TSI AeroTrak 9110 Portable Laser Particle Counter

Overview

The TSI AeroTrak 9110 Portable Laser Particle Counter is an ISO 21501-4 compliant, handheld optical particle counter engineered for high-fidelity airborne particulate monitoring in critical environments. It employs a stabilized helium–neon (HeNe) laser source operating at 632.8 nm to illuminate aerosol particles drawn through its calibrated 28.3 L/min (1 CFM) volumetric flow path. Scattered light intensity is captured by a high-gain photodetector array and converted into discrete particle counts across eight user-selectable size channels—from 0.100 µm up to 5.0 µm—enabling quantitative assessment of sub-micron contamination relevant to ISO Class 1 through Class 5 cleanrooms. Unlike lower-cost diode-laser-based counters, the HeNe architecture delivers superior signal-to-noise ratio, reduced coincidence error at elevated concentrations, and long-term optical stability essential for audit-ready validation studies. Its design conforms strictly to the metrological requirements of ISO 21501-4 for light-scattering airborne particle counters, including specified resolution, counting efficiency, false count rate, and size calibration traceability to NIST-certified polystyrene latex (PSL) reference materials.

Key Features

• High-sensitivity detection down to 0.100 µm using a temperature-stabilized HeNe laser source
• Simultaneous 8-channel size binning with programmable thresholds aligned to ISO 14644-1 and EU GMP Annex 1 reporting structures
• 28.3 L/min (1 CFM) constant-flow sampling system with integrated mass flow sensor and automatic pressure/temperature compensation
• Onboard data storage capacity for 10,000 timestamped records across up to 999 unique sampling locations
• Dual-mode operation: standalone field use or networked integration via Ethernet or USB with TSI FMS5 Facility Monitoring Systems
• Real-time visual and audible alarms configurable per channel or cumulative concentration threshold
• Stainless-steel inlet and probe interface compatible with TSI M32-01 multi-point manifold for automated spatial mapping
• Full audit trail support including operator ID, location tag, and instrument serial number embedded in every exported dataset

Sample Compatibility & Compliance

The AeroTrak 9110 is validated for use in regulated pharmaceutical, semiconductor, and medical device manufacturing environments where adherence to international cleanliness standards is mandatory. It meets the performance criteria defined in ISO 14644-1:2015 for classification and monitoring of cleanrooms and associated controlled environments—specifically supporting verification of ISO Class 1 (≤10 particles/m³ ≥0.1 µm) and Class 2 (≤100 particles/m³ ≥0.1 µm) spaces. Calibration is performed using NIST-traceable PSL spheres, processed through TSI’s certified aerosol generation and sizing infrastructure—including the 3080 Electrostatic Classifier and 3776 Condensation Particle Counter—to ensure compliance with ISO 21501-4 Annex B. The instrument supports 21 CFR Part 11-compliant data handling when used with TSI’s TrakPro™ Lite software, enabling electronic signatures, secure user access controls, and immutable audit logs required under FDA and EMA regulatory frameworks.

Software & Data Management

Data acquisition, analysis, and reporting are managed through TSI’s TrakPro™ Lite software—a Windows-based application qualified for GxP environments. It enables automated generation of ISO 14644-1 pass/fail reports, trend analysis over time, overlay of multiple sampling points, and export to CSV, PDF, or XML formats compliant with laboratory information management systems (LIMS). All raw count data retain full metadata: GPS coordinates (when enabled), ambient temperature/humidity/pressure (via optional sensors), battery status, and firmware revision. The system supports scheduled calibration reminders, firmware update logging, and configuration lock-down modes to prevent unauthorized parameter changes during qualification protocols.

Applications

• ISO 14644-1 cleanroom certification and routine surveillance in microelectronics fabrication facilities
• Filter integrity testing of ULPA and HEPA installations in aseptic processing suites
• In-process monitoring of isolators, RABS, and gloveboxes during sterile drug manufacturing
• Environmental baseline characterization prior to equipment qualification (IQ/OQ)
• Investigation of particle excursions and root cause analysis in contamination control investigations
• Multi-point spatial mapping using the M32-01 manifold for airflow pattern validation and turbulence assessment

FAQ

Does the AeroTrak 9110 require annual recalibration?
Yes. TSI recommends annual recalibration against NIST-traceable PSL standards to maintain ISO 21501-4 conformance and regulatory acceptability.
Can it be used for outdoor ambient air monitoring?
It is not designed for unfiltered ambient air due to potential sensor overload; however, it may be deployed downstream of appropriate inertial or cyclonic pre-separators for coarse particulate exclusion.
Is the instrument suitable for compressed gas testing?
No—direct sampling of compressed gases is not supported. For compressed air monitoring, TSI recommends the 9555-A or 9555-X series with dedicated pressure-reduction modules.
What is the warranty period and service coverage?
The AeroTrak 9110 carries a standard 24-month limited warranty covering parts and labor, extendable to 36 months with TSI’s CarePlus maintenance agreement.
How does it handle data integrity during power interruption?
All measurements are written to non-volatile flash memory in real time; no data is lost during unexpected shutdown or battery depletion.