Kanomax 3920 High-Flow Airborne Particle Counter (100 L/min)

Overview

The Kanomax 3920 is a high-precision, portable airborne particle counter engineered for rapid and reliable classification and monitoring of cleanroom environments in regulated industries. Operating on the principle of light scattering—where particles suspended in sampled air pass through a focused laser beam and generate scattered photons detected by a high-sensitivity photodiode—the instrument delivers real-time, multi-channel particle concentration data at a nominal volumetric flow rate of 100 L/min. This high-flow capability enables statistically robust sampling in accordance with ISO 14644-1:2015 minimum sample volume requirements for Class 3–5 cleanrooms, significantly reducing test duration compared to conventional 28.3 L/min or 50 L/min instruments. The device employs a temperature-stabilized 650 nm laser diode and an optimized optical cavity designed to minimize coincidence loss and maintain counting efficiency across its six user-selectable size channels (0.5, 0.7, 1.0, 3.0, 5.0, and 10.0 µm), all calibrated per ISO 21501-4. Its compact, stainless-steel chassis (200 × 205 × 250 mm), dual hot-swappable Li-ion battery system, and ergonomic handle support extended field operation without AC dependency.

Key Features

• High-flow sampling at 100 L/min with flow stability maintained within ±1 particle deviation over 5-minute intervals—critical for low-concentration detection and rapid compliance verification.
• Six independent particle size channels programmable to standard or custom thresholds (0.5–10.0 µm range), enabling simultaneous monitoring aligned with ISO 14644-1, EU GMP Annex 1, and USP reporting requirements.
• Integrated thermal printer supporting on-the-spot hardcopy generation of test reports with timestamp, location map code, and operator ID—fully traceable and audit-ready.
• True-color 6.4-inch capacitive touchscreen interface with intuitive navigation, bilingual (English/Chinese) display, and configurable test modes: single-shot, timed interval, continuous logging, and statistical summary.
• Robust data integrity architecture compliant with FDA 21 CFR Part 11: electronic signatures, audit trails, user-level access control (admin/operator/guest), and encrypted local storage of up to 10,000 measurement files.
• Expandable sensor integration via RS-485 and analog inputs—supports concurrent acquisition of temperature, relative humidity, differential pressure, and air velocity using optional certified environmental probes.

Sample Compatibility & Compliance

The Kanomax 3920 is validated for use in non-hazardous, non-corrosive indoor air environments across pharmaceutical manufacturing suites, aseptic processing isolators, semiconductor fabrication clean zones, hospital operating theatres, and aerospace assembly facilities. It meets the metrological performance criteria defined in ISO 21501-4 for light-scattering airborne particle counters—including counting efficiency, size resolution, false count rate (<0.2 particles/ft³), and zero-count stability per JIS B 9921. Regulatory alignment extends to ISO 14644-1:2015 (cleanroom classification), ISO 14644-2:2015 (monitoring requirements), EU GMP Annex 1 (2022 revision), USP (particulate matter in injections), and China’s GB/T 16292–2010 and GB 50333–2013 standards. All factory calibrations are traceable to NMIJ (National Metrology Institute of Japan) reference aerosols.

Software & Data Management

Data export and remote supervision are supported via Ethernet (TCP/IP) and USB 2.0 interfaces. The included Kanomax Data Manager software (Windows-compatible) enables batch analysis, trend visualization, ISO UCL (Upper Confidence Limit) calculation per ISO 14644-1 Annex D, and automated report generation in PDF or CSV formats. Audit trail logs record all user actions—including parameter changes, calibration events, and data deletions—with timestamps and operator identifiers. Optional cloud synchronization allows centralized fleet management for multi-site QA/QC operations under GLP/GMP frameworks. Data integrity safeguards include write-protection modes, checksum validation, and tamper-evident file encryption compliant with 21 CFR Part 11 Subpart C.

Applications

• Cleanroom certification and routine monitoring per ISO 14644-1 occupancy states (as-built, at-rest, operational).
• HEPA/ULPA filter integrity testing via upstream challenge and downstream scanning with iso-kinetic probe attachment.
• Aseptic process simulation (media fill) environmental monitoring during critical interventions.
• Particle shedding assessment of gowning materials, packaging components, and tooling surfaces.
• Baseline characterization and qualification of laminar airflow workbenches, isolators, and RABS systems.
• Investigation of contamination excursions through time-resolved spatial mapping using integrated map-code tagging.

FAQ

What regulatory standards does the Kanomax 3920 formally comply with?

It is type-approved to ISO 21501-4 for photometric performance and fully supports compliance workflows for ISO 14644-1, EU GMP Annex 1, USP , FDA 21 CFR Part 11, and GB/T 16292–2010.
Can the instrument perform real-time statistical analysis during sampling?

Yes—it calculates and displays running averages, standard deviations, and upper confidence limits (UCL) per ISO 14644-1 Annex D in real time during continuous or interval mode.
Is external environmental sensor data synchronized with particle counts?

Absolutely. When connected to optional Kanomax environmental probes (e.g., model 3887 for temp/RH/pressure), all parameters are time-aligned and stored in a single composite dataset.
How is data security enforced for Part 11 compliance?

Through role-based authentication, electronic signature capture, immutable audit trails, and encrypted local storage—all validated per Part 11 Subpart C technical controls.
What is the recommended recalibration interval?

Annual recalibration is advised; however, the built-in zero-count verification and flow check routines permit daily operational verification without external equipment.