Rapid sterility test system

The PROMILITE® M4A is a compact and automated instrument ideal for performing large number of tests using ATP Bioluminescence Testing technology for rapid sterility testing.
The instrument is highly sensitive, has two or three injectors and is operated by dedicated PROSCREEN® software. Up to 96 samples in microplate format are processed in a single run within minutes. Simply insert the microplate, press run and walk away.
The reagent additions and data analysis are completely automated. Further automation can be achieved by integrating the PROMILITE® M4A with the PROMICOL’s robotic sampling system.

  • PROMICOL’s, growth based Rapid Sterility Testing technology reduced sterility testing time to 48-72 hours instead of traditional 14 days. Rapid sterility is alternative test method to USP 71, EP 2.6.1 and JP 4.06 sterility tests which allows for shorter incubation periods and faster results.
  • Microbial contamination detection based on the presence of microbial Adenosine Triphosphate (ATP) in a sample. ATP-bioluminescence is a global FDA & EMA approved and well-established method.
  • PROMICOL’s Solution fits for both the methods: Filterable Samples (Membrane Filtration Sterility Testing) and Non Filterable Samples (Direct Transfer Sterility Testing).
  • Faster release of drug product.
  • Implementing Corrective action sooner if the product does not meet specifications.
  • Allows for microbial ID to support OOS investigations.

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