HJ Y09-310AC-DC Laser Particle Counter

Overview

The HJ Y09-310AC-DC Laser Particle Counter is a laboratory-grade, portable airborne particle monitoring instrument engineered for high-fidelity quantitative analysis of particulate contamination in cleanroom environments, pharmaceutical manufacturing suites, microelectronics fabrication facilities, and controlled research laboratories. It operates on the principle of single-particle light scattering (SPLS) using a long-life 650 nm laser diode as excitation source. When aerosolized particles pass through the focused laser beam within the sensing volume, they generate Mie-scattered photons detected by a high-sensitivity photodiode array. The amplitude and temporal profile of each pulse are processed in real time to classify particles into six discrete size channels: 0.3 µm, 0.5 µm, 1.0 µm, 3.0 µm, 5.0 µm, and 10.0 µm. With a nominal volumetric flow rate of 28.3 L/min — compliant with ISO 21501-4 and aligned with standard cleanroom certification protocols — the instrument delivers statistically robust data suitable for ISO 14644-1 classification, EU GMP Annex 1 verification (both static and dynamic conditions), and USP particulate matter testing in non-sterile preparations.

Key Features

• Integrated 8-inch color TFT-LCD capacitive touchscreen interface (162 mm × 121 mm, 4:3 aspect ratio) enabling intuitive navigation, parameter configuration, and real-time histogram visualization without external PCs.
• AISI 304 stainless steel enclosure meeting stringent surface finish and corrosion resistance requirements for ISO Class 5–8 cleanrooms and GMP-regulated environments.
• High-stability Thomas (Germany) diaphragm vacuum pump ensuring continuous operation at rated flow with low acoustic noise (<45 dB(A)) and minimal electromagnetic interference — critical for use near sensitive analytical instrumentation.
• Dual-mode power architecture: field-deployable operation via integrated 18 Ah lithium-ion battery (rated for ≥4 hours at 28.3 L/min) or continuous mains-powered operation (AC 220 V / 50 Hz) with automatic switchover.
• Onboard thermal printer supporting immediate hardcopy generation of sampling reports including timestamp, location ID, particle counts per channel, calculated ISO class, and operator signature fields.
• Self-cleaning function validated to achieve ≤10-minute recovery to background noise level (three consecutive zero-counts at 95% confidence), ensuring measurement integrity between sequential sampling points.

Sample Compatibility & Compliance

The Y09-310AC-DC is designed exclusively for ambient and process air sampling in non-hazardous, non-explosive atmospheres. It is not rated for use with corrosive gases, condensable vapors, or oil-laden aerosols. Its isokinetic sampling head (included) maintains representative particle transport across the full 0.3–10.0 µm range under laminar flow conditions. All performance specifications comply with national metrological verification regulations JJF 1190–2008 and GB/T 6167–2007, and its size binning accuracy has been verified against NIST-traceable PSL standards. For regulatory submissions, raw data export supports audit-ready formats compatible with 21 CFR Part 11-compliant document management systems when paired with validated third-party software. The device meets mechanical and electrical safety requirements per IEC 61010-1 and environmental operating limits defined in ISO 14644-1 Annex B.

Software & Data Management

Data acquisition, storage, and reporting are managed entirely onboard via embedded firmware supporting up to 5,000 complete sampling records. Each record includes date/time stamp, user-defined location ID, sampling duration and interval, all six-channel cumulative and differential counts, calculated UCL values per ISO 14644-1 Annex D, and pass/fail status against configurable cleanliness thresholds. Export is enabled via USB 2.0 interface to FAT32-formatted USB drives or host PCs; CSV and proprietary .HJC binary formats are supported. Firmware updates are delivered free-of-charge throughout product lifecycle and installed via USB without requiring service intervention. Optional PC-based analysis software (sold separately) provides advanced statistical tools including trend analysis, spatial mapping of contamination gradients, and automated compliance reporting aligned with ISO 14644-2 surveillance requirements.

Applications

• ISO 14644-1 cleanroom certification and routine monitoring in semiconductor fabs, biopharmaceutical fill-finish lines, and aseptic processing isolators.
• GMP Annex 1 environmental monitoring programs for Grade A–D zones, including dynamic operational qualification (OQ) and periodic requalification.
• Validation of HVAC filtration efficiency, laminar airflow hoods (LAFH), and glovebox integrity testing.
• Particulate baseline characterization during facility commissioning and post-maintenance recommissioning.
• Research applications in aerosol science, filtration media testing, and indoor air quality (IAQ) assessment where traceable, portable particle counting is required.

FAQ

What calibration standards does the Y09-310AC-DC conform to?
It is factory-calibrated per GB/T 6167–2007 and JJF 1190–2008, using NIST-traceable polystyrene latex (PSL) spheres. Annual recalibration is recommended per ISO/IEC 17025-accredited laboratories.
Can this unit be used outdoors or in uncontrolled environments?
No. It is intended solely for conditioned indoor spaces with temperature 0–40 °C and relative humidity 10–90% non-condensing. Extended exposure to atmospheric dust or high humidity may compromise sensor longevity and measurement fidelity.
Is the internal battery replaceable by the end user?
Yes — the 18 Ah Li-ion pack is field-replaceable using standard Torx T10 tools; replacement batteries are available directly from HJ with full CE/UN38.3 certification documentation.
Does the device support networked data transmission (e.g., Ethernet or Wi-Fi)?
No. Communication is limited to USB 2.0 host/device mode. Network integration requires external gateway hardware and middleware compliant with MQTT or OPC UA protocols.
How is compliance with FDA 21 CFR Part 11 ensured?
The instrument itself does not implement electronic signatures or audit trails. However, exported CSV files retain immutable timestamps and metadata, enabling integration into validated LIMS or ELN platforms that provide full Part 11 functionality.