Rapid Sterility Testing


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
Milliflex® Rapid System


The Milliflex® Rapid System

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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.
 
 
Milliflex® Rapid System

Data Sheet
Milliflex® Rapid
System


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Milliflex® Rapid Auto Spray Station

Data Sheet
Milliflex® Rapid Auto
Spray Station


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Events

X 15
15.10.18 - 16.10.18
13th Annual PDA Global Conference on Pharmaceutical Microbiology
Bethesda North Marriott Hotel & Conference Center
Bethsda, MD, USA
20181015