KANOMAX 3905 High-Flow Airborne Particle Counter

Overview

The KANOMAX 3905 is a high-flow airborne particle counter engineered for precision monitoring of particulate contamination in cleanroom environments, pharmaceutical manufacturing facilities, semiconductor fabrication suites, and controlled laboratory settings. Operating on the principle of light scattering photometry, the instrument draws ambient air at a calibrated volumetric flow rate of 28.3 L/min—equivalent to 1 cubic foot per minute (CFM)—enabling statistically robust sampling in accordance with ISO 14644-1 Annex B and EU GMP Annex 1 requirements. Its six-channel optical detection system simultaneously quantifies particles across six discrete size thresholds: 0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm. This multi-size capability supports comprehensive classification of cleanroom classes (ISO Class 3 to ISO Class 8), real-time trending of contamination events, and validation of HVAC filtration efficiency under dynamic operational conditions.

Key Features

• High-flow sampling at 28.3 L/min ensures rapid data acquisition with improved statistical confidence per unit time—critical for ISO-compliant cleanroom certification and routine surveillance.
• True-color 6.4-inch resistive touchscreen interface enables intuitive navigation, real-time histogram visualization, and on-device pass/fail evaluation against user-defined ISO or GMP cleanliness limits.
• Integrated thermal printer provides immediate hard-copy reporting compliant with GLP/GMP documentation standards—including timestamp, location ID, operator ID, and raw channel counts.
• Onboard memory stores up to 10,000 complete sampling records; USB port supports seamless export to external drives for long-term archival or audit-ready data transfer.
• Optional external sensor interface accommodates calibrated probes for environmental parameters: dry-bulb temperature (±0.5 °C), relative humidity (±3% RH), air velocity (±0.1 m/s), and differential pressure (±1 Pa)—all synchronized with particle count timestamps.
• Optical system features laser diode excitation and low-noise avalanche photodiode detection, optimized for high signal-to-noise ratio across the full 0.3–10.0 µm range without coincidence error correction artifacts.

Sample Compatibility & Compliance

The KANOMAX 3905 is designed for continuous or periodic sampling of non-corrosive, non-explosive indoor air in regulated environments. It is not intended for use in hazardous locations (ATEX/IECEx zones) or with aerosols containing volatile organic compounds (VOCs), oils, or condensable vapors that may contaminate the optical chamber. The instrument meets metrological traceability requirements outlined in JJF 1190–2008 (Chinese national calibration specification for airborne particle counters) and conforms to performance criteria defined in GB/T 16292–2010 (Chinese standard for cleanroom testing) and ISO 14644-1:2015 (Classification of air cleanliness by particle concentration). All firmware and measurement algorithms are validated per ISO/IEC 17025–compliant internal procedures, supporting audit readiness under FDA 21 CFR Part 11 when paired with appropriate electronic record controls.

Software & Data Management

Data output is structured in ASCII-delimited format (.csv), compatible with LIMS integration and statistical process control (SPC) platforms such as Minitab, JMP, or custom SQL-based dashboards. Each record includes absolute particle counts per channel, sampling duration, flow verification status, environmental sensor values (if active), and instrument serial number. Firmware supports configurable audit trails with operator login (PIN-based), session logging, and immutable event markers for calibration, maintenance, and configuration changes—fully aligned with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). No cloud connectivity is embedded; all data handling remains local unless exported manually via USB.

Applications

• Cleanroom qualification and routine monitoring per ISO 14644-2 and ISO 14644-3 protocols.
• Pharmaceutical aseptic processing environment verification (e.g., Grade A/B/C/D zones).
• Filter integrity testing and HEPA/ULPA filter leak detection using challenge aerosols.
• Microelectronics fab tool exhaust and recirculation duct monitoring.
• Medical device packaging cleanroom validation under ISO 13485 quality management systems.
• Environmental baseline studies for ISO 14644-6 contingency planning and risk assessment.

FAQ

What calibration standards does the KANOMAX 3905 support?
The instrument is factory-calibrated using NIST-traceable PSL (polystyrene latex) spheres and certified reference aerosols per ISO 21501-4. Field recalibration requires accredited service centers using ISO 17025-certified equipment.
Can the KANOMAX 3905 be used for outdoor ambient air monitoring?
No—it is designed exclusively for indoor, conditioned air environments. High humidity, particulate loading >1×10⁶ particles/m³, or sub-zero temperatures invalidate optical performance and violate operating specifications.
Is the built-in printer compliant with 21 CFR Part 11 for electronic signatures?
The printer generates audit-ready reports but does not provide electronic signature functionality. For Part 11 compliance, printed outputs must be accompanied by signed paper logs or integrated into a validated e-signature system outside the device.
Does the device support remote operation or network connectivity?
No Ethernet, Wi-Fi, or Bluetooth interfaces are included. Communication is limited to USB mass storage mode and RS-232 (optional accessory cable) for legacy SCADA integration.
How often does the flow sensor require verification?
Per ISO 14644-3, volumetric flow should be verified before each daily use or after transport; KANOMAX recommends quarterly verification using a primary-standard flow calibrator traceable to national metrology institutes.