TSI AeroTrak™ 9306 Portable Laser Particle Counter

Overview

The TSI AeroTrak™ 9306 Portable Laser Particle Counter is a NIST-traceably calibrated, handheld optical particle counter engineered for real-time airborne particulate monitoring in cleanrooms, controlled environments, HVAC validation, and pharmaceutical manufacturing facilities. Utilizing a high-stability laser diode light source and optimized Mie scattering detection geometry, the instrument measures particle concentrations across six user-selectable size channels within the 0.3–20 µm range. Its 2.83 L/min (1 CFM) volumetric flow rate ensures compatibility with international cleanroom classification standards—including ISO 14644-1, FS-209E, and EU GMP Annex 1—while maintaining rigorous adherence to ISO 21501-4 for optical particle counter performance verification. The device operates on a deterministic counting principle: individual particles passing through the focused laser beam generate scattered light pulses proportional to their cross-sectional area, which are converted into discrete size-resolved counts using a multi-threshold pulse-height analyzer.

Key Features

• True six-channel simultaneous counting with factory-calibrated thresholds at 0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm—fully compliant with ISO 21501-4 calibration traceability requirements
• 3.7-inch color resistive touchscreen running Microsoft Windows® CE OS, enabling intuitive navigation, on-device data review, and real-time concentration display in particles/m³ or particles/ft³
• Integrated dual-mode sampling: manual trigger, programmable timed intervals (1 sec–99 hr), or continuous acquisition (1–9999 cycles); supports cumulative, differential, and alarm-triggered modes
• Onboard HEPA filtration (>99.997% @ 0.3 µm) and precision-matched internal pump with active flow control ensure stable 2.83 L/min delivery regardless of backpressure or ambient conditions
• Embedded acoustic alarm system with configurable thresholds for particle excursions, plus visual indicators for low battery, sensor fault, and flow deviation
• Ruggedized high-impact polymer housing rated for field deployment, IP54-equivalent ingress protection, and ergonomic form factor (25.4 × 11.4 × 7.6 cm; 1.0 kg with battery)

Sample Compatibility & Compliance

The AeroTrak 9306 is validated for use with isokinetic sampling probes (standard included) and optional temperature/humidity sensors (TSI Model 8460), enabling concurrent environmental parameter logging during particle acquisition. It meets the physical and metrological criteria defined in ISO 21501-4 for light-scattering airborne particle counters, including resolution, false count rate, and sizing accuracy tolerances. All calibrations are traceable to NIST Standard Reference Materials (SRMs). For regulated environments, the system supports 21 CFR Part 11 compliance when used with TRAKPRO™ Data Analysis Software (v5.0+), which provides electronic signatures, full audit trails, role-based access control, and secure data export in CSV, PDF, and XML formats. Certificates of Conformance and factory calibration reports are supplied with each unit.

Software & Data Management

TRAKPRO™ Desktop Software serves as the primary data management interface, enabling configuration download, firmware updates, report generation, and statistical analysis (e.g., UCL calculation per ISO 14644-1 Annex D). Raw datasets include timestamp, location ID, channel-specific counts, flow rate, battery status, and operator annotations. Data export supports automated integration into LIMS or MES platforms via ODBC-compliant drivers. Internal memory stores up to 1500 sampling events locally; expanded storage to 10,000 records is managed via embedded flash memory and accessible via USB 2.0 interface. Optional thermal printer (TSI Model 8465) enables immediate hardcopy output of pass/fail reports aligned with ISO 14644-1 classification tables.

Applications

• Cleanroom certification and routine monitoring per ISO 14644-1 Class 1–9 and EU GMP Annex 1 Grade A–D
• HVAC system commissioning, filter integrity testing (including HEPA/ULPA leak scanning support via optional probe accessories)
• Pharmaceutical aseptic processing environment qualification (sterile manufacturing suites, isolators, RABS)
• Medical device packaging validation and controlled assembly area surveillance
• Microelectronics fabrication facility contamination control and tool exhaust monitoring
• Research laboratories requiring portable, standards-compliant aerosol characterization for inhalation toxicology or nanomaterial safety assessment

FAQ

Is the AeroTrak 9306 compliant with ISO 14644-1:2015 for cleanroom certification?
Yes—the instrument’s 0.3 µm lower detection limit, 2.83 L/min flow rate, and six-channel sizing architecture meet all metrological prerequisites for Class 1–9 cleanroom classification under ISO 14644-1:2015 Annex B.
Can the device store and export data in FS-209E format?
Yes—TRAKPRO™ software includes preconfigured FS-209E reporting templates with automatic conversion from particles/m³ to particles/ft³ and statistical confidence calculations.
What is the recommended recalibration interval?
TSI recommends annual recalibration against NIST-traceable reference aerosols; however, users operating in GLP/GMP environments may implement shorter intervals based on risk assessment and internal SOPs.
Does the unit support external environmental sensors?
Yes—optional TSI Model 8460 Temperature/Humidity Probe connects directly to the device’s auxiliary port and synchronizes readings with particle data in both real time and exported reports.
How is data integrity ensured during USB transfer?
All USB transfers utilize CRC-32 checksum validation; TRAKPRO™ enforces write-protection on archived datasets and maintains immutable audit logs of every import/export action per 21 CFR Part 11 requirements.