BIOTRAK REAL-TIME VIABLE PARTICLE COUNTER
A game-changer in pharmaceutical manufacturing environments. An advanced Alternative & Rapid Microbial Method (ARMM) with regulatory approval. Supports compliance with key continuous sampling directives in EU GMP Annex 1 (2022). Immediately deployable as a root cause investigation tool. This biofluorescent particle counter provides real-time counts of total and viable particles in pharmaceutical manufacturing to reduce aseptic interventions, improve root-cause investigations, and increase process knowledge in fully automated continuous microbial monitoring applications.
See our white papers, industry features, and application notes.
The BioTrak™ Real-Time Viable Particle Counter provides real-time counts of total and viable particles. Using proven laser-induced fluorescence (LIF), it is one of the most advanced real-time continuous microbial monitoring systems for aseptic manufacturing applications and the optimum tool for rapid deployment in root cause investigations and analysis.
Put the Pharma 4.0-ready BioTrak at the centre of your Contamination Control Strategy to safeguard Grade A and other critical environments and increase your process knowledge.
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)
Learn More
White papers
Major industry publication features
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- A Discussion on Bio-fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
Source: PDA Journal of Pharmaceutical Science and Technology - Real-Time Viable Particle Monitoring: How Does It Work? How Can It Help?
Source: Pharmaceutical Online - How-To Guide For Mold Investigations Using Biofluorescent Particle Counting Systems
- A Discussion on Bio-fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
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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