HengaoDe HAD-CLJ-350 High-Flow Laser Particle Counter for Cleanroom Environmental Monitoring

Overview

The HengaoDe HAD-CLJ-350 is a high-flow, portable laser particle counter engineered for quantitative airborne particulate monitoring in regulated clean environments. It operates on the principle of light scattering—where particles drawn through a focused semiconductor laser beam generate scattered photons detected by a high-sensitivity photodiode array. Signal processing algorithms convert pulse amplitude and frequency into real-time particle counts per cubic meter across six user-selectable size thresholds (0.3 to 10.0 µm). Designed in strict alignment with ISO 14644-1:2015, GB 50073-2001, and China’s Good Manufacturing Practice (GMP) Annex 1 (2010 edition), the instrument supports static and dynamic classification of cleanrooms per ISO Class 1–9 and GMP Grades A–D. Its 316L stainless steel housing ensures chemical resistance and electrostatic discharge (ESD) control, while the optimized scattering chamber minimizes stray light and maximizes signal-to-noise ratio—critical for low-concentration detection at 0.3 µm with <5% coincidence error at 2×10⁶ particles/ft³.

Key Features

• High-volume sampling at 50 L/min enables statistically robust data collection in accordance with ISO 14644-1 sampling plan requirements for large-area cleanrooms and isolators.
• Simultaneous six-channel particle sizing (0.3, 0.5, 1.0, 3.0, 5.0, 10.0 µm) with configurable thresholds—supports both regulatory compliance reporting and process troubleshooting.
• Integrated LCD interface (122 × 90 mm) with dual-language support (English/Chinese), real-time concentration display, timestamped logging, and on-device 95% Upper Confidence Limit (UCL) calculation per ISO 14644-1 Annex B.
• Built-in thermal printer eliminates dependency on external PCs for audit-ready hardcopy reports during qualification or routine monitoring.
• Non-volatile memory stores up to 1,000 complete measurement sets—including particle counts per channel, ambient temperature/humidity (optional), sampling location ID, date/time stamp, volume sampled, and operator-defined metadata.
• RS232 serial interface (9600 baud) enables direct integration with LIMS, MES, or SCADA systems; compatible with standard cleanroom monitoring software via provided communication protocol documentation.

Sample Compatibility & Compliance

The HAD-CLJ-350 is validated for use in non-hazardous, non-corrosive indoor air environments typical of pharmaceutical manufacturing suites, aseptic filling lines, microelectronics fabrication cleanrooms, biotech laboratories, and medical device assembly areas. It meets mechanical and electrical safety requirements per GB 4793.1–2007 (equivalent to IEC 61010-1). All optical and electronic subsystems are calibrated traceably to the National Institute of Standards and Technology (NIST) via the Shanghai Institute of Measurement and Testing Technology—certified under JJF-1190-2008, the national metrological verification regulation for particle counters. The instrument supports full audit trail capability when paired with compliant data acquisition software, satisfying data integrity expectations under China’s NMPA GMP Annex 1 and general principles of ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

Software & Data Management

While the HAD-CLJ-350 operates autonomously with on-device data storage and printing, its RS232 interface allows bidirectional communication with third-party environmental monitoring platforms. Supplied software (Windows-compatible) provides configuration management, report generation (PDF/CSV), UCL validation plots, and deviation flagging against pre-set limits (e.g., ISO Class 5, GMP Grade A). Data export includes full metadata: sampling point ID, operator code, environmental conditions, duration, flow rate confirmation, and calibration status. The system supports 21 CFR Part 11–compliant electronic signatures when deployed with validated enterprise software—though native instrument firmware does not include role-based access control or electronic signature functionality.

Applications

• Cleanroom certification and routine monitoring per ISO 14644-1 and GMP Annex 1 (static/dynamic testing of Grade A–D zones)
• Aseptic process simulation (media fill) environmental assessment
• Filter integrity verification (HEPA/ULPA) via upstream/downstream challenge testing
• Equipment qualification (IQ/OQ/PQ) of laminar flow cabinets, isolators, and RABS
• Particle source identification and contamination investigation in semiconductor fabs
• Regulatory submission support (e.g., FDA, EMA, NMPA) with fully documented, traceable datasets

FAQ

Is the HAD-CLJ-350 compliant with ISO 14644-1:2015 and GMP (2010) Annex 1?

Yes—the instrument’s counting efficiency, size resolution, and UCL calculation logic are verified per ISO 21501-4 and JJF-1190-2008, enabling direct application in cleanroom classification per ISO 14644-1 and GMP Annex 1.

Can it measure temperature and humidity simultaneously with particle counts?

Optional integrated sensors provide concurrent temperature (±1 °C) and relative humidity (±5% RH) readings, logged alongside particle data for comprehensive environmental correlation.

What is the calibration interval recommendation?

Annual calibration is recommended per JJF-1190-2008; users may perform intermediate verification using NIST-traceable polystyrene latex (PSL) standards.

Does it support remote operation or network connectivity?

It features RS232 only; Ethernet or Wi-Fi modules are not available. Remote control requires serial-to-IP gateway integration at the system level.

Is the internal printer replaceable or serviceable?

The built-in thermal printer uses standard 58 mm thermal paper rolls and is field-serviceable with OEM spare parts.