TSI AeroTrak Handheld Laser Particle Counter Model 9306

Overview

The TSI AeroTrak Handheld Laser Particle Counter Model 9306 is an ISO 21501-4–compliant portable instrument engineered for high-fidelity airborne particulate monitoring in cleanrooms, controlled environments, pharmaceutical manufacturing facilities, and HVAC validation workflows. It operates on the principle of single-particle light scattering: aerosol-laden air is drawn through a precisely calibrated optical sensing chamber at a constant volumetric flow rate of 2.83 L/min (0.1 CFM), where particles passing through a focused laser beam generate scattered light pulses proportional to their size. These pulses are classified into six user-selectable size channels spanning 0.3 µm to 25 µm—enabling real-time, multi-tiered concentration quantification per cubic meter (or cubic foot). Designed for regulatory-grade environmental monitoring, the Model 9306 delivers traceable measurement integrity through NIST-traceable calibration using monodisperse polystyrene latex (PSL) spheres, validated via TSI’s certified condensation particle counter and aerodynamic classifier infrastructure.

Key Features

• Ergonomic handheld form factor with thumb-actuated controls for reliable one-handed operation during extended sampling sessions.
• 9.1 cm (3.6″) full-color resistive touchscreen display supporting intuitive menu navigation, real-time histogram visualization, and on-device pass/fail assessment against ISO 14644-1, EU GMP Annex 1, and FS209E classification limits.
• Internal memory stores over 10,000 sample records—including timestamp, location ID, channel counts, and environmental metadata—with support for up to 250 predefined sampling locations.
• Integrated dual-mode connectivity: USB 2.0 for local data transfer and firmware updates; Ethernet port enabling remote configuration, live data streaming, and centralized fleet management via FMS 5 software platform.
• Long-life laser diode with stable output intensity over rated service life—minimizing drift-related recalibration frequency in routine QC applications.
• Optional integrated temperature and relative humidity sensor (±0.5 °C, ±3 %RH accuracy) provides contextual environmental data synchronized with particle counts for comprehensive environmental qualification reports.

Sample Compatibility & Compliance

The Model 9306 is validated for use with ambient air, compressed gases (via optional pressure-regulated inlet), and filtered process air streams within Class 1–Class 8 cleanroom environments per ISO 14644-1. Its optical design and flow control architecture meet the rigorous requirements of ISO 21501-4 for light-scattering particle counters—including pulse height linearity, counting efficiency, false count rate, and size resolution verification. The instrument supports audit-ready reporting for FDA-regulated facilities under 21 CFR Part 11 when used with TrakPro™ Lite (with electronic signature and audit trail modules enabled) or FMS 5 enterprise software. Calibration certificates include NIST-traceable uncertainty statements and are generated per ISO/IEC 17025–accredited procedures performed at TSI’s metrology laboratory.

Software & Data Management

Data acquisition, analysis, and compliance reporting are managed through two complementary software ecosystems. TrakPro™ Lite offers desktop-based post-processing, customizable report generation (PDF/CSV), and GLP-compliant audit trails—including user login history, parameter change logs, and data export timestamps. For continuous monitoring networks, the Model 9306 integrates natively into FMS 5 (Facility Monitoring System), supporting real-time dashboard visualization, alarm thresholds with email/SNMP notification, and automated report scheduling aligned with ISO 14644-2 surveillance intervals. All stored datasets retain native metadata (GPS coordinates if enabled via external module, operator ID, sampling duration, and environmental conditions), ensuring full traceability throughout the data lifecycle.

Applications

• Cleanroom certification and routine monitoring per ISO 14644-1 and EU GMP Annex 1 requirements in pharmaceutical, biotechnology, and medical device manufacturing.
• HVAC system performance validation—including filter integrity testing (e.g., upstream/downstream scanning), airflow uniformity assessment, and recovery time evaluation.
• Contamination investigation in aseptic processing suites, isolators, and RABS environments.
• Environmental baseline characterization during facility commissioning, qualification (IQ/OQ/PQ), and periodic requalification cycles.
• Field-based indoor air quality (IAQ) assessments in laboratories, hospitals, and semiconductor fabrication support areas.

FAQ

What standards does the Model 9306 comply with for calibration and performance verification?
It conforms to ISO 21501-4 for light-scattering airborne particle counters, with calibration traceable to NIST Standard Reference Materials (SRMs) using PSL spheres. Factory verification includes counting efficiency, size resolution, and false count rate tests per Clause 6 of the standard.
Can the instrument operate continuously while charging?
Yes—the removable Li-ion battery supports hot-swap operation; the unit remains functional during external power supply connection without interruption to sampling or data logging.
Is remote firmware update supported?
Firmware updates are delivered via USB or Ethernet using TSI-provided update packages and require administrator-level authentication to maintain system integrity and regulatory compliance.
How is data security ensured during network transmission?
Ethernet communication uses TLS 1.2 encryption for data-in-transit; FMS 5 deployments support role-based access control (RBAC), encrypted database storage, and configurable session timeouts aligned with HIPAA and GDPR technical safeguards.
Does the Model 9306 support 21 CFR Part 11 compliance out of the box?
Out-of-the-box hardware meets technical requirements (audit trail capability, electronic signatures); full Part 11 compliance requires deployment with TrakPro™ Lite v5.2+ or FMS 5 v4.0+, configured with enabled audit trail, user authentication, and electronic signature modules per site-specific validation protocols.