Kanomax 3887C Handheld Airborne Particle Counter for Pharmaceutical Cleanroom Monitoring

Overview

The Kanomax 3887C is a handheld airborne particle counter engineered for precise, real-time monitoring of particulate contamination in controlled pharmaceutical environments—including cleanrooms, isolators, laminar flow hoods, and aseptic processing areas. It operates on the principle of light scattering (laser diode-based optical sensing), where airborne particles passing through a focused laser beam generate scattered light pulses proportional to their size. These pulses are classified into user-selectable channels (0.3, 0.5, and 5.0 µm) to meet critical regulatory thresholds defined by ISO 14644-1 Class 5–8, GB/T 16292–2010, and China’s Good Manufacturing Practice (GMP) Annex 1 requirements for sterile product manufacturing. With a calibrated volumetric sampling flow rate of 2.83 L/min (0.1 cfm), the 3887C delivers statistically valid data for ISO-compliant classification and routine operational qualification (OQ) of cleanspaces.

Key Features

• Laser-based optical particle detection with high signal-to-noise ratio and minimal coincidence error at typical cleanroom concentrations.
• Three user-selectable particle size channels (0.3 µm, 0.5 µm, 5.0 µm) aligned with ISO 14644-1 and China GMP reporting requirements.
• Configurable test protocols: Single-point, repeated sampling, continuous logging, calculated averages, remote operation (via optional RS-232 interface), and ISO mode for automatic classification reporting.
• Programmable delay start (0–999 sec) to eliminate operator-induced turbulence during probe placement.
• Non-volatile memory storing up to 7,000 measurement records with timestamp, location ID, and channel-specific counts.
• Automatic power-save and uninterruptible sampling: battery-level-triggered auto-save ensures no data loss during unexpected shutdown; resumes from last point upon restart.
• Robust ergonomic housing (108 × 68 × 196 mm, ~680 g) designed for extended handheld use and glove-compatible operation in ISO Class 5 gowning zones.

Sample Compatibility & Compliance

The 3887C is validated for use in non-hazardous, ambient-temperature indoor air environments (10–35°C, <80% RH non-condensing). It complies with international cleanroom monitoring standards including ISO 14644-1:2015 (Annex B for instrument calibration traceability), GB/T 16292–2010 (Chinese national standard for pharmaceutical cleanroom testing), and China GMP (2010) Annex 1 §4.16–4.19 regarding environmental monitoring frequency, alert/action limits, and data integrity. While not intrinsically safe for explosive atmospheres, its design meets IEC 61010-1 safety requirements for portable electrical measuring equipment. Calibration certificates (traceable to NIM or equivalent national metrology institutes) are available upon request for audit readiness under FDA 21 CFR Part 11 and EU Annex 11 compliance frameworks.

Software & Data Management

Data export is supported via RS-232 serial interface (cable included) to Kanomax’s proprietary PC software (Kanomax Data Manager v3.x), enabling batch download, graphical trend analysis, report generation (PDF/CSV), and customizable pass/fail evaluation against pre-set ISO or GMP limits. The software supports electronic signature workflows, audit trail logging (user actions, timestamps, parameter changes), and export formats compatible with LIMS integration. All stored measurements include metadata: date/time, operator ID, sampling location tag, duration, flow verification status, and battery level—ensuring full ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) data governance for GLP/GMP-regulated facilities.

Applications

• ISO 14644-1 cleanroom classification and re-certification (e.g., Grade A/B/C/D zones).
• Environmental monitoring (EM) programs per China GMP Annex 1 for viable and non-viable particle surveillance.
• Filter integrity verification (HEPA/ULPA) via upstream/downstream challenge testing.
• Process simulation support (media fill, component assembly) with real-time particulate trending.
• Validation of laminar airflow devices, isolators, and RABS systems.
• Root cause analysis of excursion events through time-synchronized multi-location particle mapping.

FAQ

Is the 3887C compliant with FDA 21 CFR Part 11 for electronic records?
Yes—when used with Kanomax Data Manager v3.x and configured with user authentication, audit trails, and electronic signatures, it satisfies core Part 11 requirements for closed systems.
Can the device be calibrated traceably to international standards?
Yes—factory calibration is traceable to NIM (National Institute of Metrology, China); accredited third-party calibration services (ISO/IEC 17025) are available globally.
Does the 3887C support 1.0 µm and 3.0 µm channels?
No—the 3887C model supports only 0.3 µm, 0.5 µm, and 5.0 µm channels; the 3887D variant adds 1.0 µm and 3.0 µm detection capability.
What is the recommended recalibration interval?
Annual recalibration is advised per ISO 21501-4 and manufacturer guidelines, or after any physical impact, firmware update, or performance deviation exceeding ±5% of reference value.
Can the unit operate while charging?
No—Ni-MH batteries must be charged externally using the dedicated Kanomax BC-3887 charger; AC adapter powers the unit but does not charge batteries in situ.