Kanomax 3720-06 Remote Airborne Particle Counter

Overview

The Kanomax 3720-06 is a high-reliability remote airborne particle counter engineered for continuous, unattended monitoring in critical cleanroom environments, pharmaceutical manufacturing suites, isolators, and aseptic processing areas. It operates on the principle of light scattering—where particles drawn through a precisely controlled laminar airflow intersect with a stable, long-life laser diode beam, generating scattered photons proportional to particle size and refractive index. Signal processing algorithms convert pulse height and frequency into discrete particle counts per standardized size bin, traceable to ISO 21501-4 and JIS B 9921 calibration requirements. With a nominal flow rate of 28.3 L/min (1.0 CFM), the instrument delivers statistically robust sampling for ISO Class 5–8 cleanrooms and supports compliance-driven validation protocols under EU GMP Annex 1, FDA Guidance for Aseptic Processing, and ICH Q9 risk-based monitoring frameworks.

Key Features

• Modular vacuum sampling pump—field-replaceable without tools, enabling rapid maintenance and minimizing system downtime during qualification or routine service.
• PoE (IEEE 802.3af) support with hot-swap capability—eliminates need for local power infrastructure and simplifies deployment across distributed cleanroom zones.
• 316 stainless steel housing with hermetic sealing—certified resistance to vaporized hydrogen peroxide (VHP) and 70% ethanol sterilization cycles, ensuring integrity during decontamination phases.
• Dual communication architecture—simultaneous Modbus TCP/IP over Ethernet and Modbus RTU over RS-485, plus configurable 4–20 mA analog outputs per selected channel for integration with DCS, SCADA, or BMS platforms.
• Onboard data resilience—5,000 full-test records stored internally with cyclic buffering of 2,000 real-time samples; automatic redundancy backup prevents data loss during network interruption or power fluctuation.
• Laser diode with ≥100,000-hour MTBF—engineered for continuous operation (>20,000 hours at rated vacuum duty cycle), reducing recalibration frequency and supporting long-term trend analysis.

Sample Compatibility & Compliance

The 3720-06 is validated for use with ambient air, compressed gases (N₂, CO₂, medical air), and HEPA-filtered process streams. Its isokinetic sampling inlet ensures representative particle capture across varying duct velocities. The device meets ISO 21501-4:2018 for optical particle counter performance verification—including sizing accuracy (±10% tolerance for 0.5 µm PSL), counting efficiency (≥50% at 0.3 µm, ≥100% at ≥0.5 µm), and false count rate (<1 count/5 min). All firmware and configuration logs support audit trails compatible with 21 CFR Part 11 requirements when integrated with compliant data management systems. Calibration certificates are issued per ISO/IEC 17025-accredited laboratories and include uncertainty budgets traceable to NIST standards.

Software & Data Management

While the 3720-06 operates autonomously as a sensor node, it interfaces seamlessly with Kanomax’s KAN-View™ central monitoring software (sold separately) for multi-device fleet management, alarm correlation, and electronic batch record generation. Raw data exports in CSV format include timestamp, channel-specific counts, environmental metadata (temperature/humidity if externally fed), and status flags (e.g., flow error, saturation warning). All configuration changes—channel selection, alarm thresholds, output scaling—are logged with user ID and UTC timestamp. Optional OPC UA gateway modules enable direct integration into MES and LIMS platforms adhering to ISA-95 and ASTM E2500-15 lifecycle documentation standards.

Applications

• Real-time ISO classification verification during cleanroom commissioning and periodic requalification.
• Continuous monitoring of Grade A/B zones in sterile drug manufacturing per EU GMP Annex 1 (2022 revision).
• Trend analysis of particle excursions linked to HVAC filter degradation, personnel activity, or equipment maintenance events.
• Environmental monitoring (EM) program execution in biologics and cell/gene therapy facilities where rapid detection of sub-micron contamination is critical.
• Integration into automated environmental control systems for dynamic alarm escalation (e.g., triggering interlocks upon sustained exceedance of action levels).

FAQ

What particle size channels are factory-configurable?
The 3720-06 supports any combination of 2–4 size bins from the standard set: 0.3, 0.5, 0.7, 1.0, 3.0, 5.0, and 10.0 µm. Default shipment configuration is 0.5 µm and 5.0 µm.
Is the device suitable for VHP-decontaminated isolators?
Yes—the 316 stainless steel enclosure and fluorosilicone gasketing are validated for repeated exposure to 30–50% VHP concentration at 60–75°C, with no measurable impact on optical alignment or seal integrity.
Does it support 21 CFR Part 11-compliant data handling?
The hardware provides tamper-evident logging and time-stamped configuration history; full Part 11 compliance requires implementation of a validated software layer (e.g., KAN-View™ with electronic signatures and audit trail review functions).
Can the vacuum pump be serviced without removing the unit from the duct?
Yes—the pump module is accessible via a front-panel quick-release latch and can be exchanged in under 90 seconds without interrupting airflow path integrity or requiring recalibration.
What is the maximum allowable particulate concentration before coincidence error becomes significant?
At 28.3 L/min flow, the upper limit for <5% coincidence error is 1,000,000 counts/ft³ (35,300,000 counts/m³) per ISO 21501-4 Annex C guidance—well above typical cleanroom operational limits.