HuRongHe HRH-LPC1301 Handheld Laser Particle Counter

Overview

The HuRongHe HRH-LPC1301 Handheld Laser Particle Counter is a precision-engineered optical instrument designed for real-time, in-situ monitoring of airborne particulate contamination in controlled environments. It operates on the principle of single-particle light scattering: a collimated laser beam interrogates aerosolized particles drawn through the sensing volume; scattered light intensity is detected and classified into discrete size bins based on calibrated Mie scattering response. This enables quantitative determination of particle concentration per cubic meter (or cubic foot) across six standard size channels—0.3, 0.5, 1.0, 2.5, 5.0, and 10.0 µm—with optional expansion to eight channels for enhanced resolution in specialized applications. The device is explicitly intended for use in ISO Class 3–8 cleanrooms, aseptic processing suites, laminar flow hoods, and critical manufacturing zones where adherence to international cleanliness specifications is mandated by regulatory or quality assurance frameworks.

Key Features

• Integrated high-precision mass flow sensor and brushless diaphragm pump with active flow regulation—maintains stable 2.83 L/min sampling rate within ±3% tolerance across variable backpressure conditions.
• Three-tier user access control (Operator, Supervisor, Administrator) with full audit trail logging compliant with ALCOA+ principles—including timestamped actions, parameter changes, and report generation events.
• Configurable sampling protocols: discrete point measurement, continuous scanning mode, zero calibration, and purge cycle—each programmable with custom duration, interval, and trigger logic.
• Preloaded compliance engine supporting eight major cleanroom standards: ISO 14644-1:2015, ISO 14644-1:1999, GB/T 25915.1–2021, GB 50073–2013, YY 0033–2000, Chinese GMP (2010), EU GMP Annex 1 (2022), and legacy FED-STD-209E.
• On-device UCL (Upper Confidence Limit) calculation per ISO 14644-1 Annex D, enabling automated classification of cleanroom grade from raw count data.
• 4-inch capacitive touch display with intuitive icon-driven UI; supports multi-language overlay (English, Simplified Chinese) and customizable screen layouts for rapid field operation.
• Internal non-volatile memory stores up to 10,000 complete sample records, each containing channel-resolved counts, environmental metadata (T/RH/pressure), operator ID, location tag, and GPS-derived coordinates (optional).

Sample Compatibility & Compliance

The HRH-LPC1301 is validated for use with ambient air, compressed gases (N₂, dry air, CO₂), and filtered process air streams in non-explosive, non-corrosive environments. It is not rated for hazardous area use (ATEX/IECEx) or high-humidity condensing conditions (>75 %RH). Its measurement traceability aligns with national metrological standards referenced in JJF 1190–2008 (Calibration Specification for Airborne Particle Counters) and supports GLP/GMP-aligned workflows through configurable electronic signatures, immutable data export (CSV/Excel), and full 21 CFR Part 11 readiness when paired with validated software platforms. All firmware and calibration certificates are version-controlled and subject to documented change management per ISO 9001:2015 Clause 8.5.2.

Software & Data Management

Data retrieval occurs via USB mass storage mode or Ethernet TCP/IP connection using industry-standard Modbus TCP or HTTP RESTful endpoints. Raw datasets export directly to USB flash drives in CSV format, preserving all metadata fields required for regulatory submission (e.g., FDA eCTD Module 3, EMA Annex 11 validation reports). Optional PC-based analysis suite provides advanced visualization tools—including temporal trend charts, spatial heatmaps, statistical process control (SPC) charts, and automated deviation alerts against pre-defined action/alert limits. Audit logs are encrypted and time-stamped using NTP-synchronized clocks; no local data deletion capability exists without administrative override and dual-signature authorization.

Applications

This instrument serves as a primary verification tool across regulated and high-precision sectors: semiconductor fab line environmental qualification (per SEMI S2/S8), pharmaceutical isolator certification (ISO 14644-3 Annex B), biotech cleanroom requalification after maintenance, medical device packaging line monitoring, LCD panel assembly room surveillance, aerospace avionics clean bench validation, and university nanomaterial synthesis lab containment assessment. Its portability and battery autonomy make it suitable for mobile audits, vendor qualification visits, and cross-facility benchmarking studies requiring consistent metrological equivalence.

FAQ

What calibration standards does the HRH-LPC1301 support?
It is factory-calibrated using NIST-traceable PSL (polystyrene latex) spheres and conforms to ISO 21501-4:2018 for light-scattering airborne particle counter performance verification.
Can the device be used in ISO Class 1 or 2 environments?
While capable of detecting sub-0.3 µm particles, its specified lower detection limit is 0.3 µm; therefore, it is not recommended for ISO Class 1 (≤10 particles/m³ @ 0.1 µm) or Class 2 qualification per ISO 14644-1:2015.
Is firmware update functionality available over-the-air?
Firmware updates require secure USB delivery and manual installation under administrator privileges; no remote or wireless update mechanism is implemented to preserve system integrity and regulatory compliance.
Does the unit meet FDA 21 CFR Part 11 requirements out-of-the-box?
Yes—when deployed with enabled audit trail, electronic signature, and role-based access controls, it satisfies core Part 11 criteria; full validation documentation package is provided upon request.
How is flow accuracy verified during routine use?
An integrated self-check sequence validates pump performance and flow sensor output at power-on and every 24 hours during continuous operation; deviation triggers audible alarm and disables sampling until recalibration.