Kanomax Model 3715-06D Remote Airborne Particle Counter

Overview

The Kanomax Model 3715-06D is a high-reliability, remotely operable airborne particle counter engineered for continuous environmental monitoring in cleanrooms, pharmaceutical manufacturing suites, semiconductor fabrication facilities, and controlled laboratory environments. It employs light scattering detection via a stable, long-life laser diode to quantify particulate contamination across six calibrated size channels—0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm—enabling real-time compliance assessment against ISO 14644-1, EU GMP Annex 1, and USP / standards. With a nominal sampling flow rate of 2.83 L/min (0.1 CFM), the instrument meets the metrological requirements for Class 5–8 cleanroom classification and routine process validation. Its integrated vacuum pump eliminates dependency on external air handling systems, while its modular architecture supports flexible deployment—whether wall-mounted, duct-integrated, or rack-mounted in centralized monitoring networks.

Key Features

• Compliance-certified optical design: Fully aligned with ISO 21501-4 and JIS B 9921 for counting efficiency, size resolution, and false count suppression.
• Multi-mode power architecture: Supports PoE (IEEE 802.3af), wide-range DC (12–24 V), universal AC (100–240 V), and optional battery-backed operation for mission-critical continuity.
• Embedded intelligence: 4.3-inch capacitive touchscreen interface with intuitive navigation, real-time concentration graphs, and configurable alarm thresholds (0–100% setpoint, ON/OFF or latching).
• Robust internal vacuum system: High-efficiency diaphragm pump rated for 8,000 hours of continuous operation; maintains stable flow across variable backpressure conditions.
• Dual communication stack: Simultaneous RS-485 and Ethernet interfaces enable seamless integration into SCADA, BMS, or MES platforms using standard Modbus RTU or TCP/IP protocols.
• Traceable data integrity: Onboard non-volatile memory stores up to 4,320 timestamped records—including particle counts per channel, flow status, laser health, and environmental sensor readings—with automatic rollover and UTC-synchronized logging.

Sample Compatibility & Compliance

The 3715-06D is validated for use with ambient indoor air, HEPA-filtered supply air, and recirculated process air streams. Its inlet geometry and isokinetic sampling nozzle minimize aspiration bias across laminar and turbulent flow regimes. The instrument’s counting performance is traceable to NIST-calibrated reference aerosols and undergoes factory verification per ISO 21501-4 Annex C. It supports audit-ready operation under FDA 21 CFR Part 11 when deployed with compliant software platforms—featuring electronic signatures, user access control, and immutable audit trails for all configuration changes and alarm events. Optional integrated temperature and humidity sensors meet ASTM E77 and ISO 17025 calibration traceability requirements when used with accredited third-party verification.

Software & Data Management

Kanomax provides the optional KANOMAX Monitor Suite—a Windows-based configuration and visualization application that enables remote device setup, historical trend analysis, automated report generation (PDF/CSV), and alarm notification via email or SNMP trap. All data exports include embedded metadata: instrument ID, firmware version, calibration date, operator ID, and environmental context. When connected to enterprise-grade infrastructure, the 3715-06D supports TLS-encrypted data transmission and integrates natively with LabVantage, TrackWise, and Siemens Desigo CC platforms. Data retention policies, user role hierarchies, and electronic signature workflows align with GLP and GMP Annex 11 expectations for computerized system validation (CSV).

Applications

• Continuous monitoring of ISO Class 5–8 cleanrooms during aseptic processing and sterile fill-finish operations.
• In-line verification of HEPA/ULPA filter integrity and airflow uniformity in critical zones (e.g., ISO 5 laminar flow hoods).
• Environmental qualification of isolators, RABS, and containment systems per PDA TR27 and ISO 14644-3.
• Real-time trending of particle excursions during equipment qualification (IQ/OQ/PQ) and change control assessments.
• Supporting risk-based monitoring strategies in API synthesis and biologics manufacturing environments.
• Integration into HVAC commissioning protocols to validate air change rates and pressure differentials.

FAQ

Does the 3715-06D require annual recalibration?
Yes—per ISO 21501-4 Clause 7.3, optical alignment and counting efficiency verification must be performed at least annually by an ISO/IEC 17025-accredited laboratory. Kanomax recommends quarterly functional checks using NIST-traceable polystyrene latex (PSL) spheres.

Can the instrument operate unattended for extended periods?
Yes—its MTBF exceeds 10 years, and onboard data logging ensures uninterrupted recordkeeping for up to 30 days at 1-minute sampling intervals without external storage.

Is the built-in vacuum pump serviceable in the field?
No—the pump is sealed and non-user-serviceable; replacement requires return-to-factory service under warranty or extended maintenance agreement.

What are the minimum system requirements for KANOMAX Monitor Suite?
Windows 10/11 (64-bit), 4 GB RAM, 500 MB free disk space, .NET Framework 4.8, and administrator privileges for driver installation.

Does the device support time-synchronized multi-unit networks?
Yes—via NTP-enabled Ethernet connection or optional GPS-sync module, enabling sub-second temporal alignment across distributed sensor arrays for spatial contamination mapping.