Kanomax 3910 High-Flow Laser Particle Counter for Cleanroom Classification

Overview

The Kanomax 3910 is a high-precision, portable laser particle counter engineered for definitive cleanroom classification and environmental monitoring in regulated manufacturing and research environments. It operates on the principle of single-particle light scattering (SPLS) using a stable 650 nm laser diode source, enabling real-time detection and sizing of airborne particulates across six user-defined channels within the 0.3–10.0 µm range. With a calibrated volumetric flow rate of 50 L/min, the instrument meets ISO 21501-4 requirements for counting efficiency, resolution, and coincidence loss—ensuring metrological traceability to national standards. Its architecture supports both static point sampling and dynamic scanning protocols, making it suitable for ISO 14644-1:2015 Class 1–9 cleanroom certification, HEPA filter leak testing per ISO 14644-3, and continuous environmental monitoring in Grade A/B/C/D zones under EU GMP Annex 1 and USP . The device delivers quantitative aerosol data with documented uncertainty, forming an auditable foundation for quality risk management (QRM) and process validation.

Key Features

• High-flow sampling at 50 L/min—reduces statistical uncertainty and accelerates compliance verification per ISO 14644-1 sampling plan requirements
• Six simultaneous particle size channels (standard: 0.3, 0.5, 1.0, 3.0, 5.0, 10.0 µm); customizable binning within 0.3–10.0 µm range
• Integrated 6.4-inch capacitive touchscreen interface with intuitive icon-driven navigation and multilingual (English/Chinese) UI
• Built-in thermal printer for immediate generation of compliant test reports—including ISO 14644-1 classification statements, raw count tables, and pass/fail determinations
• Onboard storage for up to 10,000 measurement records; expandable via USB 2.0 port for mass data export or firmware updates
• Dual hot-swappable Li-ion battery modules supporting >4 hours of continuous operation (typical)
• Real-time alarm system with dual-tone audio feedback for concentration exceedance, flow deviation (>±5%), laser output anomaly, or sensor fault
• Full compliance with ISO 21501-4 for counting efficiency, resolution, and false count rate (<0.2 particles/ft³), including zero-count verification per JIS B 9921

Sample Compatibility & Compliance

The Kanomax 3910 is validated for use with standard isokinetic sampling probes and optional accessories including differential pressure transducers, NIST-traceable temperature/humidity sensors, and velocity probes—enabling concurrent measurement of ISO 14644-2 environmental parameters. All particle count data adhere to ISO 14644-1:2015 statistical sampling rules and reporting conventions. Instrument calibration is performed against NIST-traceable PSL standards; certificate of calibration includes uncertainty budget per ISO/IEC 17025. Software-generated reports satisfy 21 CFR Part 11 requirements through role-based access control, electronic signatures, and immutable audit trails. Regulatory alignment extends to EU GMP Annex 1 (2022), Chinese GMP 2010, GB 50333–2013 (Hospital Clean Operating Rooms), and British Standard BS EN ISO 14644 series.

Software & Data Management

The included Kanomax Data Manager software (Windows-compatible) provides secure import, visualization, and report generation from internal memory or USB media. Raw datasets include timestamp, location ID, operator ID, sampling duration, flow verification status, and ambient condition metadata. Export formats include CSV, PDF (with embedded digital signature), and XML for LIMS integration. Audit trail functionality logs all user actions—including report edits, parameter changes, and calibration events—with time-stamped, non-erasable entries. Data encryption (AES-256) and password-protected user profiles ensure integrity during transfer and archival. Optional cloud synchronization enables centralized fleet monitoring for multi-site pharmaceutical facilities.

Applications

• Final classification and periodic requalification of cleanrooms and isolators per ISO 14644-1 and EU GMP Annex 1
• HEPA/ULPA filter integrity testing using upstream challenge and downstream scanning protocols
• In-process environmental monitoring (EPM) during aseptic processing, lyophilization, and filling operations
• Validation of laminar airflow workstations, biosafety cabinets, and gloveboxes
• Contamination investigation and root cause analysis in semiconductor fabrication and medical device manufacturing
• Supporting ISO 14644-2 surveillance testing for occupancy state transitions (as-built, at-rest, operational)
• Research-grade aerosol characterization in nanotechnology labs and cleanroom HVAC commissioning

FAQ

Does the Kanomax 3910 meet FDA 21 CFR Part 11 requirements for electronic records?

Yes—the device supports electronic signatures, audit trail logging, and role-based access control when used with validated Kanomax Data Manager software.
Can the 3910 be used for ISO 14644-3 filter leak testing?

Yes—its high flow rate, low false count rate, and real-time alarm enable rapid scanning of filter edges and seals per ISO 14644-3 Annex B.
What is the maximum allowable particle concentration before coincidence error exceeds specification?

Per ISO 21501-4, the upper limit is 500,000 particles/ft³ at 50 L/min flow; automatic coincidence correction is applied above 150,000 particles/ft³.
Is external sensor data (e.g., temperature, humidity) embedded in exported reports?

Yes—when connected to optional Kanomax environmental sensors, all synchronized measurements are time-stamped and included in PDF and CSV exports.
How is calibration traceability maintained?

Each unit ships with a factory calibration certificate referencing NIST-traceable PSL standards; annual recalibration is recommended per ISO/IEC 17025 guidelines.