Kanomax 3910 High-Flow Airborne Particle Counter (50 L/min)

Overview

The Kanomax 3910 is a high-flow airborne particle counter engineered for rapid, quantitative assessment of particulate contamination in cleanroom environments and controlled manufacturing spaces. Utilizing a calibrated laser diode light source and optimized optical sensing geometry, the instrument operates on the principle of single-particle light scattering—where individual particles passing through a focused laser beam generate transient pulses proportional to their size and refractive index. With a nominal volumetric flow rate of 50 L/min, the 3910 achieves statistically robust sampling in significantly reduced time compared to conventional 28.3 L/min instruments—enabling full ISO 14644-1 class verification in fewer measurement points and shorter dwell times. Its six-channel simultaneous detection capability covers the standard regulatory sizing range (0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm), supporting classification against ISO Class 3 through ISO Class 9, as well as EU GMP Grade A–D and USP requirements. Designed for laboratory and field use, the 3910 integrates metrological traceability to national standards and conforms to ISO 21501-4 for calibration validation, ensuring inter-laboratory comparability and regulatory acceptability.

Key Features

• High-flow sampling at 50 L/min with flow stability maintained within ±1 particle deviation per 5-minute interval—critical for minimizing statistical uncertainty in low-concentration environments.
• Six independent particle size channels configurable to standard or user-defined thresholds across 0.3–10.0 µm, enabling compliance with both legacy and updated cleanroom specifications.
• True-color 6.4-inch capacitive touchscreen interface with intuitive navigation, real-time histogram visualization, and on-device pass/fail evaluation against ISO 14644-1 limits.
• Built-in thermal printer for immediate hard-copy reporting—including timestamp, location ID, operator ID, and full particle count distribution per sampling point.
• Dual hot-swappable rechargeable Li-ion batteries providing >4 hours continuous operation; AC adapter included for benchtop or fixed-location deployment.
• Comprehensive I/O architecture: Ethernet (for networked data logging and remote configuration), USB host port (for firmware updates and U-disk data export), and dedicated analog/digital interfaces for optional environmental sensors.
• Ruggedized aluminum-magnesium alloy chassis (200 × 205 × 250 mm), weighing only 5.0 kg (without battery), certified to IP54 for dust resistance and incidental moisture exposure.

Sample Compatibility & Compliance

The Kanomax 3910 is validated for use in non-hazardous, non-corrosive ambient air and compressed gas streams (with appropriate inlet conditioning). It supports isokinetic sampling via included 2-meter conductive tubing and dynamic probe, minimizing particle loss due to inertial impaction or diffusion. All performance specifications—including counting efficiency, size resolution, false count rate, and zero-count stability—meet or exceed the requirements of ISO 21501-4:2018. The device satisfies mandatory calibration and verification protocols outlined in JJF 1190–2008 (China), GB/T 16292–2010 (Chinese pharmaceutical cleanroom standard), and ISO 14644-2:2015 (monitoring and testing methods). For regulated industries, it supports 21 CFR Part 11-compliant audit trails, role-based access control, and electronic signature workflows when paired with Kanomax’s validated PC software suite. Full documentation packages—including factory calibration certificates traceable to NMIJ (Japan) and uncertainty budgets—are supplied with each unit.

Software & Data Management

Data acquisition, analysis, and reporting are managed through Kanomax’s proprietary Cleanroom Manager Pro software (Windows-based, validated for GxP environments). The software enables automated mapping of sampling locations using customizable floor plans, batch-level statistical summaries (mean, SD, UCL), and automatic generation of ISO 14644-1 classification reports compliant with Annex A and B. All raw data files (.kpc format) are digitally signed and encrypted during transfer; metadata—including operator ID, instrument serial number, calibration status, and environmental sensor inputs—is embedded and immutable. Audit logs record every data modification event with timestamp, user context, and reason code. Export options include CSV, PDF, and XML formats compatible with LIMS integration. Firmware updates and configuration templates can be deployed remotely via Ethernet or locally via USB.

Applications

The 3910 serves as a primary verification tool across regulated and precision manufacturing sectors. In pharmaceutical facilities, it performs routine monitoring of Grade A laminar airflow hoods, isolators, and filling lines—supporting Annex 1 (2022) requirements for real-time particle surveillance during aseptic processing. Semiconductor fabs deploy the instrument for periodic qualification of photolithography cleanrooms (Class 1–10), while medical device manufacturers use it to validate packaging clean zones per ISO 13485. Additional applications include HEPA filter leak testing (via upstream challenge and downstream scanning), HVAC commissioning, aerospace clean assembly verification, and university cleanroom certification. Its modular sensor interface allows concurrent measurement of temperature, relative humidity, differential pressure, and air velocity—providing contextual environmental data essential for root-cause analysis of excursions.

FAQ

Does the Kanomax 3910 comply with ISO 14644-1:2015 and EU GMP Annex 1 (2022)?

Yes—the instrument’s counting performance, sampling protocol logic, and reporting structure fully align with both standards. Classification algorithms implement the required 95% UCL calculation and spatial sampling rules.
Can the 3910 be used for compressed air monitoring?

Yes, when equipped with a pressure-regulated inlet module and appropriate desiccant/diffuser accessories to prevent condensation and particle agglomeration.
Is the internal data storage sufficient for long-term monitoring programs?

The 10,000-sample capacity supports ~3 months of typical shift-based monitoring; however, scheduled USB export or Ethernet-based cloud synchronization is recommended for archival integrity.
What calibration documentation is provided?

Each unit ships with an NMIJ-traceable calibration certificate covering flow rate, size calibration, counting efficiency, and background noise—valid for 12 months under normal operating conditions.
How is 21 CFR Part 11 compliance implemented?

Through Cleanroom Manager Pro software: electronic signatures require dual authentication, all data modifications generate immutable audit trails, and system access is governed by configurable user roles with password policies and session timeouts.