Get Reliable Results in 5 Days
The Milliflex® Rapid System is an automated solution for rapid, accurate detection of microbial contamination in all filterable samples. Based on the detection of Adenosine Triphosphate (ATP) with a bioluminescence reaction, the Milliflex® Rapid System delivers faster sterility test results than traditional microbial detection methods, which requires 14 days. The Milliflex® Sample Preparation Method also ensures consistent and reliable results. Sterility testing with the Milliflex® Rapid System allows faster release of sterile products to the market and enables earlier implementation of corrective actions, thus avoiding the loss of time and money.
Benefits at a Glance
- Results in 5 days for faster release of sterile products to the market
- Growth based results to detect viable cells and ensure continuity in the interpretation of the test
- Technology compatible with any identification methodology
- Robust and easy to use, it provides consistent and reliable results
- Fully automated data interpretation, independent from the operator
- Compliant with 21 CFR Part 11
Proven Reliability in Rapid Sterility Testing
FDA, Center for Biologics Evaluation and Research (CBER), Rockville (MD) 2010: Identifying faster sterility tests for biological products.
For further references please click here
- PDA Journal of Pharmaceutical Science and Technology / PDA 65/1,42-54 1/2011: Identification of microorganisms after Milliflex® Rapid Detection – A possibility to identify non-sterile findings in the Milliflex® Rapid Sterility Test
- PDA Journal of Pharmaceutical Science and Technology / PDA 64/3,249-63 5/2010: Growth-promoting properties of different solid nutrient media evaluated with stressed and unstressed microorganisms: Pre-study for the validation of a rapid sterility test
- American Pharmaceutical Review, September/October 2010: Introduction of a rapid microbiological method as an alternative to the pharmacopoeial method for the sterility test
- Elsevier Ltd, Vaccines 29 (2011), 8012-8023: Evaluation of growth based rapid microbiological methods for sterility testing of vaccines and other biological products
Watch this video to learn more about the easy operation of the Milliflex® Rapid System for Rapid Sterility Testing.
Easy. Fast. Robust. Milliflex® Rapid System for Rapid Sterility Testing.