HJ Y09-5100 Laser Particle Counter

Overview

The HJ Y09-5100 Laser Particle Counter is a high-precision, portable laboratory-grade instrument engineered for real-time quantification of airborne particulate contamination in controlled environments. It operates on the principle of single-particle light scattering: a collimated 650 nm laser diode illuminates aerosolized particles drawn through a precisely defined sensing volume at 100 L/min; scattered photons are detected by a high-sensitivity photodiode array and classified into six discrete size channels (0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm). The device meets the optical and fluidic performance requirements specified in ISO 21501-4 for light-scattering airborne particle counters and is validated per national metrological standards GB/T 6167–2007 and JJF 1190–2008. Its design prioritizes regulatory readiness—SUS304 stainless-steel enclosure ensures corrosion resistance and cleanability, while its sealed internal architecture minimizes internal shedding and supports GMP-compliant operation in Grade A/B/C/D cleanrooms.

Key Features

• 100 L/min high-flow sampling with ≤±5% volumetric accuracy, enabling statistically robust data acquisition per ISO 14644-1 sampling plans for large-volume cleanrooms and isolators
• 8-inch full-color TFT-LCD capacitive touchscreen (162 × 121 mm, 4:3 aspect ratio) with intuitive GUI supporting multi-language interface, parameter configuration, and real-time histogram visualization
• Integrated high-efficiency brushless diaphragm pump delivering stable airflow under variable backpressure, with noise emission <45 dB(A) and low EMI signature suitable for electromagnetic-sensitive labs
• Dual-power architecture: field-replaceable 18650 lithium-ion battery pack (16.8 V, nominal 5,000 mAh) enables up to 5 hours of continuous operation; AC adapter input (100–240 VAC, 50/60 Hz) provides seamless charging and mains-powered use
• Onboard thermal printer with auto-cut function for immediate hard-copy generation of sample reports including timestamp, location ID, particle counts per channel, and pass/fail status against ISO or GMP thresholds
• Self-cleaning capability verified to ≤10 minutes (95% confidence level), achieved via integrated HEPA-filtered purge air path that eliminates residual particles from the optical chamber between samples

Sample Compatibility & Compliance

The Y09-5100 is designed exclusively for ambient and compressed gas-phase sampling in non-hazardous, non-explosive environments. It accommodates standard isokinetic sampling probes (included: stainless-steel isokinetic inlet, flexible conductive tubing, tripod mount) and interfaces directly with laminar flow hoods, gloveboxes, and HVAC ducts via optional adapters. All firmware and hardware configurations support audit-ready data integrity: timestamps are hardware-synchronized, memory logs retain full metadata (operator ID, location tag, calibration due date), and exported CSV/USB files include digital signatures compatible with 21 CFR Part 11-compliant review workflows. The instrument conforms to ISO 14644-1:2015 for cleanroom classification, EU GMP Annex 1 (2022) for sterile manufacturing monitoring, and USP for pharmaceutical particulate testing in non-sterile environments.

Software & Data Management

Data capture is managed via embedded firmware supporting user-defined sampling protocols—including programmable duration (5–9999 s), delay intervals (1–100 s), and sequential point mapping (2–50 locations). Up to 5,000 complete measurement records are stored internally with full traceability: each entry includes raw channel counts, calculated concentrations (particles/m³), environmental conditions (if optional温湿度 probe is installed), and UCL (Upper Confidence Limit) analysis per ISO 14644-1 Annex D. USB 2.0 host port allows direct export to PC or external storage; included PC software (Windows-compatible) enables batch report generation, trend charting, deviation flagging, and PDF export compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

Applications

• Validation and routine monitoring of ISO Class 3–8 cleanrooms and critical process environments in biopharmaceutical, medical device, and semiconductor manufacturing
• In-process verification of filter integrity (HEPA/ULPA) via upstream/downstream challenge testing and leak scanning per IEST-RP-CC034.2
• Environmental monitoring (EM) programs supporting EU GMP Annex 1 compliance for aseptic processing suites and isolator systems
• Compressed air quality assessment per ISO 8573-1:2010 Class 2–4 particulate specifications
• Research-grade aerosol characterization in university cleanroom labs, nanomaterial handling facilities, and HVAC performance studies

FAQ

What calibration standards does the Y09-5100 comply with?
It is factory-calibrated using NIST-traceable PSL (polystyrene latex) spheres and certified per GB/T 6167–2007 and JJF 1190–2008. Optional annual recalibration services include ISO 21501-4 verification and certificate issuance.
Can the instrument be used outdoors or in uncontrolled environments?
No. It is intended solely for indoor, climate-controlled environments (0–40 °C, 10–90% RH). Prolonged exposure to ambient air may contaminate the optical sensor and invalidate measurements.
Is the data output compliant with FDA 21 CFR Part 11?
Yes—when used with enabled audit trail logging, electronic signatures, and secure USB export protocols, the system satisfies core Part 11 requirements for electronic records and signatures in regulated GxP environments.
Does the Y09-5100 support remote monitoring or network integration?
Not natively. It lacks Ethernet/Wi-Fi modules; however, periodic USB data extraction and ingestion into centralized LIMS or MES platforms is fully supported via standardized CSV schema.
What is the recommended maintenance schedule?
Optical chamber cleaning every 6 months (or after 500 hours of operation); pump filter replacement every 12 months; full system verification annually or after any physical impact or sensor anomaly.