Milliflex^® Rapid System 2.0

An Automated System for Rapid, Accurate Detection and Enumeration of Microorganisms

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 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, avoiding loss of time, money, and production capacity.

Based on adenosine triphosphate (ATP) bioluminescence technology, the Milliflex^® Rapid System 2.0 delivers faster test results than traditional microbial contamination detection methods, such as membrane filtration and pour plates. Best used in combination with Milliflex Oasis^® sample preparation and filtration, the Milliflex^® Rapid System 2.0 achieves highly consistent and reliable results. It can clearly distinguish between mixed microbial growth of slow-growing and fast-growing microorganisms, variances in colony size and ATP content in filtrable samples.

Rapid Sterility Testing at Three Times the Speed

The Milliflex^® Rapid System 2.0 for rapid sterility testing lets you detect microbial contamination in a third of the time your current method needs, and with a sensitivity down to 1 CFU per sample.

Traditional sterility tests require an incubation time of at least 14 days to deliver final results. By changing the testing approach from liquid media incubation to solid nutrient media, and detection from visual inspection to a more sensitive and automated bioluminescence assay, the Milliflex^® Rapid System 2.0 substantially reduces time to result to only 5 days.

Three Proven Technologies

The Milliflex^® 2.0 System is based on three proven technologies, which makes validation easier. These are membrane filtration, ATP bioluminescence and image analysis.

• Membrane filtration - As today’s standard for preparing samples to detect and enumerate microorganisms, membrane filtration allows a large volume of product to be processed, while any inhibitor substances are easily rinsed away.
  
• ATP bioluminescence - Found only in living cells, adenosine triphosphate (ATP) is a proven indicator of cell viability.
  
• Image analysis for enumeration - The ATP concentration required for the recognition of microorganisms is equivalent to one yeast or mold cell or approximately 100 bacterial cells, depending on their metabolic state. The camera’s sensitivity, combined with state-of-the-art image analysis and optimized reagents, requires only a short reagent incubation period to detect enough ATP for the recognition and enumeration of microcolonies.

The system’s CMOS camera captures light signals that the microorganisms on the membrane emit. The image analysis software intensifies the bioluminescence from each cell (or microcolony) thousands of times. An image processor subsequently enumerates the microcolonies and displays them on a computer screen.

Automated Imaging Analysis

The technologically advanced Milliflex^® Rapid Image Analysis Software lets you test samples in a fraction of the time of traditional methods. Access and editorial privileges are controlled by the system administrator, ensuring secure data acquisition and retrieval.
The system counts each microcolony and stores the data for downloading, printing and retrieval. Within only two minutes, a sample is analyzed and the results displayed, along with the batch history. The electronic image of the membrane and any CFUs detected is also displayed. It can be viewed in 2D or 3D.

21 CFR Part 11 Compliance Ready

The Milliflex^® Rapid System 2.0 software meets the requirements of FDA Regulation 21 CFR Part 11 for Electronic Records and Electronic Signatures. The software’s powerful batch reporting feature meets the technological requirements of FDA's 21 CFR Part 11 for Electronic Signatures and Electronic Batch Reporting. The batch reporting feature includes capabilities for electronic signing, performing audit trails, and rendering data files unalterable.

Application of Bioluminescent Reagents onto Membranes

An integral component of the Milliflex^® Rapid System 2.0 to detect living microorganisms, the AutoSpray Station applies precisely the right volumes of the ATP releasing reagent and the bioluminescence reagent across a filter membrane.

Consistent, Reproducible Performance

Using a proven, pre-set automated program, the AutoSpray Station ensures reproducible results, test after test. Reagent application is achieved using a back and forth sweeping movement of the filter holder under the calibrated glass nebulizer.

Pinch valves ensure that the same volume of reagent is dispensed during each cycle. An internal compressor allows stand-alone operation, eliminating the need for additional equipment.

Streamlined Operation

The AutoSpray Station delivers both reagents in 90 seconds at the touch of a button.

Easy to Clean and Maintain

The AutoSpray Station issues a warning message across the control panel when calibration, cleaning or priming is required. This ensures consistent and reliable performance throughout the system's lifetime.

As a self-cleaning unit, the AutoSpray Station is ready for reuse after only five minutes. The unit should be recalibrated after every 5,000 samples, or at least once a year.

Worldwide Regulatory Compliance

ATP bioluminescence technology used by the Milliflex® Rapid system is recognized as an alternative detection method by:

• FDA^1,2
  
• PDA Technical Report No. 33: Evaluation, Validation and Implementation of New Microbiological Testing Methods³

Membrane filtration is a recommended methodology in the capture of microorganisms by worldwide pharmacopoeias (US, European and Japan).

The Milliflex® Rapid system 2.0 is calibrated to International light standard [LNE/NIST] and meets electrical conformity to the CE mark.

¹FDA draft guidance for industry, PAT — A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, September 2004.
²FDA/OPS meeting, April 13, 2004, pages 104–110, 136.
³PDA. May/June 2000. Technical Report No. 33: Evaluation, Validation and Implementation of New Microbiological Testing Methods. PDA Journal of Pharmaceutical Science and Technology 54(3) Supplement TR33.

Support and Services

We provide technical support and comprehensive services to help you save QC resources and facilitate the implementation of your Milliflex^® Rapid System 2.0 and its integration into your daily testing routines. Our highly experienced teams are there to assist you.
To find out more, contact your local sales representative.