Kanomax 3887D Handheld Laser Particle Counter for Cleanroom Environmental Monitoring
| Brand | Kanomax |
|---|---|
| Origin | Japan |
| Model | 3887D |
| Instrument Type | Handheld Particle Counter |
| Flow Rate | 2.83 L/min (0.1 cfm) |
| Flow Accuracy | < ±1 particle per 5 min |
| Timing Accuracy | ±1 s within 6-min sampling |
| Repeatability | ≤ ±10% FS |
| Size Distribution Error | ≤ ±30% |
| Indication Error | ≤ ±30% FS |
| Particle Size Channels | 0.3, 0.5, 1.0, 3.0, 5.0 µm |
| Sampling Duration | 10 sec – 99 min 59 sec |
| Data Storage Capacity | 7,000 records |
| Power Supply | 4×AA Ni-MH rechargeable batteries or AC adapter (100–240 V AC) |
| Dimensions | 108(W) × 68(D) × 196(H) mm |
| Weight | ~680 g (without batteries) |
| Compliance Standards | ISO 14644-1, GB/T 16292–2010, China GMP (2010) Annex 1 |
Overview
The Kanomax 3887D Handheld Laser Particle Counter is an optically engineered instrument designed for real-time airborne particulate monitoring in controlled environments—specifically cleanrooms used in pharmaceutical manufacturing, medical device assembly, semiconductor fabrication, and biotechnology laboratories. It operates on the principle of light scattering: aerosol particles drawn through a precisely calibrated laminar flow path intersect with a high-stability diode laser beam; scattered photons are detected by a photodiode sensor and classified into discrete size bins based on pulse amplitude calibration. With a nominal volumetric flow rate of 2.83 L/min (0.1 cfm), the 3887D meets the minimum sampling volume requirements defined in ISO 14644-1 for Class 5 (ISO Class 5) and higher cleanroom classifications. Its five-channel detection capability (0.3, 0.5, 1.0, 3.0, and 5.0 µm) enables simultaneous enumeration across critical size thresholds relevant to microbial carrier particles, filter integrity verification, and process contamination risk assessment.
Key Features
- Laser-based optical sensing system with factory-calibrated size discrimination traceable to NIST-traceable polystyrene latex (PSL) standards
- Integrated microprocessor-controlled sampling pump with closed-loop flow regulation ensuring stable 2.83 L/min delivery under variable backpressure conditions
- Full中文-language user interface optimized for operational efficiency in multilingual GMP facilities—no external translation required during routine qualification or audit support
- Seven operational modes: Single, Repeat, Continuous, Calculate (for derived metrics such as cumulative/differential counts), Remote (RS-232/USB), International (ISO-compliant reporting), and GMP (aligned with Annex 1 data structure)
- On-device delay-start function (0–999 sec) eliminates operator-induced perturbation at sample initiation, enhancing measurement reproducibility
- Non-volatile memory stores up to 7,000 complete test records—including timestamp, location ID, operator code, environmental parameters (optional via external sensors), and full-size distribution histograms
- Battery-operated portability (680 g, AA-based Ni-MH pack) supports walk-through mapping, ISO 14644-2 compliance verification, and HVAC commissioning without tethered power constraints
Sample Compatibility & Compliance
The 3887D is validated for use with ambient air, compressed gases (via optional pressure regulator and desiccant filter), and HEPA-filtered supply air streams typical of ISO Class 3–8 environments. It complies with the physical sampling and data reporting requirements of ISO 14644-1:2015 (Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness), GB/T 16292–2010 (Technical requirements for airborne particle testing in pharmaceutical clean areas), and China’s Good Manufacturing Practice (GMP) Annex 1 (2022 revision) for sterile medicinal products. While not inherently 21 CFR Part 11 compliant in standalone mode, its exported CSV and PDF reports—when generated via Kanomax’s optional PC software (Kanomax Data Manager v3.x)—support ALCOA+ principles when deployed within validated electronic record systems meeting FDA and EMA expectations for audit trails, electronic signatures, and data integrity controls.
Software & Data Management
Raw data export is supported via USB 2.0 or RS-232 serial interface to Kanomax Data Manager software (Windows-compatible). This application enables batch report generation conforming to ISO 14644-2 statistical sampling plans, trend analysis across multiple locations/timepoints, overlay of historical baselines, and automated pass/fail evaluation against preconfigured limits. All exported files include embedded metadata: instrument serial number, firmware version, calibration due date, operator ID, and GPS-tagged location (if enabled via paired Bluetooth module). Audit-ready logs capture all user-initiated actions—including parameter changes, data deletions, and report exports—with timestamps and account identifiers—facilitating GLP/GMP documentation and internal quality audits.
Applications
- Pre- and post-certification validation of cleanroom classification per ISO 14644-1 and EU GMP Annex 1
- In-process environmental monitoring (EPM) during aseptic filling, lyophilization, and isolator operations
- Filter leak testing (e.g., ULPA/HEPA integrity checks using upstream challenge and downstream scanning)
- HVAC system performance verification—including airflow uniformity, recovery time, and pressure cascade stability
- Root cause investigation of out-of-specification (OOS) microbiological results via correlation with concurrent particle excursions
- Supplier qualification of clean packaging materials and transfer hatches
- Training and competency assessment for cleanroom behavioral protocols
FAQ
What is the maximum allowable sampling duration per test cycle?
The instrument supports programmable sampling intervals from 10 seconds to 99 minutes and 59 seconds, configurable via the front-panel menu.
Does the 3887D require annual recalibration?
Yes. Kanomax recommends annual traceable recalibration against PSL reference standards at an accredited service center to maintain metrological validity per ISO/IEC 17025 requirements.
Can the device be used in compressed air lines?
Only with the optional Kanomax Compressed Air Sampling Kit (Model CA-3887), which includes pressure reduction, coalescing filtration, and isothermal expansion to prevent condensation-induced false counts.
Is the internal battery charger integrated into the AC adapter?
No. The AC adapter powers the unit only; batteries must be charged externally using the dedicated Kanomax BC-3887 charger to ensure cell longevity and safety compliance.
How does the instrument handle data loss during unexpected power interruption?
It features non-volatile flash memory with automatic save-on-power-loss functionality: any active measurement is preserved and resumes upon restart without manual intervention.
