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BIOTRAK®

BIOTRAK®

BIOTRAK®

Product catalog summary
Overview: The BioTrak® Real-Time Viable Particle Counter Model 9510-BD is a sophisticated instrument designed for real-time detection of airborne viable particles. It integrates patented laser-induced fluorescence technology for particle viability detection and offers comprehensive features for particulate analysis.
Key Features and Benefits:
  • Detects particles ranging from 0.5 to 25 µm with up to six channels for simultaneous total and viable particle data.
  • Incorporates a patented laser-induced fluorescence viability detection system.
  • Complies with ISO 21501-4 standards and offers a sample flow rate of 1.0 CFM (28.3 L/min).
  • Features an intuitive touch screen interface and supports recipe-based sampling protocols.
  • Provides reports compliant with ISO-14644-1, EU GMP Annex 1, and FS209E.
  • Offers Ethernet and USB outputs for data transfer and can operate stand-alone or integrate into facility monitoring systems.
Specifications:
  • Particle size range: 0.5 to 25 μm with channel sizes at 0.5, 0.7, 1.0, 3.0, 5.0, and 10 μm.
  • Counting efficiency: 50% at 0.5 μm and 100% for particles >0.75 μm.
  • Flow rate: 1.0 CFM with ±5% accuracy.
  • Calibration: NIST traceable, recommended annually.
  • Hardware includes a 660 nm laser diode for total particulate and a 405 nm laser diode for viable particulate detection.
  • Dimensions: 19 in. x 10.5 in. x 11.7 in. (48.3 cm x 26.7 cm x 29.7 cm), weight: 37 lbs (16.8 kg).
Operational Capabilities:
  • Real-time detection allows immediate contamination alerts and supports process improvement and risk management.
  • Supports manual and automatic sampling modes with a wide range of sampling times and frequencies.
  • Data storage capacity for 10,000 sample records across 999 locations.
  • Programmable alarm limits and built-in audible alarms for user-defined conditions.
Accessories and Software:
  • Includes essential accessories like power supply, isokinetic probe, and calibration certificate.
  • Optional accessories include electronic filter scanning probes and aerosol generators.
  • Software includes TrakPro™ Lite Secure and optional FMS Software for enhanced data management.
Environmental and User Interface:
  • Operates within 41° to 86°F (5° to 30°C) and 20% to 85% RH non-condensing.
  • Features a VGA 5.7-in. touch screen display and supports multiple languages.
  • Security features include two-level password protection.
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Catalog excerpts

BIOTRAK®-1

BioTrak® Real-Time Viable Particle Counter Model 9510-BD Confidence comes with a higher caliber of data BioTrak® Real-Time Viable Particle Counter offers bestin-class features and versatility in the exciting new field of real-time airborne viable particle detection— detecting total and viable particle counts in real time. It incorporates TSI® field-proven, patented laser induced fluorescence (LIF) technology to determine particle viability. The TSI® BioTrak® Real-Time Viable Particle Counter combines real-time viable particle detection, total particulate detection, and integrated particle collection functionality into a single portable instrument. Real-time viable particle detection enables: ▪ Immediate notification of contamination events allowing ▪ egregation of product potentially exposed S to contamination ▪ Initiation of root cause investigations ▪ Initiation of control measures ▪ Trending of biological particulate levels ▪ Information for process improvement (PAT) ▪ Information for process risk management (ICH Q9) ▪ Feedback for gowning and aseptic process training Features and Benefits ▪ Particulate size range: 0.5 to 25 µm ▪ p to six channels of simultaneous total and viable U particle data ▪ Patented laser induced fluorescence viability detection ▪ ntegrated particle collection filter for offline I speciation analysis ▪ Complies with all requirements of ISO 21501-4 ▪ 1.0 CFM (28.3 L/min) sample flow rate ▪ Full optical particle counter functionality ▪ Intuitive icon-driven touch screen graphical user interface ▪ Recipe-based storage and recall of sampling protocols ▪ Reports for ISO-14644-1, EU GMP Annex 1, and FS209E ▪ 10,000 sample record storage, 999 locations ▪ Ethernet and USB outputs ▪ tand-alone operation or integrate into a facility S monitoring system ▪ Displays up to three en

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BIOTRAK®-2

BioTrak® Real-Time Viable Particle Counter Model 9510-BD Particle Counting Size Range 0.5 to 25 μm Particle Channel Sizes 0.5, 0.7, 1.0, 3.0, 5.0, 10 μm Size Resolution <15% @ 0.5 μm (per ISO 21501-4) Total Particulate Counting Efficiency 50% at 0.5 μm; 100% for particles >0.75 μm, (per ISO 21501-4 and JIS) Viable Detection fluorescent channels and 1 sizing 2 channel for discrimination Sample Collection Integrated filter holder for 37-mm diameter filters Concentration Limit 820,000 particles/ft3 (29,000,000/m3) @ 10% coincidence loss Zero Count count per 5 minutes <1 (per ISO 21501-4 and JIS...

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