The Milliflex® Rapid System for Rapid Sterility Testing

Three times as fast

With the Milliflex® Rapid System for Rapid Sterility Testing, you can detect microbial contamination in a third of the time of your current method 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 an automated bioluminescence assay, the Milliflex® Rapid Microbiology Detection System substantially reduces time to result to only 5 days.

Three proven technologies

The Milliflex® Rapid System for Rapid Sterility Testing uses proven technologies including membrane filtration, ATP bioluminescence and image analysis.

• Membrane filtration - Today’s standard for sample preparation. Large volumes of products may be processed and any inhibitor substances can be easily rinsed away.
  
• ATP bioluminescence - ATP (adenosine triphosphate) is a proven indicator of cell viability.
  
• Image analysis for enumeration of microorganisms - The concentration of ATP required for measurement is about 200 attomoles. This is equivalent to one yeast or mold cell, or approximately 100 bacterial cells, depending on their metabolic state. Due to the sensitivity of the reagents, combined with a charged coupled device (CCD) camera and image processor, a much shorter incubation period is required to generate sufficient ATP for detection and enumeration.

The system amplifies the light emitted by the microorganisms on the membrane thousands of times, and captures the signal with a CCD camera. The image analysis software enumerates the microorganisms and displays them on a computer screen.

Automated image analysis

The detection tower scans and develops an image of the microcolonies on the membrane. The technologically advanced Milliflex® Rapid Image Analysis software enables analysts to test sterile products in a third of the time of compendial methods.

The system counts each microcolony and stores the data for downloading, printing and retrieval. In less than two minutes, the sample analysis and results are displayed, along with the batch history and an electronic image of the membrane. Results are shown in familiar colony forming units (CFUs), which can also be viewed three dimensionally. The batch history allows analysts to identify trends at a glance, and the electronic images confirm test results.

21 CFR Part 11 compliance ready

The Milliflex® Rapid Microbiology Detection and Enumeration software meets the requirements of FDA Regulation 21 CFR Part 11 for Electronic Records and Electronic Signatures. The software’s powerful batch reporting feature includes capabilities for electronic signing, performing audit trails, and preventing the alteration of data files.

Access and editorial privileges are controlled via the software administrator module, ensuring secure data acquisition and audit trails conforming to 21 CFR Part 11.

Application of bioluminescent reagents onto membranes

The Milliflex® Rapid AutoSpray Station automatically applies the two reagents across the membrane surface in order to reveal the ATP present in all living microorganisms.

Consistent, reproducible performance

Using a validated, pre-set automated program, the AutoSpray Station secures reproducible reagent application. The calibrated glass nebulizers and pinch valves ensure that the volume of reagent dispensed during each cycle is constant. An internal compressor allows stand-alone operation, eliminating the need for additional equipment or pressure line connection.

Streamlined operation

In automatic spray mode, the AutoSpray Station dispenses both reagents in 90 seconds at the touch of a button.

Easy to clean and maintain

The AutoSpray Station displays warning messages when calibration, cleaning or priming are required, ensuring consistent and reliable performance throughout the life of the system. The system should be recalibrated after every 5000 samples, or at least once a year. On-site maintenance services are available to ensure the reliability of the system.

Validation support

Comprehensive protocols are available to make validation faster and easier. The validation protocol book contains ready-to-use installation, operation, and performance qualification protocols that are written to the same standards as the protocols used to validate pharmaceutical processes.