Kanomax 3887L Handheld Airborne Particle Counter

Overview

The Kanomax 3887L Handheld Airborne Particle Counter is a compact, field-deployable optical particle counter engineered for rapid, on-site monitoring of airborne particulate contamination in cleanrooms, controlled environments, and HVAC validation workflows. It operates on the principle of light scattering—where aerosol particles drawn through a calibrated laminar flow path intersect a focused laser beam, generating scattered light pulses proportional to particle size and count. The instrument is configured with dual-channel detection at 0.5 µm and 5.0 µm, enabling compliance-aligned assessment of both viable and non-viable particulate thresholds per ISO 14644-1:2015, GB/T 16292–2010, and Annex 1 (2022) requirements for pharmaceutical manufacturing environments. Its fixed flow rate of 2.83 L/min (0.1 cfm) ensures consistent volumetric sampling across measurements, minimizing variability associated with flow drift—a critical factor in regulatory-grade environmental monitoring.

Key Features

• Optimized dual-channel optical sensing for simultaneous counting at 0.5 µm and 5.0 µm—aligned with ISO Class 5–8 and GMP Grade A–D classification protocols.
• High-stability airflow system with verified flow accuracy (<1 particle deviation per 5 minutes), validated against NIST-traceable flow standards.
• Real-time timing control: ±1 second accuracy over 6-minute sampling intervals, supporting precise adherence to ISO 14644-1 minimum sampling time requirements.
• Integrated data logging with 10,000-sample memory capacity, including timestamp, location tag (user-defined), channel-specific counts, and sampling duration.
• Backlit LCD display with adjustable contrast for operation under low-illumination conditions typical of cleanroom gowning areas or utility corridors.
• Power-flexible operation: supports alkaline, rechargeable Ni-MH AA cells, or universal AC input (100–240 V), with automatic power-loss recovery and resume-on-power restoration.
• Ergonomic handheld form factor (108 × 68 × 196 mm; ~680 g) designed for extended operator use during multi-point mapping or routine surveillance.

Sample Compatibility & Compliance

The 3887L is intended for use with ambient air, filtered process air, and compressed gas streams (when equipped with appropriate inlet conditioning). It does not support liquid-phase or oil-mist sampling. All measurement outputs conform to ISO 21501-4:2018 for calibration traceability and performance verification of light-scattering airborne particle counters. Built-in test modes—including GBMODE, GMP, and ISO-compliant sampling sequences—automatically apply required dwell times, averaging logic, and pass/fail evaluation per selected standard. Device firmware and data output structures are compatible with GLP/GMP documentation workflows, supporting audit-ready export via USB interface (CSV format) with full metadata retention.

Software & Data Management

Data retrieval is performed via USB 2.0 connection to Windows-based PCs using Kanomax’s proprietary KAN-PC software (v3.0+), which enables batch export, statistical summary (mean, SD, UCL), spatial mapping overlay, and report generation compliant with FDA 21 CFR Part 11 requirements when used with validated configurations. Audit trail functionality includes user login timestamps, parameter modification logs, and sample deletion records—all stored locally on-device and exportable. No cloud connectivity or remote firmware updates are supported, preserving data sovereignty and network isolation in regulated facilities.

Applications

• Cleanroom certification and periodic requalification per ISO 14644-2:2015 and EU GMP Annex 1.
• Environmental monitoring (EM) programs in sterile manufacturing suites, isolators, and RABS.
• HVAC filter integrity verification and airflow visualization studies.
• Pharmaceutical QC laboratories conducting media fill environmental challenge assessments.
• Microelectronics fabrication facilities requiring sub-micron particle surveillance at tool interfaces.
• Research institutions performing aerosol transport modeling and filtration efficiency benchmarking.

FAQ

Does the 3887L support 0.3 µm particle detection?
No—the 3887L is factory-configured exclusively for 0.5 µm and 5.0 µm channels. For 0.3 µm capability, consider the Kanomax 3887C or 3888 series.
Can the device be used in high-humidity environments?
Operation is rated up to 80% relative humidity (non-condensing); prolonged exposure above this threshold may affect optical window clarity and sensor stability.
Is the internal clock battery-backed?
Yes—the real-time clock retains time/date settings for up to 72 hours after main power loss, ensuring continuity in long-term unattended sampling.
How is calibration maintained between service intervals?
Users must perform daily zero-count verification using HEPA-filtered air and scheduled annual calibration per ISO 21501-4 by an accredited third-party laboratory or Kanomax-authorized service center.
Does the 3887L meet FDA 21 CFR Part 11 requirements out-of-the-box?
The hardware and firmware support Part 11 elements (electronic signatures, audit trails, data integrity controls); however, full compliance requires site-specific validation of the entire data acquisition and review workflow—including software configuration, access controls, and backup procedures.