TSI BioTrak Real-Time Viable Particle Counter

Description of TSI BioTrak

ioTrak™ 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
  • Segregation of product potentially exposed 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
• Up to six channels of simultaneous total and viable particle data
• Patented laser induced fluorescence viability detection
• Integrated particle collection filter for offline 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
  • Stand-alone operation or integrate into a facility monitoring system
  • Displays up to three environmental parameters
  • Stainless steel enclosure

Technical specifications of TSI BioTrak

Particle Counting

• 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: 2 fluorescent channels and 1 sizing 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: <1 count per 5 minutes (per ISO 21501-4 and JIS B9921)
• Flow Rate: 1.0 CFM (28.3 L/min) ±5% accuracy (meets ISO 21501-4 and JIS B9921)
• Calibration: NIST traceable using TSI® calibration system
• Calibration Frequency: Recommended minimum of once per year (twice per year for fluorescence)
• Standards: ISO 21501-4, CE, JIS B9921

Hardware

• Total Particulate Light Source: 660 nm laser diode for MIE particle sizing
• Viable Particulate Light Source: 405 nm laser diode for laser induced fluorescence viability detection
• Flow Rate Control: Electronic, automatic closed loop (patented* flow control technology)
• Audible Alarm: Built-in; >85 dB at 1 meter (adjustable)
• External Alarm Relay: Normally open contact closure rated for 0 to 60 V AC/DC at 1.5A peak, 0.5A continuous. Alarm output rated for 60 V insulation. Relay contact closes under user configurable alarm conditions.
• Exhaust: Internal HEPA filter
• Vacuum Source: Internal pump
• Alarm Output: Dry contacts, closed when alarm is engaged
• Display: VGA 5.7-in. (14.5-cm) touch screen display
• Dimension (H x W x D): 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)
• Power: 110 to 240 VAC universal power supply
• Operating Range 41° to 86°F (5° to 30°C),** 20% to 85% RH non-condensing***
• Operating Elevation: 0 to 10,000 ft (0 to 3,000 m)
• Storage Range: 32° to 122°F (0° to 50°C), up to 98% RH non-condensing
• Housing: Stainless steel
• External Chemical Resistance Isopropyl alcohol, chlorinated solution, hydrogen peroxide
• Environmental Sensor Interface: Supports TSI® air velocity, temperature and relative humidity probes

User Interface and Communication

• Sampling Modes: Manual, automatic, beep; cumulative/differential; count or concentration
• Sampling Time: 1 second to 99 hours
• Sampling Frequency: 1 to 9,999 cycles or continuous
• Data Storage : 250 Zones, 999 Locations, 10,000 sample records
• Status Indicators: Flow, Instrument
• Alarm Limits: Programmable for all particle channels (both total and viable)
• Languages: English, German, French, Spanish, Japanese, Chinese (simplified), Italian
• Software Included:
  • TrakPro™ Lite Secure Software
  •  FMS Software (OPC UA Bridge 5SP)
    Optional:
  • FMS Software (full version)
• Unit ID: Configurable IP address
• Security: 2-level password protection to lock out usage and configuration
• Reports: Provides Pass/Fail on ISO 14644-1, EU GMP, and FS209E reports
• Communication Mode:
  • Manual data transfer:
    • Export .xml file to USB drive
    • To TrakPro™ Lite Secure over Ethernet or USB
  • Automatic data transfer:
    • To FMS over ethernet
    • To external software via FMS with OPC UA

Accessories

• Included: Accessories Printed QuickStart guide, power supply, isokinetic probe, tubing, 1/2” barb inlet adapter, zero count filter, USB cable, gelatin filter holder, gelatin filters, cleaning swabs, calibration certificate, and insert card with instructions on how to download manuals and software
• OptionalAccessories: Electronic filter scanning probe, basic filter scanning probe, BioTrak™ aerosol generator, TSI velocity probes, temp/RH probe, isokinetic probes, sample tubing, and hard-sided carrying case

*The BioTrak™ 9510-BD incorporates the following patented technologies: Patent Numbers 6,167,107; 5,701,012; 5,895,922; 6,831,279; 7,261,007.
**Maximum temperature limited by gel collection filter.
***See TSI Application Note CC-104 for operation above 50% RH.
****Size setting at 0.5 and 5.0 µm per ISO 21501-4.