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BIOTRAK REAL-TIME VIABLE PARTICLE COUNTER

The BioTrak® Real-Time Viable Particle Counter is one of the most advanced Alternative & Rapid Microbial Method (ARMM) real-time continuous microbial monitoring systems for aseptic manufacturing applications. It is a game-changer in pharmaceutical manufacturing environments that is approved by the FDA and immediately supports compliance with key directives in EU GMP Annex 1 (2022). At the centre of a Contamination Control Strategy, the BioTrak provides real-time counts of total and viable particles to reduce or eliminate aseptic interventions, improve root-cause investigations, and increase process knowledge.

See our white papersindustry features, and application notes.

Features and Benefits

  • FDA-approved as a non-inferior Rapid Microbial Method (RMM)
  • Continuous particle counting and environmental monitoring (EM)
  • Detection of airborne viable particles in real-time
    • Fully automated process – no media or manual processing
  • Simultaneous detection of both total and viable particles
    • Complies with all requirements of ISO 21501-4
    • 1 CFM (28.3 L/min) sample flow rate
    • Only requires a single isokinetic probe at the sample site
  • Instant real-time alerts
  • In-line particle collection filter
  • Can be used as a standalone instrument
  • Can be fully integrated with FMS 5 for automated continuous environmental monitoring
  • Intuitive icon-driven touch screen Graphical User Interface
  • Stainless steel enclosure and HEPA filtered exhaust

Applications

  • Continuous automated monitoring of aseptic environments
  • Continuous automated monitoring in support environments
  • Continuous particle counting: viable and total particles
  • Microbial detection and measurement
  • Improved root cause investigations
  • Fast isolation and neutralisation of contamination sources
  • Rapid room release
  • Risk reduction
  • EU GMP Annex 1 update compliance (Grade A mandated continuous environmental monitoring)

MUST READ INDUSTRY PAPERS

Source: PDA Journal of Pharmaceutical Science and Technology

Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit.
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Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium acnes.
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Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing.
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Practical Applications of Bio-Fluorescent Particle Counting in Environmental Monitoring Investigations.
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Source: BioPhorum

Is it time we revisit regulatory expectation that we obtain microbial identifications when using a non-growth-based monitoring method? – BioPhorum Operations Group
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MUST READ BLOG

Read what TSI Contamination Control expert Mike Dingle is saying about data integrity in particle counting for pharmaceutical manufacturers.

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