Kanomax 3887Pro Handheld Optical Particle Counter

Overview

The Kanomax 3887Pro Handheld Optical Particle Counter is an ISO 21501-4 and JIS B9921 compliant portable instrument engineered for high-fidelity airborne particulate monitoring in cleanroom validation, HVAC performance verification, and controlled environment qualification. It employs a calibrated laser diode light source and forward-scatter optical detection to quantify discrete particle events across five discrete size channels: 0.3, 0.5, 1.0, 3.0, and 5.0 µm. With a nominal volumetric flow rate of 2.83 L/min (±5%), the device delivers traceable, repeatable measurements suitable for compliance with ISO 14644-1, GB/T 16292–2010, and China’s revised Good Manufacturing Practice (GMP) Annex 1 requirements for sterile manufacturing environments. Its compact form factor (87 × 200 × 55 mm), integrated rechargeable lithium-ion battery (rated for ~5 hours of continuous operation), and ergonomic handheld design enable rapid point-of-use sampling without external pumps or fixed infrastructure—making it ideal for mobile audits, facility mapping, and routine environmental monitoring across semiconductor fabrication, pharmaceutical aseptic processing, and medical device manufacturing.

Key Features

• Laser-based optical sensing with certified counting efficiency per ISO 21501-4 and JIS B9921, ensuring metrological traceability to international standards.
• Simultaneous real-time detection and classification across five particle size bins (0.3, 0.5, 1.0, 3.0, 5.0 µm), supporting both differential and cumulative count reporting.
• 3.5-inch resistive touchscreen interface with intuitive icon-driven navigation—enabling on-device configuration of sampling parameters including duration (6 sec–99:59 min), interval time, and total sample count (1–999 or continuous).
• Robust data integrity architecture: automatic resumption of interrupted GB or ISO-compliant test sequences following power loss or system reset; no data corruption or session truncation.
• Onboard storage for up to 7,000 complete measurement records, each timestamped and tagged with location metadata (user-defined site ID), with built-in statistical functions (min/max/mean) per channel.
• Dual communication protocol support (USB 2.0 and RS485) for flexible integration into laboratory information management systems (LIMS), SCADA platforms, or dedicated particle monitoring networks.

Sample Compatibility & Compliance

The 3887Pro is validated for use with ambient air and compressed gases (filtered to ≤0.1 µm) in non-corrosive, non-explosive environments. It is not intended for aerosolized liquids, oil mists, or highly hygroscopic particulates that may cause optical window fouling or sensor drift. All factory calibrations are performed using NIST-traceable PSL (polystyrene latex) reference particles and documented in the included calibration report. The instrument meets electromagnetic compatibility (EMC) requirements per IEC 61326-1 and safety specifications under IEC 61010-1. Its measurement methodology and reporting structure align with regulatory expectations for environmental monitoring under FDA 21 CFR Part 11 (when used with validated software), EU GMP Annex 1, and ISO/IEC 17025-accredited laboratories conducting cleanroom certification.

Software & Data Management

Kanomax provides dedicated PC-based analysis software compatible with Windows 10/11. The application supports secure import of raw .csv or proprietary binary logs via USB or RS485, enabling dynamic time-series visualization, statistical trend analysis, and automated report generation—including ISO 14644-1 class conformity assessment tables. Audit trail functionality logs all user actions (e.g., parameter changes, data exports, report generation) with timestamps and operator IDs. Export formats include PDF (print-ready), Excel (.xlsx), and XML for downstream LIMS ingestion. Software validation documentation (IQ/OQ protocols) is available upon request for regulated users requiring formal system qualification.

Applications

• Cleanroom classification and re-certification per ISO 14644-1 Class 3–9 and GB/T 16292–2010 Grade A–D environments.
• Aseptic processing line monitoring in pharmaceutical and biotech facilities during media fills and operational qualification (OQ).
• HEPA/ULPA filter integrity testing and leak detection in laminar flow hoods, isolators, and RABS.
• Environmental baseline establishment and trending in semiconductor clean fabs, LCD panel production, and precision optics assembly.
• Post-maintenance verification of HVAC filtration efficiency and airflow uniformity in hospital operating rooms and isolation wards.
• Research-grade particulate exposure assessment in academic cleanroom laboratories and aerospace contamination control studies.

FAQ

What standards does the 3887Pro comply with for particle counting accuracy?
It conforms to ISO 21501-4 (calibration and counting efficiency), JIS B9921 (Japanese national standard), and supports reporting formats required by ISO 14644-1, GB/T 16292–2010, and China GMP Annex 1.
Can the device operate independently without a computer?
Yes—the 3887Pro performs fully autonomous sampling, data logging, and on-screen result display. A PC is only required for advanced analysis, report generation, or firmware updates.
Is the battery replaceable by the end user?
No—the sealed Li-ion battery is field-replaceable only by authorized Kanomax service centers to maintain IP rating and calibration integrity.
Does the instrument support external trigger inputs or analog outputs?
Not natively—the 3887Pro offers digital communication only via USB and RS485. Analog output or TTL triggering requires third-party interface hardware.
How is data security ensured during transfer and storage?
Data files are stored in non-encrypted but structured binary or CSV format; full 21 CFR Part 11 compliance requires implementation of validated software controls, electronic signatures, and audit trails—available through Kanomax’s optional software package and associated validation services.