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

Overview

The Kanomax 3910+ is a high-precision, 50 L/min airborne particle counter engineered for rigorous cleanroom validation, pharmaceutical facility monitoring, and ISO-classified environment qualification. It operates on the principle of single-particle light scattering (SPLS) using a stabilized 650 nm laser diode source, enabling real-time detection and classification of discrete particles across six user-selectable size channels—standardized at 0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm—with full compliance to ISO 21501-4 for counting efficiency, resolution, and false count performance. Its high-flow sampling architecture minimizes statistical uncertainty in low-concentration environments and significantly reduces required sampling time per location—critical for large-volume cleanrooms (e.g., ISO Class 5–8), isolators, and aseptic processing suites. The instrument’s optical design incorporates Mie scattering correction algorithms and calibrated flow control to ensure traceable, reproducible measurements aligned with international regulatory expectations.

Key Features

• 50 L/min volumetric flow rate with integrated mass flow sensor and active feedback control, maintaining < ±1 particle deviation over 5-minute intervals
• Six simultaneous particle size channels (0.3–10.0 µm), configurable per ISO 14644-1 or customer-defined thresholds
• 6.4-inch capacitive touchscreen interface with intuitive workflow navigation, multilingual UI (English/Chinese), and context-sensitive help
• Built-in thermal printer supporting on-the-spot generation of GMP-compliant test reports—including timestamp, location ID, operator name, and pass/fail status against ISO 14644-1 limits
• Dual rechargeable Li-ion battery slots enabling >4 hours continuous operation; AC adapter (100–240 V, 50–60 Hz) included
• USB 2.0 and Ethernet (10/100 Mbps) interfaces for secure data export, remote configuration, and integration into centralized environmental monitoring systems (EMS)
• Real-time alarm system with audible tones (distinctive error vs. limit-exceedance alerts) and on-screen diagnostics for flow anomaly, laser instability, zero-count failure, or concentration saturation

Sample Compatibility & Compliance

The 3910+ is validated for use in non-hazardous, ambient air sampling applications within controlled environments. It supports isokinetic sampling via optional dynamic probe kits and integrates seamlessly with external sensors for concurrent measurement of temperature (±0.5 °C), relative humidity (±3% RH), differential pressure (±1 Pa), and air velocity (±0.05 m/s). All firmware and calibration protocols adhere to ISO/IEC 17025 requirements for measurement traceability. Instrument validation documentation—including as-delivered calibration certificates (NIST-traceable reference aerosols), IQ/OQ templates, and risk-based PQ protocols—is provided. The device meets the technical and procedural requirements of ISO 14644-1:2015, ISO 14644-2:2015, EU GMP Annex 1 (2022), USP and , and China’s GB/T 16292–2010 and JJF 1190–2008 metrological verification standards. Electronic record integrity conforms to FDA 21 CFR Part 11 through embedded audit trail, role-based access control, and digital signature capability.

Software & Data Management

Kanomax K-Soft v4.2 (included) provides comprehensive post-processing, trend analysis, and report generation. Data files are stored in encrypted CSV and proprietary .kdf formats with embedded metadata (GPS coordinates optional via external module), operator ID, sampling duration, and environmental sensor logs. The software supports automated pass/fail evaluation per ISO 14644-1 sampling plan (e.g., ISO 14644-2 Annex D), UCL (Upper Confidence Limit) calculation per IEST-RP-CC006.3, and customizable dashboards for multi-site fleet management. Audit trail entries log all user actions—including parameter changes, data deletions, and report exports—with immutable timestamps and operator attribution. Exported datasets comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

Applications

• Cleanroom certification and routine monitoring in semiconductor fabrication, biopharmaceutical manufacturing, and medical device assembly
• Aseptic process simulation (media fill) environmental qualification per EU GMP Annex 1
• Filter integrity testing and HVAC system commissioning (e.g., HEPA/ULPA filter leak detection via upstream challenge)
• Pharmaceutical stability chambers and isolator glove port monitoring
• Research laboratories requiring high-statistical-confidence particle distribution profiling in laminar flow hoods and biosafety cabinets
• Third-party validation services supporting ISO 17025-accredited testing reports

FAQ

What calibration standards does the 3910+ follow?
It is factory-calibrated using NIST-traceable PSL (polystyrene latex) spheres and certified reference aerosols per ISO 21501-4. Annual recalibration is recommended and supported by Kanomax-certified service centers.
Can the 3910+ be used for ISO Class 3 (Class 1) environments?
Yes—its 0.3 µm sensitivity, low false count rate (<0.2 particles/ft³), and high flow rate enable statistically robust sampling in ultra-low concentration settings when deployed with appropriate sampling strategies and probe geometry.
Does the built-in printer support custom report templates?
Yes—K-Soft allows template customization including company logo, site-specific headers, regulatory references, and configurable pass/fail logic per ISO 14644-1 Annex B or client-defined specifications.
Is remote firmware update supported?
Firmware updates are performed via USB drive or Ethernet connection using signed update packages; no cloud dependency or internet exposure is required to maintain cybersecurity compliance.
How is data integrity ensured during power loss?
The device features non-volatile flash memory with automatic checkpointing—sample records in progress are preserved and resumed upon restart without data corruption or loss.