TSI AeroTrak 7301-P Remote Laser Particle Counter
| Brand | TSI |
|---|---|
| Origin | USA |
| Model | 7301-P |
| Instrument Type | Online Particle Counter |
| Flow Rate | 2.83 L/min (0.1 CFM) |
| Particle Size Range | 0.3–50 µm |
| Selectable Size Channels | 0.3, 0.5, 1.0, 2.0, 2.5, and 5.0 µm (user-selectable triple-channel configuration) |
| Compliance | ISO 21501-4 |
| Data Output | TCP/IP Ethernet + RS-485 Modbus® RTU |
| Onboard Storage | 3,000 sample records |
| Mounting | Ceiling-mountable, UL 2043 listed |
| Power | Internal vacuum pump with integrated exhaust filtration |
| Operating Environment | Low-noise design for cleanrooms, pharmacies, isolation rooms, and office spaces |
| Warranty | 2 years |
Overview
The TSI AeroTrak 7301-P Remote Laser Particle Counter is an ISO 21501-4 compliant, network-enabled optical particle counter engineered for continuous, unattended monitoring of airborne particulate concentration in critical environments. It operates on the principle of single-particle light scattering: aerosol-laden air is drawn through a precisely controlled laminar flow path at 2.83 L/min (0.1 CFM), where particles pass through a focused laser beam; scattered light intensity is detected and classified into user-defined size bins (0.3, 0.5, 1.0, 2.0, 2.5, or 5.0 µm — three channels selected per configuration). The instrument’s internal vacuum source eliminates dependency on external sampling pumps, enabling flexible installation—including ceiling-mounted deployment in ISO Class 5–8 cleanrooms, USP pharmacy compounding areas, and healthcare isolation zones—without compromising flow stability or measurement integrity.
Key Features
- Integrated vacuum pump with exhaust filtration ensures stable 2.83 L/min sampling flow without external infrastructure.
- Triple-channel size binning from six calibrated thresholds (0.3–5.0 µm), traceably validated against NIST-traceable PSL standards using TSI’s proprietary classification and CPC verification methodology.
- Dual communication interface: native TCP/IP Ethernet for integration into facility management systems (e.g., TSI FMS 5), plus RS-485 Modbus® RTU for legacy SCADA or BMS compatibility.
- Onboard non-volatile memory stores up to 3,000 timestamped sample records with full channel resolution, supporting audit-ready data retention during network outages.
- UL 2043-rated housing with low acoustic emission (<45 dB[A]) permits installation in noise-sensitive locations including hospital pharmacies, cleanroom support corridors, and administrative offices.
- Web-based configuration interface enables remote setup, firmware updates, alarm threshold definition, and real-time status monitoring via standard browsers—no proprietary software required.
Sample Compatibility & Compliance
The 7301-P is validated for use with ambient air, HEPA-filtered supply air, and recirculated airstreams typical of pharmaceutical manufacturing, biotech labs, and healthcare facilities. Its optical design and flow control architecture meet the performance requirements of ISO 21501-4 for light-scattering airborne particle counters. Calibration traceability is maintained through documented comparison to NIST-traceable polystyrene latex (PSL) reference particles, verified using TSI’s certified condensation particle counter (CPC) and aerodynamic classification system. The device supports compliance workflows for USP , EU GMP Annex 1, ISO 14644-1/2, and FDA 21 CFR Part 11 when deployed with appropriate data governance protocols—including secure user authentication, electronic signatures, and audit trail generation via compatible enterprise platforms.
Software & Data Management
Data acquisition and system configuration are managed via embedded HTTP server accessible over local or wide-area networks. Each sample record includes UTC timestamp, all active channel counts, flow status, laser health indicator, and internal temperature/humidity (optional sensor). Export formats include CSV and XML for direct ingestion into LIMS, MES, or statistical process control (SPC) platforms. When integrated with TSI FMS 5 or third-party SCADA systems via Modbus® RTU, the 7301-P supports automated alarm escalation (e.g., email/SNMP traps upon threshold breach), trend visualization, and long-term historical analysis. All configuration changes are logged with user ID and timestamp, satisfying GLP/GMP documentation requirements for change control.
Applications
- Continuous environmental monitoring in USP and sterile compounding pharmacies.
- Real-time particle surveillance in ISO 14644-classified cleanrooms used for medical device assembly or aseptic processing.
- Performance validation and routine testing of HEPA/ULPA filters and HVAC airflow uniformity.
- Occupancy-triggered monitoring in isolation rooms and negative-pressure containment suites.
- Baseline characterization and contamination event forensics in semiconductor fabrication support areas.
- Regulatory audit preparation for FDA, EMA, or MHRA inspections requiring documented particulate control evidence.
FAQ
What calibration standards does the 7301-P follow?
It complies with ISO 21501-4 and is factory-calibrated using NIST-traceable PSL particles, with verification performed using TSI’s certified CPC and aerosol classification system.
Can the 7301-P operate without network connectivity?
Yes—onboard storage retains 3,000 samples locally; data syncs automatically upon network restoration.
Is ceiling mounting supported and certified?
Yes—the unit is UL 2043 listed for plenum-rated installation and includes hardware for secure overhead mounting per ISO 14644-3 guidelines.
Does it support 21 CFR Part 11 compliance?
The device provides foundational capabilities (audit trails, user access control, electronic signatures via integrated platform); full Part 11 compliance requires implementation within a validated enterprise software environment.
What is the expected lifetime of the laser diode?
Rated for >50,000 hours of continuous operation under specified thermal and power conditions, ensuring multi-year service life without recalibration drift.
