Kanomax Model 3910 High-Flow Cleanroom Particle Counter for Pharmaceutical Grade Environmental Monitoring

Overview

The Kanomax Model 3910 is a high-flow, dual-channel laser diode-based airborne particle counter engineered for rigorous environmental monitoring in regulated pharmaceutical manufacturing environments. It operates on the principle of light scattering—where particles drawn through a calibrated laminar airflow intersect a focused 650 nm laser beam, generating scattered photons detected by a high-sensitivity photodetector array. Signal pulse height analysis enables real-time classification and counting across six user-selectable size thresholds (standard: 0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm), with resolution validated to ISO 21501-4 (<15% coincidence loss at 150,000 particles/ft³). Its 50 L/min volumetric flow rate satisfies ISO 14644-1:2015 minimum sampling volume requirements for Class 5 (ISO 5) and tighter cleanroom classifications—reducing measurement time by up to 76% compared to conventional 28.3 L/min instruments while maintaining metrological traceability.

Key Features

• High-flow sampling at 50 L/min with flow stability maintained within ±1 particle deviation per 5-minute interval—critical for statistically robust data acquisition in large-volume cleanrooms and isolators.
• Laser diode excitation source with ≥3-year rated lifetime and integrated zero-count verification using certified HEPA-filtered air—ensuring baseline integrity prior to each sampling sequence.
• True-color 6.4-inch resistive touchscreen interface supporting multi-language operation (English & Chinese), intuitive navigation, and real-time graphical display of concentration trends and alarm status.
• Built-in thermal printer enabling immediate hardcopy generation of ISO-compliant test reports—including date/time stamp, location ID, operator name, and pass/fail evaluation against ISO 14644-1 or EU GMP Annex 1 limits.
• Dual hot-swappable Li-ion battery modules providing >4 hours continuous operation; AC adapter support (100–240 V, 50–60 Hz) for extended stationary use.
• Expandable storage architecture: internal non-volatile memory holds 10,000 full-sample records (including timestamp, location code, raw channel counts, and environmental metadata); USB host port supports external flash drives for archival export and firmware updates.

Sample Compatibility & Compliance

The Model 3910 is designed exclusively for ambient and controlled environment air sampling—not for aggressive aerosols, corrosive gases, or explosive atmospheres. It meets the optical and electronic performance criteria defined in ISO 21501-4:2018 (calibration and verification of light-scattering airborne particle counters) and complies with the operational validation requirements of ISO 14644-1:2015 (cleanroom classification), ISO 14644-2:2015 (monitoring), and GB/T 16292–2010 (Chinese pharmaceutical cleanroom standards). All firmware and data handling routines are configured to satisfy 21 CFR Part 11 regulatory expectations—including electronic signature capability, audit trail logging (user actions, parameter changes, report generation), and data immutability upon finalization. Calibration certificates are NIST-traceable and issued per JJF 1190–2008 (Chinese national metrological verification regulation for particle counters).

Software & Data Management

Data collection and reporting are managed through Kanomax’s proprietary KAN-View software suite (included), which supports Windows OS platforms and facilitates bidirectional communication via Ethernet or USB. The software enables batch import/export of CSV and PDF reports, customizable location mapping (up to 999 site IDs), statistical analysis (mean, SD, UCL calculation per ISO 14644-2), and automated comparison against configurable ISO or GMP class thresholds. Audit trails record all user-initiated events—including login/logout timestamps, configuration modifications, and report approvals—with tamper-evident hashing. Raw data files are stored in encrypted binary format and can be exported in comma-delimited ASCII for integration into LIMS or MES systems.

Applications

• Qualification and routine monitoring of ISO Class 5–8 cleanrooms, aseptic processing suites, and RABS/Isolator systems per EU GMP Annex 1 (2022 revision) and FDA Aseptic Processing Guidance.
• Filter integrity verification (e.g., post-PAO challenge testing of HEPA/ULPA units) when paired with optional scanning probe and isokinetic sampling head.
• Environmental monitoring during media fill simulations and process validation campaigns—supporting statistical process control (SPC) and trend analysis over time.
• Compliance-driven investigations following excursion events, including root cause assessment via temporal correlation with temperature, humidity, differential pressure, and air velocity data (when connected to optional external sensors).
• Supporting ISO 14644-2 surveillance plans requiring scheduled, location-specific particle concentration trending with upper confidence limit (UCL) calculations.

FAQ

Does the Model 3910 meet FDA 21 CFR Part 11 requirements for electronic records and signatures?

Yes—the instrument firmware and bundled KAN-View software implement role-based access control, electronic signature workflows, and immutable audit trails aligned with Part 11 Subpart B expectations.
Can the device perform real-time pass/fail classification against ISO 14644-1 limits?

Yes—users may define location-specific acceptance criteria per particle size channel; the system evaluates and displays compliance status immediately after sampling completion.
What is the maximum allowable particle concentration before coincidence error exceeds specification?

The counter maintains <5% coincidence loss up to 150,000 particles/ft³ (5.3×10⁶ particles/m³) at 0.3 µm, per ISO 21501-4 Clause 6.3.3.
Is external sensor integration limited to Kanomax-branded probes?

No—while Kanomax environmental sensors (temperature/humidity, differential pressure, anemometer) are fully auto-recognized, third-party analog or digital sensors with standard 0–5 V or RS-485 output may be integrated via custom configuration.
How is calibration traceability documented for audit purposes?

Each unit ships with a factory calibration certificate referencing NIST-traceable reference aerosols (e.g., PSL spheres) and includes space for field recalibration logs compliant with ISO/IEC 17025 and ISO 14644-3 Annex D.