Kanomax Model 3905 High-Flow Laser Particle Counter for Cleanroom Monitoring

Overview

The Kanomax Model 3905 is a high-precision, portable laser particle counter engineered for real-time airborne particulate monitoring in critical controlled environments. Based on the principle of light scattering from a stabilized 650 nm laser diode source, it delivers traceable, repeatable quantification of suspended particles across six discrete size channels—0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm—in a single 28.3 L/min volumetric sample draw. Its optical design adheres strictly to ISO 21501-4:2018 for calibration validity, ensuring metrological traceability to national standards. The instrument is purpose-built for ISO Class 3–8 cleanrooms (per ISO 14644-1:2015), pharmaceutical aseptic processing areas, semiconductor fabrication tools, and biomedical device manufacturing suites where regulatory-grade data integrity is non-negotiable.

Key Features

• High-flow sampling at 28.3 L/min (1 ft³/min), enabling statistically robust concentration measurements per ISO 14644-1 sampling plan requirements
• Simultaneous six-channel detection with calibrated counting efficiency per ISO 21501-4: 50 ± 20% at 0.3 µm and ≥98% at ≥0.5 µm
• Integrated 6.4-inch capacitive touchscreen interface with intuitive menu navigation, multilingual support (English & Chinese), and real-time histogram visualization
• Built-in thermal printer for immediate hardcopy generation of compliance-ready reports—including pass/fail evaluation against ISO 14644-1 limits
• Dual rechargeable Li-ion battery system (hot-swappable) supporting >4 hours continuous operation; AC adapter included for lab or fixed-location use
• Onboard data storage for up to 10,000 timestamped measurement records, each containing full channel counts, sampling duration, location ID, operator tag, and environmental metadata
• USB 2.0 and Ethernet interfaces for secure data export, remote configuration, and networked fleet management via Kanomax’s PC-based analysis software

Sample Compatibility & Compliance

The Model 3905 is validated for use with standard isokinetic sampling probes and conductive polyurethane tubing (2 m supplied). It supports optional external sensors—including NIST-traceable temperature/humidity, differential pressure, and hot-wire anemometer modules—for concurrent environmental parameter logging. All particle count outputs comply with ISO 14644-1:2015 Annex B statistical protocols and are directly interpretable against EU GMP Annex 1, FDA Aseptic Processing Guidance, and JPAL Standard JIS B 9921. Instrument firmware implements full 21 CFR Part 11 compliance: electronic signatures, role-based access control, immutable audit trails, and automatic data backup upon power cycle or memory full condition.

Software & Data Management

Kanomax’s proprietary CleanRoom Manager™ software (Windows-compatible) enables post-acquisition analysis, spatial mapping (via user-defined grid coordinates), trending over time, and automated report generation in PDF or Excel formats. Each exported dataset includes embedded metadata: instrument serial number, calibration certificate expiry date, operator ID, GPS-tagged location (when enabled), and full chain-of-custody logs. Raw binary files are encrypted and digitally signed to satisfy GLP/GMP data integrity requirements. U盘 (USB flash drive) import/export preserves folder hierarchy and file timestamps, facilitating seamless integration into LIMS or MES platforms.

Applications

• Verification and routine monitoring of ISO Class 3–8 cleanrooms per ISO 14644-2:2015 periodic testing schedules
• HEPA/ULPA filter leak testing using scanning probe mode with positional encoding (0–999 map points)
• Environmental qualification of isolators, RABS, and laminar flow hoods in pharmaceutical manufacturing
• Contamination control audits in semiconductor photolithography bays and MEMS packaging lines
• Validation of HVAC performance during commissioning and recommissioning of life science facilities
• Real-time feedback during aseptic gowning procedures and surgical suite readiness assessments

FAQ

Does the Model 3905 meet FDA 21 CFR Part 11 requirements for electronic records?
Yes—firmware v3.2+ includes full Part 11 functionality: electronic signatures, audit trail with tamper-proof timestamps, and role-based user authentication.
Can I customize the six detectable particle size thresholds?
Yes—while factory-default channels are 0.3/0.5/1.0/3.0/5.0/10.0 µm, the instrument allows user-defined binning within 0.3–10.0 µm range, subject to ISO 21501-4 resolution constraints.
Is calibration traceable to national standards?
All units ship with a NIST-traceable calibration certificate issued by Kanomax Japan Calibration Center, valid for 12 months under normal operating conditions.
What is the maximum allowable particle concentration before coincidence loss exceeds 10%?
Per ISO 21501-4, the upper limit is 500,000 particles/ft³ (17.6 × 10⁶ particles/m³) at 28.3 L/min flow; built-in coincidence correction algorithms apply above 150,000 particles/ft³.
Does the internal printer support regulatory-compliant report headers?
Yes—the printed output includes instrument ID, calibration due date, test location, operator name, ISO class designation, and pass/fail conclusion per selected standard (e.g., ISO 14644-1 Table 1).