KANOMAX 3718-A / 3719-A Remote Online Particle Counter for Pharmaceutical Cleanroom Classification

Overview

The KANOMAX 3718-A and 3719-A are certified online remote particle counters engineered for continuous, real-time airborne particulate monitoring in regulated pharmaceutical cleanrooms and isolators. Based on light scattering detection using a long-life laser diode source, these instruments comply with ISO 21501-4 for counting efficiency and size calibration accuracy, and meet the sampling and classification requirements of ISO 14644-1:2015 and JIS B 9921. Unlike portable or handheld counters, the 3718-A/3719-A series is designed for permanent installation in Grade A–D environments—supporting both unidirectional airflow (UDAF) and turbulent airflow (TAF) zones. Their external air supply architecture eliminates internal pump wear, ensuring stable 28.3 L/min (1 CFM) volumetric flow via integrated pressure feedback control. This flow stability is critical for statistical confidence in ISO 14644-1 classification reports and for meeting EU GMP Annex 1 (2022) requirements for continuous monitoring during aseptic processing.

Key Features

• Two dedicated models optimized for distinct regulatory use cases: 3718-A measures 0.3 µm and 0.5 µm particles—essential for Grade A/B classification per ISO 14644-1; 3719-A measures 0.5 µm and 5.0 µm particles—critical for detecting viable particle agglomerates and non-viable contamination in lower-grade support areas.
• 316 stainless steel housing with hermetic sealing and chemical-resistant gasketing, validated for repeated exposure to vaporized hydrogen peroxide (VHP) and 70% isopropyl alcohol (IPA) sterilization cycles without performance degradation or material corrosion.
• Onboard data integrity architecture: 2,000 sample records stored locally with dual-buffer redundancy; in the event of power loss or communication interruption, unsent data remains preserved and auto-resumes upload upon recovery—ensuring full audit trail continuity.
• Flexible power and integration: Supports Power over Ethernet (PoE) Class 3 (IEEE 802.3af), enabling single-cable deployment with hot-swap capability for maintenance without system shutdown; also compatible with DC 9–28 V or universal AC 100–240 V input.
• Industrial-grade I/O: Dual-mode digital communication via RS485 (Modbus RTU) and Ethernet (Modbus TCP/IP), plus isolated 4–20 mA analog outputs per channel—enabling seamless integration into SCADA, BMS, and MES platforms compliant with ISA-88/ISA-95 and FDA 21 CFR Part 11 data governance frameworks.

Sample Compatibility & Compliance

These counters are validated for use with externally supplied, filtered, and pressure-regulated air sources—eliminating internal pump-induced turbulence or particle shedding. The inlet design supports isokinetic sampling via included velocity-matched probe (equal-velocity sampling port), minimizing bias in laminar flow hoods and RABS. Calibration traceability is maintained per ISO 21501-4 using NIST-traceable PSL standards. Device firmware and configuration logs support ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and are compatible with electronic signature workflows required under GMP Annex 11 and EU GMP Chapter 4. All hardware and firmware revisions undergo formal change control documentation aligned with ICH Q9/Q10 risk management principles.

Software & Data Management

The 3718-A/3719-A operate autonomously but integrate natively with KANOMAX’s KAN-View™ Central Monitoring Software (sold separately), which provides multi-node visualization, configurable alarm thresholds (per particle size and location), trend analysis, and automated report generation (PDF/CSV) compliant with ISO 14644-2 surveillance requirements. Raw data export includes timestamped particle counts, flow status, sensor health flags, and diagnostic codes—structured to support CSV ingestion into LIMS or ELN systems. Audit trail functionality records all user-initiated parameter changes, calibration events, and alarm acknowledgments with operator ID and UTC timestamps—fully satisfying 21 CFR Part 11 §11.10(e) electronic record retention mandates.

Applications

• Continuous Grade A monitoring in isolators and RABS during aseptic filling operations.
• Automated environmental monitoring (EM) in cleanroom classification and requalification studies per ISO 14644-1 and EU GMP Annex 1.
• Real-time deviation detection during VHP decontamination cycle validation and post-cycle hold time verification.
• Integration into HVAC trending systems for proactive filter integrity assessment and airflow uniformity mapping.
• Support for compressed gas quality monitoring (e.g., nitrogen, CO₂) when paired with appropriate inline filtration and pressure regulation.

FAQ

What cleanroom classifications can the 3718-A and 3719-A support?
Both models are validated for ISO Class 3–8 (Federal Standard 209E Class 1–100,000) environments, with the 3718-A specifically optimized for ISO Class 3–5 (Grade A/B) due to its 0.3 µm sensitivity.
Is firmware upgrade supported remotely?
Yes—firmware updates can be deployed over Modbus TCP/IP or via USB-to-serial interface using KANOMAX’s certified update utility, with version rollback capability and SHA-256 integrity verification.
Does the device meet FDA 21 CFR Part 11 requirements for electronic records?
The instrument itself is Part 11–capable when used within a validated software ecosystem (e.g., KAN-View™ with audit trail enabled); standalone operation does not constitute a closed system per §11.30(a), but all data exports retain full traceability metadata.
Can the counter be installed inside a glovebox?
Yes—the 316 SS enclosure, IP65-rated ingress protection, and VHP resistance make it suitable for direct mounting inside ISO 5–7 classified gloveboxes, provided external air supply and thermal management are maintained.
What is the mean time between failures (MTBF) for the laser diode?
Based on accelerated life testing per IEC 62380, the laser source demonstrates ≥100,000 hours MTBF at rated operating conditions—equivalent to >11 years of continuous operation with no scheduled replacement.