® Quantum method utilizes proven Milliflex Oasis® membrane filtration devices for sample preparation, which ensures consistent, reliable results. Large sample volumes can be processed through the Milliflex Oasis® funnel. The unique design ensures all substances that could inhibit microbial growth are rinsed away. After filtration and incubation, reagent is applied to the membrane, staining any retained viable and culturable microorganisms with a fluorescent marker. The reaction requires active microbial metabolism for enzymatic cleavage of a non-fluorescent substrate. Once cleaved inside the cell, the substrate liberates free fluorochrome into the microorganism cytoplasm (Figure 1). As fluorochrome accumulates inside the cells, the signal is naturally amplified. The cells are then exposed to the excitation wavelength of the fluorescent dye in the Milliflex® Quantum reader so that they can be visually counted.

Milliflex® Quantum spot counter software

The Milliflex® Quantum camera combined with the Milliflex® Quantum Spot Counter software makes the sample reading more convenient and allows you to track records for optimized microbiology QC labs. Download the software here.

Streamlined validation of rapid detection methods

The validation process of an alternative method can be long and intensive, which makes changing from a traditional to rapid microbiological technology a common challenge for many companies. This is primarily due to the need to compare rapid and traditional microbiology test results — a process that can be quite complex. In addition, hardware complexity can also increase the difficulty of the validation process.

The Milliflex® Quantum system overcomes these challenges by offering a solution based on minimal change to the compendial tests. Sample preparation and incubation conditions remain identical to traditional microbiology. Results are still based on industry standard membrane filtration and therefore comparable to your current test results.

Discover our complete service offering for the Milliflex® Quantum system.

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