HRH-LPC5 Series Portable Laser Particle Counter

Overview

The HRH-LPC5 Series Portable Laser Particle Counter is a precision-engineered instrument designed for real-time, in-situ quantification of airborne particulate contamination in controlled environments. Based on the principle of single-particle light scattering (SPLS) using a stable semiconductor laser source, it detects and classifies particles by size through calibrated optical sensing and pulse-height analysis. The device operates in accordance with internationally recognized cleanroom classification standards—including ISO 14644-1 (1999 and 2015 editions), GB/T 25915.1–2021, and EU GMP Annex 1—enabling direct compliance verification without post-processing. Its portability, robust 304 stainless steel housing, and integrated thermal printer make it suitable for routine monitoring, qualification studies, and periodic re-certification of cleanrooms across Class 1 to Class 8 (ISO 3–8) environments.

Key Features

• Triple-tier user authentication with full audit trail functionality compliant with FDA 21 CFR Part 11 requirements for electronic records and signatures.
• Configurable sampling protocols: discrete point measurement, continuous scanning mode, zero calibration, and purge cycle for baseline stabilization.
• Up to 200 predefined zones and 999 sampling locations per zone—ideal for large-scale facility mapping and ISO 14644-2 surveillance planning.
• Real-time UCL (Upper Confidence Limit) calculation per ISO 14644-1 Annex D, supporting statistically valid classification reports.
• Self-regulating sampling airflow via closed-loop feedback from an integrated thermal mass flow sensor—ensuring ±2% volumetric accuracy across operating conditions.
• 7-inch capacitive touchscreen interface with intuitive icon-driven navigation, multilingual support (English, Chinese), and context-sensitive help.
• Onboard thermal printer enables immediate hardcopy output of raw counts, trend charts, pass/fail status, and full compliance reports.
• High-capacity internal memory stores ≥10,000 measurement records; data export via USB flash drive in CSV or PDF format for LIMS integration.
• Chemical-resistant 304 stainless steel enclosure rated IP54 for dust and splash protection—compatible with isopropyl alcohol (IPA), hydrogen peroxide vapor (HPV), and other common cleanroom disinfectants.

Sample Compatibility & Compliance

The HRH-LPC5 Series is validated for use in non-hazardous, non-explosive ambient air sampling only. It is not intended for compressed gas lines, vacuum systems, or aerosolized biohazards without prior validation and engineering controls. All models comply with electromagnetic compatibility (EMC) per IEC 61326-1 and safety requirements per IEC 61010-1. Calibration traceability follows NIST-traceable reference aerosols (e.g., PSL spheres) and is documented per ISO/IEC 17025 guidelines. Instrument firmware supports configurable alarm thresholds per channel, with audible alerts at user-defined frequencies—critical for dynamic cleanroom process monitoring under GLP/GMP frameworks.

Software & Data Management

Data acquisition and reporting are managed through embedded firmware with no external PC dependency. Raw particle count data, timestamp, location ID, environmental parameters (temperature/humidity/pressure), and operator credentials are logged with microsecond resolution. Exported files include metadata headers required for regulatory submissions (e.g., FDA eCTD, EMA CTD). Optional PC-based companion software (HRH-DataLink v3.x) provides advanced visualization, statistical process control (SPC) charting, and automated report generation aligned with ISO 14644-2 surveillance intervals. Audit logs record all configuration changes, user logins, and calibration events—retained for ≥12 months unless manually archived.

Applications

The HRH-LPC5 Series serves critical quality assurance functions across regulated and high-precision industries: semiconductor wafer fabrication (Class 1–10 cleanrooms), LCD/OLED panel manufacturing, aseptic pharmaceutical filling suites (Grade A/B), medical device packaging lines, aerospace component assembly, nanomaterial synthesis labs, and university cleanroom teaching facilities. Its multi-flow options (28.3, 50, and 100 L/min) allow method alignment with ISO 14644-1 sampling volume requirements—from small isolators to large production bays. Field technicians routinely deploy it for HVAC performance validation, filter integrity testing, and root-cause analysis during out-of-specification (OOS) events.

FAQ

Does the HRH-LPC5 Series require annual recalibration?
Yes—annual recalibration against NIST-traceable PSL standards is recommended per ISO/IEC 17025 and internal quality management systems. Field verification using zero-air and challenge aerosols should be performed before each shift.
Can the device connect to a central monitoring system?
Yes—via Ethernet or RS485 Modbus RTU, enabling integration into BMS or SCADA platforms for centralized alarm management and historical trending.
Is battery operation validated for GMP environments?
Yes—the lithium-ion battery pack meets IEC 62133 and is certified for use in non-classified support areas adjacent to Grade A/B zones; runtime is verified under worst-case temperature/humidity conditions.
How is data integrity ensured during USB export?
All exported files include SHA-256 checksums and digital signatures tied to the instrument’s unique serial number and firmware version—preventing tampering and supporting ALCOA+ principles.
What particle size resolution does the optical system provide?
The laser scattering optics resolve six discrete channels (0.3, 0.5, 1.0, 2.5, 5.0, 10.0 µm) with ≤15% counting efficiency uncertainty per ISO 21501-4, with optional firmware upgrade to eight-channel detection.