KANOMAX 3720-06 Remote Airborne Particle Counter for ISO Classified Operating Rooms

Overview

The KANOMAX 3720-06 is a fixed-mount, remote airborne particle counter engineered for continuous, unattended monitoring of cleanroom environments in healthcare critical zones—particularly ISO 5–ISO 8 classified operating rooms, sterile preparation areas, and laminar flow hoods. It operates on the principle of light scattering photometry: aerosolized particles drawn through a precisely controlled laminar airflow intersect a collimated Class II laser beam; scattered photons are detected by a high-sensitivity photodiode array and converted into digital pulse signals proportional to particle size and count. Calibration traceability adheres to 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 consistency across global pharmaceutical and surgical facility validation protocols.

Key Features

• Modular multi-channel detection: Configurable for simultaneous real-time counting of 2–4 user-selected particle size thresholds from the standard set (0.3, 0.5, 0.7, 1.0, 3.0, 5.0, 10.0 µm); factory-default setting is 0.5 µm and 5.0 µm—aligned with ISO 14644-1 classification requirements for surgical suites.
• Robust industrial enclosure: 316 stainless steel housing with hermetic gasket sealing, validated for repeated exposure to vaporized hydrogen peroxide (VHP) decontamination cycles and 70–90% ethanol vapor—critical for integration into terminal sterilization workflows without sensor degradation.
• High-reliability sampling architecture: Integrated vacuum pump with >20,000 hours of continuous operational life; field-replaceable without tools or system shutdown, minimizing downtime during scheduled maintenance or emergency recalibration.
• Flexible power and communication: Supports Power over Ethernet (PoE, IEEE 802.3af), DC 15–28 V, or universal AC 100–240 V input; enables deployment in electrically constrained or retrofit infrastructure without dedicated cabling.
• Dual-layer data integrity: Internal non-volatile memory stores up to 5,000 timestamped measurement records; additionally buffers the latest 2,000 entries in volatile RAM with automatic write-back and checksum-verified redundancy to prevent loss during transient power events.

Sample Compatibility & Compliance

The 3720-06 is designed exclusively for ambient air and compressed gas streams compliant with ISO 8573-1 Class 1–3 purity specifications. Its isokinetic sampling inlet ensures representative particle capture across variable duct velocities (0.1–1.0 m/s). The instrument meets electromagnetic compatibility (EMC) requirements per IEC 61326-1 (industrial environment) and safety standards per IEC 61010-1. For regulated healthcare facilities, its Modbus TCP/IP interface supports integration into SCADA and MES platforms compliant with FDA 21 CFR Part 11 (electronic records/signatures) when deployed with audit-trail-enabled host software. It is routinely specified in EU GMP Annex 1 (2022) and ISO 14644-2 surveillance programs for Grade A/B environments.

Software & Data Management

Raw count and concentration data (in units of counts/ft³, counts/m³, or counts/cubic foot) are transmitted via configurable Modbus registers or mapped to discrete 4–20 mA analog outputs—each independently scalable per particle channel (e.g., 0–10,000 counts/ft³ → 4–20 mA). Host systems may trigger alarms via digital I/O or Modbus coil writes. KANOMAX provides optional PC-based configuration utility (Windows) supporting firmware updates, calibration offset adjustment, and export to CSV/Excel. When integrated with validated environmental monitoring systems (EMS), the 3720-06 satisfies ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) under GxP-regulated operations.

Applications

• Continuous ISO classification verification in surgical operating rooms (ORs), cardiac catheterization labs, and transplant suites.
• Monitoring of HVAC supply air ducts upstream of HEPA/ULPA filters in hospital central plants.
• Validation support for aseptic processing isolators and restricted access barrier systems (RABS).
• Post-VHP decontamination cycle verification in biocontainment ORs and clean utility corridors.
• Real-time trending of particulate excursions during medical device assembly or sterile packaging line qualification.

FAQ

What particle size channels are pre-configured in the 3720-06 model shipped for operating room use?
The standard configuration includes 0.5 µm and 5.0 µm detection channels—selected to satisfy ISO 14644-1 minimum requirements for ISO Class 5 (≤3,520 particles/m³ ≥0.5 µm) and ISO Class 7 (≤352,000 particles/m³ ≥0.5 µm), while enabling coarse particle detection relevant to surgical draping integrity and gown shedding.
Can the 3720-06 be integrated into an existing BMS using BACnet or Profibus?
No—the device natively supports only Modbus RTU (RS-485), Modbus TCP/IP (Ethernet), and 4–20 mA analog output. BACnet or Profibus integration requires an external protocol gateway certified for cleanroom-grade electromagnetic immunity.
Is the laser source replaceable in the field, and what is its rated lifetime?
The Class II laser diode is not user-replaceable; it is sealed within the optical block and rated for ≥10 years MTBF under continuous operation at 25 °C ambient, consistent with ISO 21501-4 long-term stability criteria.
Does the unit comply with FDA requirements for electronic record retention in a hospital QA system?
Yes—when connected to a Part 11-compliant EMS platform that enforces audit trails, electronic signatures, and secure data archiving, the 3720-06 serves as a compliant data acquisition node. Its internal memory does not provide electronic signature capability but delivers raw, time-stamped, immutable records suitable for downstream validation.
What is the maximum allowable relative humidity for continuous operation?
The instrument operates continuously at 20–85% RH (non-condensing) at 10–30 °C. Condensation or dew point exposure will damage the optical chamber and void warranty; installation must avoid locations near steam sterilizers or humidified air ducts without desiccant pre-filtration.