Kanomax 3888 Handheld Laser Particle Counter

Overview

The Kanomax 3888 Handheld Laser Particle Counter is an ISO 21501-4–compliant optical particle counter engineered for high-fidelity airborne particulate monitoring in regulated and non-regulated environments. Utilizing a stable 650 nm laser diode light source and precise Mie scattering detection, the instrument simultaneously quantifies six discrete particle size channels—0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm—with a calibrated volumetric flow rate of 2.83 L/min (0.1 cfm). Its design prioritizes metrological integrity: flow stability is maintained within ±1 particle deviation over 5-minute intervals, while timing accuracy remains within ±1 second during standard 6-minute sampling cycles—critical for ISO 14644-1 classification audits and GMP environmental monitoring. The device operates on dual high-capacity lithium-ion batteries, enabling up to five hours of continuous field operation without external power, and supports real-time data acquisition under dynamic environmental conditions (10–40 °C, 0–85% RH, non-condensing).

Key Features

• Simultaneous six-channel particle sizing (0.3–10.0 µm) with ISO 21501-4–validated counting efficiency
• 4.3-inch true-color capacitive touchscreen with intuitive UI supporting English, Japanese, Chinese, and Spanish language modes
• Dual USB interfaces (Host and Device) plus optional base-mounted RS-485, Ethernet, and Wi-Fi connectivity for flexible integration into facility monitoring networks
• Onboard storage for 10,000 measurement records in CSV format, including timestamped channel-specific counts, sampling duration, and environmental metadata
• Configurable sampling protocols: single-shot, repeated, continuous, calculated (e.g., cumulative, differential), ISO-compliant, and GB/T 16292-2010–aligned test sequences
• Integrated alarm system with user-defined upper limits across any particle channel (1–9,999,999 counts)
• Robust mechanical architecture: IP52-rated enclosure, shock-absorbing housing, and compact form factor (102 × 56 × 215 mm; ~650 g) optimized for handheld use in cleanrooms, isolators, and production lines

Sample Compatibility & Compliance

The Kanomax 3888 is validated for use in ISO Class 5–8 cleanrooms, pharmaceutical manufacturing suites, medical device assembly areas, and semiconductor fabrication support zones. It meets the performance requirements of ISO 21501-4 (Calibration and verification of airborne particle counters), JIS B9921 (Japanese Industrial Standard for particle counters), and GB/T 16292-2010 (Chinese national standard for cleanroom testing). Its measurement traceability aligns with ISO 14644-1:2015 classification procedures and satisfies data integrity expectations under China’s 2010 Good Manufacturing Practice (GMP) regulations for sterile product facilities. When paired with the optional Kanomax 0842 temperature/humidity probe (±0.5 °C, ±3% RH in 30–80% RH range), environmental context is automatically appended to each particle record—supporting root-cause analysis during excursion investigations.

Software & Data Management

Kanomax’s proprietary PC software enables bidirectional communication via USB or networked base station. Users can remotely configure sampling parameters—including duration (6 sec–99 min 59 sec), frequency (1–999 cycles or continuous), and alarm thresholds—while viewing real-time particle concentration trends across all six size bins. All exported CSV files include column headers compliant with ASTM E29-23 formatting conventions, facilitating import into LIMS, statistical process control (SPC) platforms, or audit-ready reporting tools. Audit trail functionality (including operator ID, parameter changes, and firmware version stamps) supports compliance with FDA 21 CFR Part 11 when deployed in validated environments. Data export options include direct USB transfer, Wi-Fi upload to shared network drives, and automated scheduled backups.

Applications

• ISO 14644-1 cleanroom certification and routine monitoring (e.g., point-of-use testing at critical process locations)
• GMP Annex 1 and EU GMP Chapter 5 environmental qualification of aseptic processing zones
• Filter integrity verification and leak detection in HEPA/ULPA systems
• In-process monitoring of powder handling, lyophilization, and filling operations
• Validation of laminar airflow workstations, biosafety cabinets, and isolators
• Baseline characterization and trending of ambient particulate levels in R&D laboratories and microelectronics fabrication support areas

FAQ

What calibration standards does the Kanomax 3888 comply with?
It adheres to ISO 21501-4 for optical calibration, JIS B9921 for Japanese market validation, and GB/T 16292-2010 for domestic Chinese regulatory acceptance.
Can the instrument operate continuously during battery-powered use?
Yes—up to 5 hours of uninterrupted sampling in single-test mode; runtime scales inversely with sampling frequency and display brightness settings.
Is remote firmware update supported?
Firmware updates are performed via USB-connected PC using Kanomax’s official software; network-based OTA updates are not implemented.
Does the device meet FDA 21 CFR Part 11 requirements for electronic records?
When used with configured audit trails, time-stamped operator logs, and secure CSV export protocols, it supports Part 11 compliance within a validated system framework—but final validation responsibility rests with the end-user’s QA department.
What is the maximum particle concentration the 3888 can accurately measure?
The upper limit is 2,000,000 particles per cubic foot (≈70.8 million/m³); concentrations above this threshold require dilution or alternative instrumentation to avoid coincidence error.