TSI AeroTrak®+ Portable Particle Counter A100 Series

Overview

The TSI AeroTrak®+ Portable Particle Counter A100 Series is a precision-engineered, ISO 21501-4:2018 compliant optical particle counter designed for real-time, high-fidelity airborne particulate monitoring in regulated and mission-critical environments. Utilizing calibrated laser diode light scattering technology with dual-channel pulse-height analysis, the A100 Series detects and sizes particles from 0.3 µm to 10.0 µm across six user-selectable size channels (e.g., ≥0.3, ≥0.5, ≥1.0, ≥3.0, ≥5.0, ≥10.0 µm), delivering traceable, repeatable concentration data in particles per cubic meter (pt/m³) or particles per cubic foot (pt/ft³). Its compact, battery-powered form factor—combined with integrated environmental sensors (temperature, relative humidity, pressure)—enables rapid deployment for cleanroom classification (per ISO 14644-1:2015), HEPA filter integrity testing (via upstream/downstream scanning), and contamination investigation workflows. The instrument operates under strict metrological control, with factory-applied volumetric correction factors applied in real time to ensure accurate sample volume calculation across varying ambient conditions.

Key Features

• Laser-based optical detection system certified to ISO 21501-4:2018 calibration requirements, with 5-year laser diode warranty
• Real-time LED status bar visible at 20 meters and 360°—providing immediate visual feedback on operational state, alarm thresholds, and sampling progress
• Configurable user access levels supporting GMP-compliant role-based permissions (e.g., Operator, Supervisor, Administrator)
• Onboard generation of audit-ready reports aligned with ISO 14644-1:2015, EU GMP Annex 1 (2022), and China GMP requirements
• Dual-mode HEPA leak detection: simultaneous audio tone modulation and visual intensity mapping for rapid identification of penetration sites
• Stainless steel enclosure rated IP54 for durability, chemical resistance, and ease of decontamination in aseptic environments
• Flexible connectivity via Wi-Fi®, USB-C, and 4–20 mA analog output; supports integration with SCADA, BMS, and centralized monitoring platforms
• Internal environmental sensor suite (±0.5 °C temp, ±2% RH, ±0.5 kPa pressure) enabling automatic flow compensation and volumetric normalization

Sample Compatibility & Compliance

The A100 Series is validated for use with compressed gases (including nitrogen, air, and process gases), ambient indoor air, and controlled cleanroom atmospheres. It complies with regulatory frameworks governing data integrity and instrument qualification, including FDA 21 CFR Part 11 (electronic records/signatures), EU Annex 11 (computerized systems), and ISO/IEC 17025 requirements for measurement uncertainty reporting. All firmware and TrakPro™ Lite Secure software modules are developed under a documented software lifecycle management process, supporting full ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Instrument qualification documentation—including IQ/OQ templates and calibration certificates traceable to NIST standards—is provided with each unit.

Software & Data Management

TrakPro™ Lite Secure v3.0 serves as the embedded and PC-based data acquisition and reporting engine. It enforces secure login, session timeouts, electronic signature workflows, and immutable audit trails for all configuration changes, report generation, and data export actions. Raw particle count data is stored in encrypted SQLite databases with SHA-256 hashing; exported reports include digital signatures and timestamped metadata required for GLP/GMP audits. The software supports batch reporting, statistical trending (e.g., UCL calculations per ISO 14644-1), and customizable PDF/CSV outputs compliant with internal SOPs and external regulatory submissions. Remote firmware updates are authenticated via TLS 1.2 and digitally signed by TSI.

Applications

• Pharmaceutical manufacturing: Routine environmental monitoring (EM) in Grade A/B/C/D zones, root cause analysis during OOS events, and media fill support
• Semiconductor fabrication: Cleanroom certification, tool chamber verification, and nanoparticle emission characterization during etch/CVD processes
• Medical device production: Packaging line qualification, isolator validation, and sterility assurance program execution
• Aerospace & defense: Contamination control in avionics assembly bays and propulsion system test facilities
• Research laboratories: Aerosol generation studies, filtration efficiency benchmarking, and HVAC performance evaluation

FAQ

Does the A100 Series meet ISO 21501-4:2018 calibration requirements?
Yes—the instrument undergoes full optical calibration using NIST-traceable PSL standards and includes a Certificate of Calibration with uncertainty values stated per ISO/IEC 17025.
Can it be used for HEPA filter leak testing in accordance with IEST-RP-CC034.3?
Yes—its dual-mode (audio + visual) scanning mode and programmable dwell time enable compliance with IEST and ISO 14644-3 protocols for filter integrity verification.
Is TrakPro™ Lite Secure qualified for use in FDA-regulated environments?
Yes—it is delivered with a complete validation package (URS, FRS, IQ/OQ protocols, and risk assessment) supporting 21 CFR Part 11 compliance.
What environmental parameters are measured internally?
Ambient temperature (±0.5 °C), relative humidity (±2% RH), and barometric pressure (±0.5 kPa) are continuously monitored and applied to volumetric correction algorithms.
How is data integrity ensured during field operation?
All measurements are timestamped, digitally signed, and stored in tamper-evident database structures; manual data entry is disabled, and configuration changes require multi-level authentication.