Milliflex® Rapid System 2.0 for 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.
The system's results will 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.
Benefits of Rapid Microbial Detection System
With the Milliflex® Rapid System 2.0 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 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 System 2.0 substantially reduces the time to result to only 5 days.
The Milliflex® Rapid System 2.0 offers significant benefits for microbial contamination testing:
- Consistently fast and reproducible results
- Up to four times faster results than membrane filtration or pour plate methods
- Correlation of CFU counts with those of traditional methods
- Data integrity thanks to 21 CFR Part 11 compliant software
- Easy handling and validation
Milliflex® Rapid System Applications
The Milliflex® Rapid System 2.0 is the perfect rapid solution for bioburden and sterility testing needs. It is compatible with a wide range of filterable samples from the pharmaceutical, beverage, and personal care industries:
- Raw materials
- Sterile and non-sterile final products
- Water samples
- Mineral water and beverages such as iced tea, flavored water, beer, and wine
- Cell-based matrices
Rapid Microbiological Methods with Proven Technologies
The Milliflex® Rapid System 2.0 is based on three proven technologies, which makes validation easier. These are membrane filtration, ATP bioluminescence, and image analysis.
