Application Note

BioTrak™ Real-Time Viable Particle Counter: Discrimination Capability

The BIOTRAK Particle Counter is a full-featured instrument that detects the total number of particles in the air as well as determines which of those particles are viable in nature. Additionally, the BIOTRAK Particle Counter incorporates a particle collection filter so the optically analyzed particles are collected and available for subsequent speciation analysis. The BIOTRAK Particle Counter incorporates proven technologies leveraging TSI’s experience in particle measurement theory, instrument development, and calibration.

The BIOTRAK Particle Counter falls into a class of instruments known as Rapid Microbiology Methods (RMM) that have garnered significant interest over the past several years. RMM techniques offer significant potential benefits to manufacturing spaces concerned with environmental microbiological contamination. The key differentiation that the BIOTRAK Particle Counters offer is the ability to detect the presence of viable particles in real time. When compared to the traditional active air sampling and compendial culture based count methods that require 2 to 4 days of incubation and analysis, the BIOTRAK Particle Counter provides:

  • High resolution trending of microbial particle levels in the manufacturing environment
  • Instantaneous notification of microbial contamination events, which enables:
    • Segregation of potentially exposed product
    • Environmental alert and action level alarms
    • Rapid initiation of root cause investigation
  • Process Analytical Technology (PAT) based process control input
  • Potential for real-time product release
  • Real-time feedback to support personnel training on proper clean room practices
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