Kanomax 3905 High-Flow Airborne Particle Counter

Overview

The Kanomax 3905 High-Flow Airborne Particle Counter is an ISO 21501-4 compliant optical particle counter engineered for rapid, quantitative assessment of airborne particulate contamination in controlled environments. Utilizing a high-stability laser diode light source and optimized Mie scattering detection geometry, the instrument measures particle concentrations across six user-selectable size channels simultaneously—standard configuration includes 0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm—within a nominal volumetric flow rate of 28.3 L/min (1 ft³/min). This flow rate enables statistically robust sampling in accordance with ISO 14644-1:2015 minimum sampling volume requirements for Class 5 (ISO 5) and higher cleanroom classifications. The device operates on the principle of single-particle light scattering, where each particle traversing the focused laser beam generates a pulse proportional to its projected area; signal amplitude is classified into discrete size bins using calibrated photodetector thresholds. Its architecture integrates real-time flow monitoring, temperature-compensated timing circuits, and dual-redundant battery slots to ensure uninterrupted operation during extended qualification protocols.

Key Features

• Simultaneous six-channel particle counting at 28.3 L/min with traceable calibration per ISO 21501-4
• 6.4-inch full-color resistive touchscreen interface supporting bilingual (English/Chinese) operation and intuitive workflow navigation
• Onboard thermal printer enabling immediate generation of ISO-compliant test reports with embedded timestamp, location ID, and operator credentials
• Internal non-volatile memory stores up to 10,000 complete sampling records—including raw channel counts, environmental metadata, and pass/fail status against ISO 14644-1 limits
• USB host port for external flash drive data export and firmware updates; Ethernet interface supports remote monitoring and integration into centralized facility management systems
• Dual hot-swappable Li-ion battery modules provide >4 hours continuous operation; AC adapter (100–240 V, 50–60 Hz) included for benchtop or fixed-location use
• Integrated audit trail functionality compliant with FDA 21 CFR Part 11, including electronic signatures, user access control, and immutable event logging

Sample Compatibility & Compliance

The Kanomax 3905 is validated for use in ISO Class 3–8 (ISO 14644-1:2015) and EU GMP Grade A–D environments. It meets the performance criteria defined in ISO 21501-4 for optical particle counters, including sizing resolution (<15% at 0.3 µm), counting efficiency (50±20% at 0.3 µm), and false count rate (<0.2 particles/ft³). All measurements are traceable to NIST-traceable reference aerosols. The instrument satisfies national and international regulatory frameworks: GB/T 16292–2010 (China), JJF 1190–2008 (Chinese metrological verification regulation), BS 5295 (UK), and EC GMP Annex 1 requirements for cleanroom certification and HEPA filter leak testing. Optional environmental sensors (temperature, RH, differential pressure, air velocity) extend compliance to ISO 14644-2:2015 monitoring protocols requiring concurrent environmental parameter recording.

Software & Data Management

Data acquisition, analysis, and reporting are managed through Kanomax’s proprietary PC-based software suite, compatible with Windows 10/11 and supporting CSV, PDF, and XML export formats. The software enforces structured data entry—including sampling point ID, ISO classification target, and operational notes—and auto-generates summary statistics (mean, standard deviation, 95% UCL) required for ISO 14644-1 compliance reporting. Audit trail logs record all user actions—including method changes, calibration events, and report generation—with timestamps, operator IDs, and IP addresses (when networked). Electronic signatures comply with 21 CFR Part 11 Subpart C requirements for closed systems, including role-based access levels, password complexity enforcement, and session timeout controls. Raw data files are cryptographically hashed to prevent tampering, and backups may be archived to network drives or cloud storage per organizational SOPs.

Applications

• Certification and routine monitoring of pharmaceutical cleanrooms (ISO 5–8), aseptic processing isolators, and RABS environments
• HEPA and ULPA filter integrity testing via upstream/downstream scanning per ISO 14644-3 and IEST-RP-CC034.2
• Validation of laminar airflow workstations, biosafety cabinets, and gloveboxes in biotech and academic laboratories
• Particle challenge studies during equipment qualification (IQ/OQ/PQ) and process simulation (media fills)
• Environmental monitoring in semiconductor fabrication facilities where sub-0.3 µm sensitivity is not required but high-volume throughput is critical
• Compliance audits under FDA, EMA, PMDA, and NMPA regulatory inspections requiring documented evidence of environmental control

FAQ

Does the Kanomax 3905 support remote data retrieval via Ethernet?
Yes—the device features a 10/100BASE-TX Ethernet port enabling TCP/IP communication for real-time data streaming, remote configuration, and centralized database synchronization using standard MODBUS TCP or Kanomax’s native protocol.
Is the internal printer capable of generating ISO 14644-1-compliant reports without PC software?
Yes—on-device report generation includes mandatory fields per ISO 14644-1 Annex D: sampling location, date/time, flow rate, particle counts per channel, calculated 95% UCL, and pass/fail determination against specified class limits.
Can the instrument be used for filter leak testing per ISO 14644-3?
Yes—when paired with the optional scanning probe and differential pressure sensor, the 3905 supports quantitative leak mapping of HEPA/ULPA filters at scan velocities up to 5 cm/s, with automatic dwell-time adjustment and integrated pass/fail threshold logic.
What is the calibration interval recommendation per ISO 21501-4?
Annual calibration is recommended; however, users must perform daily zero-count verification using the supplied HEPA-filtered air supply and weekly flow verification using a NIST-traceable flowmeter as part of their quality system.
Does the device meet FDA 21 CFR Part 11 requirements for electronic records?
Yes—the firmware implements full Part 11 controls: electronic signatures with biometric or multi-factor authentication options, audit trail with immutable timestamps, and secure user role management—all validated per IQ/OQ protocols available upon request.