Kanomax Model 3888/3889 Handheld Laser Particle Counter

Overview

The Kanomax Model 3888 and 3889 are portable, ISO 21501-4–compliant laser diode-based airborne particle counters engineered for high-fidelity monitoring of cleanroom environments in pharmaceutical manufacturing, microelectronics fabrication, aseptic processing, and biomedical research laboratories. These instruments operate on the principle of single-particle light scattering: aerosol samples are drawn through a precisely controlled laminar flow path at 2.83 L/min (0.1 cfm), where particles passing through a focused laser beam generate scattered light pulses proportional to their size. Signal processing electronics classify each pulse into one of six user-selectable channels—0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm—enabling simultaneous real-time counting and size-resolved concentration reporting in units of particles per cubic foot (pc/ft³) or particles per cubic meter (pc/m³). Designed for compliance with ISO 14644-1, GB/T 16292–2010, and China’s revised Good Manufacturing Practice (GMP) Annex 1 requirements, the 3888/3889 series supports qualification, routine surveillance, and deviation investigation in Grade A–D clean zones.

Key Features

• Compact handheld form factor (102 × 56 × 215 mm; ~650 g) with ergonomic grip and integrated rechargeable lithium-ion battery (2 × 3.7 V / 2600 mAh), enabling up to 5 hours of continuous operation per charge
• 4.3-inch true-color capacitive touchscreen interface supporting four operational languages: English, Japanese, Simplified Chinese, and Spanish
• Dual USB ports (Host and Device) on main unit; optional docking station provides RS-485, Ethernet, and Wi-Fi connectivity for remote control, data streaming, and networked multi-point monitoring
• Configurable sampling protocols: single-shot, repeated, continuous, calculated (e.g., average over N cycles), ISO-compliant, or GB/T-aligned test modes
• Onboard storage capacity of 10,000 measurement records in CSV format, including timestamp, location ID, operator tag, and full six-channel count distribution per sample
• Integrated statistical engine supporting mean, standard deviation, coefficient of variation (CV%), and pass/fail evaluation against user-defined limits per ISO 14644-1 classification tables

Sample Compatibility & Compliance

The 3888/3889 is validated for use with ambient air, compressed gases (via optional isokinetic probe), and filtered process air streams across temperature ranges of 10–40 °C and relative humidity up to 85% RH (non-condensing). It meets optical calibration traceability requirements per ISO 21501-4 and JIS B 9921 for particle sizing accuracy and counting efficiency. The instrument’s counting performance has been verified against reference aerosols (e.g., PSL spheres) across its full dynamic range (up to 2 × 10⁶ particles/ft³). Regulatory alignment includes full support for FDA 21 CFR Part 11–compliant audit trails when used with Kanomax’s certified PC software and docking station, as well as GLP/GMP documentation workflows required for EU Annex 1 and PIC/S inspections.

Software & Data Management

Kanomax’s proprietary PC application enables bidirectional communication via USB or Wi-Fi. Users can configure instrument parameters remotely—including sampling duration (6 sec to 99 min 59 sec), cycle count (1–999), alarm thresholds, and channel selection—while viewing live histograms and time-series plots of all six size bins. All exported CSV files include metadata fields compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Optional integration with LIMS or MES platforms is supported through ASCII-based serial command sets over RS-485 or HTTP API endpoints via Ethernet/Wi-Fi. Firmware updates and configuration templates are distributed through Kanomax’s secure customer portal.

Applications

• ISO 14644-1 cleanroom certification and periodic requalification (e.g., airborne particle testing in Grade A laminar flow hoods, Grade B background areas)
• GMP Annex 1 compliance verification for sterile product manufacturing environments
• Filter integrity validation and leak detection in HEPA/ULPA systems
• Process equipment qualification (e.g., isolators, RABS, filling lines)
• Environmental monitoring during aseptic media fills and simulation studies
• Contamination source tracing and root cause analysis in microelectronics cleanrooms
• Real-time feedback during critical operations such as lyophilizer loading or vial capping

FAQ

What standards does the Kanomax 3888/3889 comply with?
It complies with ISO 21501-4 (calibration and performance), ISO 14644-1 (cleanroom classification), JIS B 9921 (Japanese national standard), and GB/T 16292–2010 (Chinese pharmaceutical cleanroom standard), and supports GMP Annex 1 documentation requirements.
Can the instrument measure temperature and relative humidity?
Not natively—the base unit lacks built-in environmental sensors. However, optional Kanomax Model 0842 temperature/humidity probes (±0.5 °C, ±3% RH in 30–80% RH range) connect directly to the instrument’s auxiliary port for synchronized environmental logging.
How is data security and traceability ensured?
When operated with the docked station and validated software, the system supports electronic signatures, immutable audit trails, and user access controls aligned with 21 CFR Part 11 and EU GMP Annex 11 expectations.
What is the maximum particle concentration it can accurately resolve?
The upper limit is 2,000,000 particles per cubic foot (≈7.1 × 10⁷ particles/m³) with maintained counting efficiency and coincidence error correction enabled.
Is firmware update capability available in the field?
Yes—updates are delivered via USB flash drive or over-the-air (Wi-Fi) using signed binaries distributed exclusively through Kanomax’s authorized support channels.