KANOMAX Model 3720-06 Remote Airborne Particle Counter for Industrial Cleanroom Monitoring

Overview

The KANOMAX Model 3720-06 is a high-reliability remote airborne particle counter engineered for continuous, unattended monitoring of particulate contamination in critical controlled environments—including ISO Class 3–8 cleanrooms, pharmaceutical aseptic processing suites, semiconductor fabrication facilities, and hospital operating theatres. It operates on the principle of light scattering photometry: aerosolized particles drawn through a calibrated laminar flow path intersect a collimated laser beam; scattered light pulses are detected, classified by amplitude, and converted into real-time particle counts per unit volume. Its optical design and signal processing architecture comply strictly with ISO 21501-4 (Determination of particle size distribution—Single particle light interaction methods) and JIS B9921 (Cleanroom particle counters—Requirements and test methods), ensuring metrological traceability and inter-laboratory comparability.

Key Features

• Simultaneous multi-channel detection across 2–4 user-selectable particle size thresholds—from 0.3 µm to 10.0 µm—configured at factory to meet application-specific regulatory requirements (e.g., 0.5 µm and 5.0 µm for ISO 14644-1 classification of pharmaceutical Grade A/B zones).
• Robust 316 stainless steel enclosure with IP65-rated hermetic sealing, validated for repeated exposure to vaporized hydrogen peroxide (VHP) and 70% isopropyl alcohol (IPA) sterilization cycles without degradation of structural integrity or sensor performance.
• Dual-power architecture supporting Power over Ethernet (PoE, IEEE 802.3af), DC input (15–28 V), or universal AC (100–240 V), enabling flexible deployment in both new-build infrastructure and retrofitted cleanroom utility corridors.
• Integrated vacuum sampling pump with modular mechanical interface—designed for field replacement without recalibration—ensuring uninterrupted operation during scheduled maintenance or filter changeouts.
• Onboard data management system stores up to 5,000 timestamped measurement records (including date/time, channel counts, environmental status flags), with dual-layer buffering: 2,000 volatile cache entries plus non-volatile redundancy backup to prevent data loss during power interruption or network latency.

Sample Compatibility & Compliance

The 3720-06 is intended for monitoring ambient or process air in dry, non-corrosive gaseous environments. It is not suitable for oily mists, condensing vapors, or high-humidity saturated streams without upstream drying or dilution. Its calibration and counting efficiency are verified against NIST-traceable PSL (polystyrene latex) reference standards per ISO 21501-4 Annex B. The instrument supports audit-ready operation in regulated industries: Modbus TCP/IP and RS-485 interfaces facilitate integration into SCADA, MES, or DCS platforms compliant with FDA 21 CFR Part 11 (electronic records/signatures) when paired with validated software layers. Its firmware architecture includes immutable event logging and configurable alarm thresholds aligned with EU GMP Annex 1 (2022) and ISO 14644-2 surveillance protocols.

Software & Data Management

Data export is supported via Ethernet or serial interface using standard Modbus register mapping—enabling direct ingestion into third-party LIMS, PI System, or custom dashboards without proprietary drivers. The 4–20 mA analog output provides hardwired analog backup for legacy PLC-based alarm systems, with independent scaling per particle channel (e.g., 4–20 mA = 0–10,000 particles/m³ for 0.5 µm). Internal memory retains full-resolution time-series data with UTC timestamps, including pump status, flow verification flags, and temperature/humidity metadata where external sensors are connected. Firmware updates are performed via secure HTTP(S) or local USB—each release includes SHA-256 checksums and version-controlled changelogs traceable to internal QA documentation.

Applications

• Continuous ISO 14644-1 classification and monitoring of pharmaceutical isolators, filling lines, and Grade A laminar airflow hoods.
• Real-time trending of viable and non-viable particle excursions during VHP decontamination validation and recovery phases.
• Environmental qualification of medical device packaging cleanrooms (ISO 13485) and biotech cell therapy manufacturing suites.
• Baseline assessment and routine surveillance of HVAC filtration efficiency in hospital operating rooms and transplant units.
• Integration into facility-wide particle monitoring networks where centralized alarm correlation and root-cause analysis are required under cGMP or GLP frameworks.

FAQ

What particle size channels are pre-configured in the standard 3720-06 model?

The base configuration is set to 0.5 µm and 5.0 µm—aligned with ISO 14644-1 minimum requirements for Class 5 and above environments. Alternate combinations (e.g., 0.3/0.5/5.0/10.0 µm) are available upon order specification.
Is the instrument suitable for use in VHP-decontaminated isolators?

Yes—the 316 stainless steel housing and elastomer seals have undergone accelerated compatibility testing per ASTM E2500-13 against 1,000 ppm VHP at 60 °C for 20+ cycles with no measurable leakage or optical window haze.
Does the 3720-06 support 21 CFR Part 11 compliance?

The hardware itself provides the foundational controls (audit trail logging, electronic signature readiness, role-based access via external software); full Part 11 compliance requires implementation of a validated software layer managing user authentication, electronic signatures, and record retention per §11.10 and §11.30.
Can the sampling pump be replaced in the field without sending the unit for recalibration?

Yes—pump modules are mechanically and electrically isolated; replacement preserves factory-calibrated flow rate within ±2% tolerance per ISO 21501-4 section 6.3.2, eliminating need for re-certification.
What is the maximum allowable relative humidity for continuous operation?

Continuous operation is rated up to 85% RH at 30 °C, non-condensing. For extended exposure above 60% RH, installation with desiccant-dried purge air or co-location with dew point monitors is recommended to prevent internal condensation on optics.