Kanomax 3889 Handheld Laser Particle Counter
| Brand | Kanomax |
|---|---|
| Origin | Japan |
| Model | KANOMAX 3889 |
| Instrument Type | Handheld |
| Flow Rate | 2.83 L/min |
| Flow Accuracy | < ±1 particle/5 min |
| Timing Accuracy | < ±1 s over 6-min sampling |
| Repeatability | ≤ ±10% FS |
| Size Distribution Error | ≤ ±30% |
| Indication Error | ≤ ±30% FS |
| Particle Channels | 0.3, 0.5, 1.0, 3.0, 5.0, 10.0 µm |
| Display | 4.3-inch full-color TFT touchscreen |
| Language Support | English, Chinese, Japanese, Spanish |
| Data Storage | Internal high-capacity memory with statistical analysis |
| Connectivity | USB and Wi-Fi |
| Compliance | ISO 21501-4, ISO 14644-1, GB/T 16292–2010, China GMP (2010) Annex 1 |
| Environmental Sensors | Optional external temperature & relative humidity probes |
Overview
The Kanomax 3889 Handheld Laser Particle Counter is an ISO 21501-4 compliant optical particle counter engineered for high-fidelity airborne particulate monitoring in controlled environments. Utilizing a calibrated 635 nm semiconductor laser diode and a high-efficiency condensation-free optical detection system, the instrument employs light scattering principles to detect and size particles across six discrete channels: 0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm. With a certified volumetric flow rate of 2.83 L/min (0.1 ft³/min), it meets the minimum sampling requirement for ISO Class 5 cleanroom certification per ISO 14644-1 and aligns with the procedural rigor mandated by pharmaceutical cleanroom validation under China’s 2010 GMP Annex 1 and USP . Its compact, ergonomic form factor enables rapid point-of-use verification during HVAC commissioning, filter integrity testing, and routine environmental monitoring in cleanrooms, isolators, and laminar flow hoods.
Key Features
- ISO 21501-4–certified optical sensing architecture with dual-stage signal processing for improved pulse discrimination and reduced coincidence error
- High-stability diaphragm sampling pump ensuring consistent 2.83 L/min flow under variable backpressure conditions typical in ducted or probe-based sampling
- 4.3-inch full-color resistive touchscreen with anti-glare coating, supporting glove-compatible operation and real-time channel-specific concentration display
- Multi-language UI (English, Chinese, Japanese, Spanish) with context-aware menu navigation and intuitive test method selection
- Onboard data storage capable of retaining >10,000 sample records with timestamp, location tag, operator ID, and full channel distribution histograms
- Dual communication interface: USB 2.0 for direct PC synchronization and Wi-Fi 802.11 b/g/n for secure enterprise network integration and remote configuration via web-based management console
- Optional analog/digital input support for external temperature and relative humidity sensors—enabling concurrent environmental parameter logging per ISO 14644-2 Annex B requirements
Sample Compatibility & Compliance
The Kanomax 3889 is validated for use in non-hazardous, non-corrosive ambient air and compressed air systems (with appropriate inlet conditioning). It is not intended for oil mist, solvent vapor, or high-humidity (>95% RH) environments without optional desiccant pre-filters. All calibration and performance verification procedures follow traceable NIST-traceable reference aerosols (e.g., PSL spheres) and are documented per ISO/IEC 17025–accredited laboratory protocols. The device satisfies mandatory reporting formats defined in GB/T 16292–2010 (Chinese pharmaceutical cleanroom standard), ISO 14644-1:2015 (cleanroom classification), and EU GMP Annex 1 (2022 revision) for viable and non-viable particle monitoring. Audit-ready data export includes CSV and PDF report generation with embedded digital signatures compatible with 21 CFR Part 11–compliant workflow systems.
Software & Data Management
The included Kanomax Data Manager software (Windows 10/11 compatible) provides full traceability through automated audit trails, user permission levels, and electronic signature capture. Raw count data is stored with immutable metadata—including GPS coordinates (when enabled), battery voltage, pump status, and ambient sensor readings. Statistical functions include moving average trend analysis, UCL (Upper Control Limit) calculation per ISO 14644-2, and pass/fail flagging against configurable alert thresholds. Data exports support LIMS integration via HL7 or ASTM E1384-compliant XML schema. Firmware updates are delivered over-the-air via Wi-Fi, with version rollback capability and SHA-256 checksum verification.
Applications
- Pharmaceutical manufacturing: Aseptic processing line qualification, isolator performance verification, and Grade A/B/C/D area monitoring per EU and FDA guidance
- Semiconductor fabrication: Cleanroom classification audits, tool chamber particle baseline establishment, and post-maintenance recovery validation
- Medical device packaging: ISO 11140-5 compliance verification for sterile barrier systems
- Research laboratories: Aerosol generation characterization, filtration efficiency testing (per ISO 16890), and HVAC airflow pattern analysis
- Healthcare facilities: Operating room air quality surveillance and negative pressure isolation room verification
FAQ
Does the Kanomax 3889 comply with FDA 21 CFR Part 11 requirements for electronic records?
Yes—when used with Kanomax Data Manager v3.2+ and configured with role-based access control, electronic signatures, and audit trail logging, the system supports Part 11 compliance for regulated environments.
Can the instrument be calibrated in-house using standard PSL particles?
No—calibration must be performed by an ISO/IEC 17025–accredited service center using NIST-traceable reference materials; field verification with check aerosols is permitted between calibrations.
Is the 0.3 µm channel verified per ISO 21501-4 sensitivity requirements?
Yes—the optical system achieves ≥50% counting efficiency at 0.3 µm with ≤30% sizing error, as confirmed in the manufacturer’s type-test report (Report No. KMX-TC-3889-2022-041).
