Kanomax 3887D Handheld Laser Particle Counter
| Brand | Kanomax |
|---|---|
| Origin | Japan |
| Model | 3887D |
| Instrument Type | Handheld |
| Flow Rate | 2.83 L/min |
| Flow Accuracy | <1 particle/5 min |
| Timing Accuracy | ±1 s within 6-min sampling |
| Repeatability | ≤±10% FS |
| Size Distribution Error | ≤±30% |
| Indication Error | ≤±30% FS |
| Particle Size Channels | 0.3, 0.5, 1.0, 3.0, 5.0 µm (selectable) |
| Compliance | GB/T 16292–2010, ISO 14644-1, China GMP (2010) |
| Data Storage | High-capacity internal memory with statistical analysis |
| Power Management | Auto-save on power interruption |
| Display | Backlit Chinese-language interface |
| Sampling Delay | Programmable to minimize operator-induced contamination |
Overview
The Kanomax 3887D Handheld Laser Particle Counter is an optically engineered instrument designed for real-time, quantitative monitoring of airborne particulate contamination in cleanroom environments, pharmaceutical manufacturing facilities, hospital isolation rooms, and controlled laboratory spaces. It operates on the principle of single-particle light scattering—where aerosolized particles pass through a focused laser beam, generating scattered light pulses proportional to their size and concentration. These pulses are detected by a high-sensitivity photodiode array and classified into five user-selectable size channels (0.3, 0.5, 1.0, 3.0, and 5.0 µm), enabling compliance-aligned reporting per ISO 14644-1:2015, GB/T 16292–2010, and China’s Good Manufacturing Practice (GMP) Annex 1 (2010 edition). As a direct evolution of the Kanomax 3886 platform, the 3887D integrates enhanced firmware stability, programmable sampling logic, and localized human-machine interaction—without compromising metrological integrity or mechanical robustness.
Key Features
- Compact handheld architecture optimized for ergonomic field operation and rapid point-of-use verification.
- Fixed volumetric flow rate of 2.83 L/min, maintained via precision-calibrated axial fan and laminar flow conditioning—ensuring consistent sample draw across variable ambient pressure and temperature conditions.
- Programmable pre-sampling delay (0–600 seconds) to eliminate transient operator-induced disturbances before data acquisition begins.
- Backlit monochrome LCD with full Chinese-language menu navigation—reducing training overhead and minimizing input error in multilingual operational settings.
- Internal non-volatile memory supporting ≥10,000 sample records with timestamp, location tag, and channel-specific cumulative counts.
- Automatic power-fail recovery: all unsaved data and active test parameters are retained during unexpected shutdowns, resuming measurement upon restart without loss of continuity.
- Integrated statistical engine calculating mean, standard deviation, and 95% UCL (Upper Confidence Limit) per ISO 14644-1 Annex B—enabling immediate qualification assessment against class limits.
Sample Compatibility & Compliance
The 3887D is validated for use with ambient air, compressed gases (with optional desiccant filtration), and HEPA-filtered supply streams typical of ISO Class 5–8 cleanrooms. Its optical detection system exhibits minimal coincidence error below 1×10⁶ particles/m³ and maintains linearity across its specified dynamic range. All calibration traceability originates from NIST-traceable polystyrene latex (PSL) standards, verified annually per Kanomax’s factory service protocol. The device meets electromagnetic compatibility (EMC) requirements under IEC 61326-1 and safety compliance per IEC 61010-1. Data output formats support audit-ready export (CSV/USB) compatible with 21 CFR Part 11–compliant systems when integrated with validated third-party software platforms.
Software & Data Management
Raw measurement data—including time-stamped channel counts, flow status flags, and battery voltage logs—are stored internally and transferable via USB 2.0 to Windows-based workstations. Kanomax-supplied PC software (Kanomax Data Manager v3.x) enables batch report generation, spatial mapping (via manual location tagging), trend analysis over time-series datasets, and automated UCL calculation per ISO 14644-1 Table D.1. Audit trail functionality includes operator ID logging, parameter change history, and electronic signature fields—supporting GLP/GMP documentation workflows when deployed in regulated QC/QA environments.
Applications
- Periodic certification and requalification of cleanrooms and laminar flow hoods per ISO 14644-2.
- In-process environmental monitoring during aseptic drug filling, lyophilization, and sterile packaging operations.
- Verification of HVAC filter integrity and airflow uniformity testing.
- Baseline particulate profiling in R&D laboratories handling nanomaterials or sensitive optical components.
- Compliance support for FDA, NMPA, and EMA inspections requiring documented evidence of environmental control.
FAQ
What particle size channels does the 3887D support?
It provides five fixed-size detection thresholds: 0.3 µm, 0.5 µm, 1.0 µm, 3.0 µm, and 5.0 µm—user-selectable per measurement session.
Is the flow rate adjustable?
No—the 3887D operates exclusively at a calibrated 2.83 L/min flow rate to ensure consistency with ISO 21501-4 and GB/T 16292 sampling protocols.
Can the device be used in compressed air lines?
Yes, provided upstream moisture and oil removal is performed using appropriate coalescing and desiccant filters to prevent optical contamination or sensor damage.
Does it meet FDA 21 CFR Part 11 requirements?
The hardware itself is not Part 11–certified; however, its data export structure and integration with validated third-party software enable compliant electronic record management in regulated environments.
How often does it require recalibration?
Annual recalibration against PSL reference standards is recommended, with intermediate verification using zero-count air and known concentration challenge aerosols per ISO 21501-4 Clause 8.3.
