KANOMAX 3715-06D Remote Airborne Particle Counter for Pharmaceutical Cleanroom Classification

Overview

The KANOMAX 3715-06D is a high-reliability, remotely operable airborne particle counter engineered specifically for continuous environmental monitoring in regulated pharmaceutical manufacturing environments. It employs laser diode-based light scattering detection to quantify particulate contamination across six standardized size channels—0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm—in real time at a calibrated volumetric flow rate of 2.83 L/min (0.1 CFM). Designed in strict accordance with ISO 21501-4 and JIS B 9921 for optical particle counter performance validation, the instrument delivers traceable, repeatable measurements essential for ISO 14644-1 cleanroom classification, EU GMP Annex 1 compliance, and FDA 21 CFR Part 11-aligned data integrity workflows. Its modular architecture supports both fixed installation and mobile verification applications, making it suitable for Grade A through D cleanroom zones, isolators, RABS, and HVAC duct monitoring points.

Key Features

• Laser diode light source with ≥10-year mean time between failures (MTBF), eliminating frequent lamp replacement and ensuring long-term measurement stability.
• Integrated vacuum pump with 8,000-hour service life and real-time pump status monitoring via front-panel indicators.
• Multi-mode power flexibility: supports Power over Ethernet (PoE), universal AC input (100–240 VAC), wide-range DC input (12–24 VDC), and optional external battery packs for temporary deployment.
• 4.3-inch capacitive touchscreen interface with intuitive navigation, on-device alarm configuration, and local data review without external software.
• Comprehensive communication suite: dual-mode Modbus support (RTU over RS-485 and TCP/IP over Ethernet/Wi-Fi), enabling seamless integration into SCADA, MES, and centralized environmental monitoring systems (EMS).
• Corrosion- and steam-resistant enclosure rated for repeated exposure to VHP (vaporized hydrogen peroxide) decontamination cycles—critical for aseptic processing areas.
• Onboard data logging capacity of 4,320 sample records with timestamp, channel-specific counts, flow rate, temperature, and relative humidity (when equipped with optional sensor).

Sample Compatibility & Compliance

The 3715-06D is validated for use in non-viable airborne particle monitoring per ISO 14644-1:2015, ISO 14644-2:2015, and EU GMP Annex 1 (2022). Its counting efficiency meets the rigorous tolerances defined in ISO 21501-4 for instruments used in regulatory-grade environments. The device supports audit-ready operation under GLP and GMP frameworks, with configurable alarm thresholds (0–100% setpoints), user-accessible calibration logs, and full traceability of all stored events—including sampling start/stop times, operator ID (via EMS integration), and system error flags. Optional temperature and humidity sensing enables simultaneous environmental parameter correlation—supporting holistic risk assessment per ICH Q5C and ISPE Baseline Guide Vol. 1.

Software & Data Management

Data export is supported via USB mass storage or network transfer (FTP/SFTP), generating CSV-formatted reports compatible with LIMS, ELN, and statistical process control platforms. When deployed with KANOMAX’s optional Wi-Fi base station, the unit enables secure over-the-air firmware updates and remote diagnostics. All logged entries include ISO-compliant metadata: date/time stamp (with NTP synchronization support), instrument serial number, sampling location ID, operator identifier (if EMS-linked), and environmental context. The embedded data buffer ensures no loss during transient network outages, with automatic resumption of transmission upon reconnection. Audit trail functionality satisfies FDA 21 CFR Part 11 requirements when integrated with compliant EMS platforms offering electronic signatures and role-based access control.

Applications

• Continuous monitoring of Grade A laminar airflow workstations and isolator interiors during aseptic filling operations.
• Periodic certification and requalification of cleanrooms per ISO 14644-1 classification protocols.
• Filter integrity verification and HVAC system performance trending in Grade B/C background areas.
• Environmental baseline studies during facility commissioning and qualification (IQ/OQ/PQ).
• Real-time deviation detection and root cause analysis during media fill simulations or process validation runs.
• Mobile particle mapping across production suites using battery-powered operation and Bluetooth-enabled tablet interfaces.

FAQ

Is the 3715-06D compliant with ISO 21501-4 for calibration traceability?
Yes—the instrument undergoes factory calibration against NIST-traceable reference aerosols and includes a certificate of conformance with documented uncertainty values per ISO 21501-4 Annex B.
Can the unit operate unattended for extended periods in a Grade A hood?
Yes—its steam-resistant housing, low-power consumption (<8 W), and internal vacuum pump enable continuous operation for up to 8,000 hours without maintenance, provided ambient conditions remain within 10–30 °C and ≤85 %RH.
Does the device support electronic signatures and audit trails for 21 CFR Part 11 compliance?
The 3715-06D itself does not generate electronic signatures; however, its Modbus TCP/IP output and structured CSV logging are fully compatible with validated EMS platforms that implement Part 11 controls including user authentication, change history, and immutable record retention.
What is the recommended recalibration interval?
KANOMAX recommends annual recalibration against certified reference standards, aligned with ISO/IEC 17025-accredited laboratories and documented in accordance with internal SOPs for metrological traceability.
Can temperature and humidity data be synchronized with particle counts in a single timestamped record?
Yes—when the optional integrated T/RH sensor is installed, all six particle channels, temperature, and relative humidity are captured simultaneously and stored as a unified data point with microsecond-level timestamp alignment.