Kanomax Model 3920 High-Flow Cleanroom Particle Counter
| Brand | Kanomax |
|---|---|
| Origin | Japan |
| Model | 3920 |
| Flow Rate | 100 L/min |
| Particle Size Channels | 0.5, 0.7, 1.0, 3.0, 5.0, 10.0 µm (simultaneous) |
| Counting Efficiency | ≥50% ±20% at 0.5 µm (ISO 21501-4 compliant) |
| Maximum Concentration | 300,000 particles/ft³ |
| Repeatability | ≤±10% FS |
| Size Resolution | <15% at 0.5 µm (ISO 21501-4) |
| Flow Accuracy | <1 particle deviation per 5 min |
| Timing Accuracy | <±30% FS |
| Indication Error | <±30% FS |
| Data Storage | 10,000 measurement sets with geotagging (map coding) |
| Compliance | ISO 14644-1:2015, ISO 14644-2015, EU GMP Annex 1, USP <788>, FDA 21 CFR Part 11 (audit trail & electronic signature support), GB/T 16292–2010, GB 50333–2013, BS 5295, Federal Standard 209E |
Overview
The Kanomax Model 3920 is a high-flow, dual-channel laser diode-based optical particle counter engineered for quantitative airborne particulate monitoring in critical controlled environments. Operating on the principle of light scattering detection—where individual particles passing through a focused 650 nm laser beam generate scattered photons proportional to their size—the instrument delivers real-time, multi-size bin counting at a nominal volumetric flow rate of 100 L/min. This high-flow capability enables statistically robust sampling in large-volume cleanrooms (e.g., ISO Class 5–8 spaces per ISO 14644-1:2015), significantly reducing test duration compared to conventional 28.3 L/min or 50 L/min instruments. Its design adheres strictly to ISO 21501-4 for calibration traceability, ensuring metrological consistency across global manufacturing and regulatory frameworks. The 3920 is not a portable survey tool but a laboratory-grade, fixed-installation or mobile cart-deployed instrument intended for routine qualification, periodic surveillance, and compliance verification in semiconductor fabrication facilities, pharmaceutical aseptic processing suites, and medical device assembly clean zones.
Key Features
- High-flow sampling at 100 L/min with integrated mass flow control and real-time flow monitoring—ensuring adherence to ISO 14644-1 sampling volume requirements for ≥ISO Class 5 environments.
- Six simultaneous, user-selectable particle size channels: standard configuration includes 0.5, 0.7, 1.0, 3.0, 5.0, and 10.0 µm; optional customization supports any six sizes within 0.5–10.0 µm range.
- 6.4-inch full-color resistive touchscreen interface with bilingual (English/Chinese) UI, supporting both local operation and remote GUI access via Ethernet.
- Onboard thermal printer for immediate hard-copy generation of test reports—including timestamp, location code, particle counts per channel, and pass/fail status against ISO or GMP limits.
- Dual hot-swappable lithium-ion battery modules enabling continuous operation for >4 hours (typical); AC adapter included for benchtop or wall-mounted deployment.
- Robust stainless-steel housing rated IP54 for resistance to cleaning agents and mechanical abrasion in ISO 7–8 gowning rooms and equipment corridors.
- Built-in audit trail functionality compliant with FDA 21 CFR Part 11, including electronic signatures, operator ID logging, and immutable record timestamps.
Sample Compatibility & Compliance
The Model 3920 is validated for use with isokinetic sampling probes and conductive polyurethane tubing (2 m standard length) to minimize electrostatic particle loss during aspiration. It supports integration with external environmental sensors—such as calibrated anemometers (for ISO 14644-3 airflow uniformity testing), thermohygrometers, and differential pressure transducers—enabling synchronized multi-parameter data acquisition. Regulatory alignment includes full conformance with ISO 14644-1:2015 Annex B (sampling plan logic), ISO 14644-2:2015 (monitoring frequency requirements), EU GMP Annex 1 (2022 revision) for sterile manufacturing, USP for injectables, and China’s GB/T 16292–2010 and GB 50333–2013 standards for hospital and pharmaceutical cleanrooms. All firmware and calibration certificates are traceable to NMIJ/AIST (Japan) and include uncertainty budgets per ISO/IEC 17025.
Software & Data Management
Data from the 3920 is stored internally in a secure, non-volatile memory array supporting up to 10,000 discrete measurement records—each tagged with map-coded location identifiers (001–999), operator ID, and environmental metadata. Export occurs via USB 2.0 or 10/100BASE-T Ethernet to Kanomax’s proprietary Cleanroom Manager software (Windows-compatible), which generates ISO-compliant statistical summaries, trend charts, and deviation alerts. The system enforces role-based access control (RBAC), automatic backup scheduling, and encrypted data transfer. For enterprise integration, it supports OPC UA and Modbus TCP protocols, enabling direct ingestion into MES, SCADA, or LIMS platforms under 21 CFR Part 11 and Annex 11 validation protocols.
Applications
- ISO classification and re-certification of semiconductor photolithography bays, wafer inspection labs, and advanced packaging cleanrooms.
- HEPA/ULPA filter integrity testing via upstream/downstream scanning in accordance with IEST-RP-CC034.2 and ISO 14644-3.
- Continuous environmental monitoring (CEM) in Grade A/B pharmaceutical isolators and filling lines per EU GMP Annex 1 §8.42–8.48.
- Validation of laminar airflow workstations (LAFWs), biosafety cabinets (BSCs), and gloveboxes used in cell therapy and mRNA vaccine production.
- Root cause analysis of particulate excursions during process qualification studies—leveraging time-synchronized particle burst detection and spatial mapping.
- Supporting ISO 14644-2 surveillance plans through automated interval sampling with configurable alarm thresholds and email/SNMP notifications.
FAQ
Does the Model 3920 meet FDA 21 CFR Part 11 requirements for electronic records and signatures?
Yes. It provides full audit trail logging, operator authentication, electronic signature capture, and data immutability—validated for use in regulated pharmaceutical and medical device quality systems.
Can the instrument be calibrated in-house using NIST-traceable reference aerosols?
No. Calibration must be performed by Kanomax-authorized service centers using PSL (polystyrene latex) standards traceable to NMIJ, with certificate of calibration issued per ISO/IEC 17025.
What is the maximum allowable particle concentration before coincidence error exceeds specification?
The upper limit is 300,000 particles per cubic foot (10.6 million/m³) at 0.5 µm, beyond which statistical correction algorithms apply per ISO 21501-4 Annex D.
Is the thermal printer compatible with GLP/GMP-controlled document retention policies?
Yes. Printed reports include unique serial number, calibration due date, operator ID, and ISO-compliant header/footer fields—fully auditable for regulatory inspections.
How does the 3920 handle sampling in low-humidity environments where electrostatic particle adhesion may occur?
It incorporates grounded conductive sampling tubing and internal static-dissipative flow path design, minimizing losses below 30% RH—verified per ISO 21501-4 Annex F.
