TSI AeroTrak 9310/9350 Portable Laser Particle Counter

Overview

The TSI AeroTrak 9310 and 9350 Portable Laser Particle Counters are precision-engineered instruments designed for real-time, high-fidelity airborne particle monitoring in regulated and research environments. Utilizing a stable 650 nm laser diode light source and a calibrated optical sensing chamber, these devices employ the principle of single-particle light scattering to detect and size individual particles across six user-selectable channels. The 9310 model offers sensitivity down to 0.3 µm with 50% counting efficiency at that threshold (per JIS B9921), while the 9350 provides enhanced signal-to-noise performance for applications where larger particle fractions dominate—achieving 50% efficiency at 0.5 µm. Both models feature true isokinetic sampling via integrated velocity-matched probes, ensuring representative sample collection from laminar or turbulent airstreams without bias. Their dual-mode operation—standalone field deployment or networked integration into centralized environmental monitoring systems (EMS)—makes them suitable for both mobile audits and permanent facility qualification.

Key Features

• High-flow sampling architecture: 28.3 L/min (9310) and 50 L/min (9350), enabling rapid statistical confidence in low-concentration environments and accelerated mapping of cleanroom classifications per ISO 14644-1.
• Rugged stainless steel enclosure rated for continuous operation in ISO Class 5–8 environments; IP54-rated ingress protection against dust and incidental moisture.
• Integrated thermal printer (optional) supports on-the-spot generation of audit-ready reports compliant with ISO 14644-1, FS-209E, and EC GMP Annex 1 requirements—including timestamped, operator-identified printouts with full channel data.
• Onboard data management: 10,000 sample records stored with password-protected access, supporting date/time stamping, location tagging (up to 250 named test positions), and configurable alarm thresholds for particle excursions.
• Real-time acoustic alert system triggers audible warnings upon exceeding user-defined concentration limits—critical for immediate intervention during contamination events in aseptic processing suites.
• Self-diagnostic firmware continuously monitors pump performance, flow stability (±5% accuracy maintained via closed-loop mass flow control), sensor zero drift (<1 count/5 min), and battery health—ensuring measurement integrity throughout each shift.

Sample Compatibility & Compliance

The AeroTrak 9310/9350 series is validated for use with standard cleanroom-grade sampling tubing (3 m included), isokinetic probes, and HEPA-filtered exhaust. It meets the metrological requirements of JIS B9921 for zero-count stability and counting efficiency, and its calibration is traceable to NIST Standard Reference Materials. Instrument output conforms to regulatory reporting frameworks including ISO 14644-1:2015 (cleanroom classification), US Federal Standard FS-209E (withdrawn but still referenced), and EU GMP Annex 1 (2022 revision) for viable and non-viable particle monitoring in Grade A–D environments. Data export protocols support 21 CFR Part 11-compliant workflows when used with TRAKPRO™ Software v5.0 or later, enabling electronic signatures, audit trails, and role-based access control.

Software & Data Management

TRAKPRO™ Data Analysis Software (included) provides post-acquisition visualization, statistical trending (e.g., UCL calculation per ISO 14644-2), and automated report generation. Raw binary files (.trk) retain full metadata—including GPS coordinates (when paired with optional external module), operator ID, environmental conditions (temperature/humidity logged via external sensors), and instrument configuration history. USB 2.0 and Ethernet (TCP/IP) interfaces allow secure transfer to laboratory information management systems (LIMS) or enterprise EMS platforms. All stored data includes immutable timestamps and supports digital signature embedding for GLP/GMP audit readiness.

Applications

• Cleanroom certification and routine monitoring per ISO 14644-1, particularly for Grade A isolators and Grade B background areas in pharmaceutical manufacturing.
• Filter integrity validation—including HEPA and ULPA testing—via upstream/downstream challenge measurements and leak scanning protocols.
• Contamination migration studies during equipment qualification, gowning validation, and process simulation (media fill) activities.
• Indoor air quality (IAQ) assessments in hospitals, laboratories, and semiconductor fabrication facilities where submicron particle dynamics influence operational risk.
• Occupational exposure assessment for aerosolized particulates in R&D, nanomaterial handling, and powder processing environments.

FAQ

What standards does the AeroTrak 9310/9350 comply with for cleanroom certification?

It fully supports ISO 14644-1:2015, FS-209E, and EC GMP Annex 1 reporting formats—including automatic calculation of classification limits and UCL values.
Can the instrument operate unattended for extended periods?

Yes—programmable sampling schedules (1 sec to 99 hr duration, 1–9999 cycles or continuous mode) enable overnight or weekend monitoring without manual intervention.
Is remote data access possible during live sampling?

When connected via Ethernet, real-time streaming of particle counts and status telemetry is supported using standard TCP/IP sockets, enabling integration with SCADA or cloud-based dashboards.
How is calibration maintained between service intervals?

Built-in zero-check functionality verifies baseline stability every 5 minutes; annual NIST-traceable recalibration is recommended, with optional on-site verification kits available through TSI Authorized Service Centers.
Does the device meet FDA 21 CFR Part 11 requirements for electronic records?

When used with TRAKPRO™ v5.0+ and configured with user authentication, audit trail logging, and electronic signatures, it satisfies predicate rule requirements for regulated pharmaceutical and biotech applications.