Kanomax Remote Airborne Particle Counter Model 3720-06

Overview

The Kanomax Remote Airborne Particle Counter Model 3720-06 is a high-reliability, fixed-installation particle monitoring instrument engineered for continuous, unattended operation in critical cleanroom environments, pharmaceutical manufacturing suites, isolators, and controlled HVAC ducts. It employs light scattering photometry—where airborne particles pass through a focused laser beam and generate scattered light pulses proportional to their size—to quantify particulate concentration in real time. Each pulse is classified into user-selectable size bins (2–4 channels from 0.3 µm to 10.0 µm), enabling compliance-aligned monitoring per ISO 14644-1, EU GMP Annex 1, and USP . Designed for integration into facility-wide environmental monitoring systems (EMS), the 3720-06 delivers stable, traceable measurements with long-term calibration integrity—supported by its ISO 21501-4–certified optical system and NIST-traceable counting efficiency across all configured channels.

Key Features

• Robust 316 stainless steel housing with hermetic sealing—validated for repeated exposure to vaporized hydrogen peroxide (VHP) and 70% isopropyl alcohol (IPA) sterilization cycles without performance degradation.
• Integrated vacuum sampling pump rated for >20,000 hours of continuous operation; field-replaceable without tools or system shutdown.
• Power flexibility: supports Power over Ethernet (PoE, IEEE 802.3af), wide-range DC input (15–28 V), or universal AC (100–240 V)—enabling deployment in both new-build infrastructure and legacy utility corridors.
• Dual-layer data resilience: non-volatile storage for 5,000 timestamped records + 2,000-entry circular buffer with automatic redundancy backup to prevent loss during network interruption or power fluctuation.
• Industrial-grade I/O: native Modbus TCP/IP and Modbus RTU protocols over Ethernet and RS-485, plus isolated 4–20 mA analog outputs per channel—each independently configurable for particle count or concentration units.
• Laser diode with >10-year MTBF ensures minimal drift and reduced recalibration frequency—critical for audit readiness under FDA 21 CFR Part 11 and EU Annex 11 requirements.

Sample Compatibility & Compliance

The 3720-06 is validated for use with ambient air, compressed gases (including nitrogen and medical air), and HEPA-filtered supply streams. Its isokinetic sampling inlet minimizes bias in duct-mounted applications. All optical and electronic components meet IEC 61000-4 immunity standards for electromagnetic compatibility in industrial settings. The device conforms to ISO 21501-4:2018 (calibration and counting efficiency), JIS B 9921:2019 (performance criteria), and supports IQ/OQ documentation packages aligned with GAMP 5. It is compatible with validated EMS platforms that require ALCOA+ data integrity principles—including audit trails, electronic signatures, and change control logs.

Software & Data Management

While the 3720-06 operates autonomously as a sensor node, it interfaces seamlessly with third-party SCADA, MES, and EMS software via standard Modbus registers. Each channel’s alarm thresholds (0–100% of set limit), output scaling (e.g., 0–10,000 counts/ft³ → 4–20 mA), and logging intervals are programmable remotely—eliminating manual onsite configuration. Data export supports CSV and XML formats for trend analysis in tools such as Tableau or Spotfire. For regulated environments, the unit supports time-synchronized logging with NTP-enabled controllers, ensuring temporal consistency across multi-sensor networks required for ISO 14644-2 classification reports.

Applications

• Continuous monitoring of Grade A/B cleanrooms in aseptic processing facilities (per EU GMP Annex 1, 2022 revision).
• In-duct particle surveillance upstream/downstream of ULPA filters in semiconductor fab HVAC systems.
• Real-time release testing support for sterile product filling lines using statistical process control (SPC) dashboards.
• Environmental qualification of isolators and RABS during commissioning and periodic requalification.
• Validation of VHP decontamination cycles—leveraging its resistance to aggressive biocidal vapors and stable baseline recovery post-cycle.

FAQ

Does the 3720-06 support FDA 21 CFR Part 11-compliant data handling?
No—the instrument itself does not include built-in electronic signature or audit trail functionality. However, it provides raw, timestamped, and unalterable measurement data via Modbus registers and analog outputs, enabling full Part 11 compliance when integrated with validated EMS platforms that implement required controls.
Can particle size channels be reconfigured in the field?
No—channel selection (2–4 sizes from the 0.3–10.0 µm range) is fixed at factory configuration and cannot be modified post-delivery due to optical alignment and firmware calibration dependencies.
Is external calibration required annually?
Per ISO 21501-4, annual verification against NIST-traceable reference aerosols is recommended. Kanomax provides certified calibration services and on-site verification kits for in-house interval checks.
What is the maximum cable length for RS-485 communication?
Up to 1,200 meters at 9.6 kbps, provided twisted-pair shielded cable (AWG 24) and proper termination resistors are used per EIA/TIA-485 standards.
Does the unit comply with explosion-proof or hazardous area classifications?
No—it is rated for general-purpose indoor use only (IP54 enclosure rating) and is not certified for Class I Div 1 or ATEX Zone 0/1 environments.