Kanomax 3905 High-Flow Cleanroom Particle Counter for Pharmaceutical Applications

Overview

The Kanomax 3905 High-Flow Cleanroom Particle Counter is an ISO 21501-4 compliant, laser-diode-based optical particle counter engineered for rigorous environmental monitoring in regulated pharmaceutical manufacturing environments. Designed specifically for ISO Class 5–8 cleanrooms and critical aseptic processing zones, the instrument employs light scattering principles to detect and size airborne particulates across six user-selectable channels (standard: 0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm). Its calibrated 28.3 L/min volumetric flow rate enables statistically robust sampling per ISO 14644-1:2015 requirements—reducing measurement uncertainty and minimizing required sampling duration for qualification and routine surveillance. The device meets the metrological traceability and performance validation criteria defined in JJF 1190–2008 (Chinese national calibration specification) and aligns with global regulatory expectations for data integrity under FDA 21 CFR Part 11 and EU GMP Annex 1.

Key Features

• Laser diode light source with stable output and documented lifetime (>3 years warranty on emitter)
• High-flow sampling at 28.3 L/min with flow accuracy <±1% over 5-minute intervals and timing precision <±1 second per 6-minute acquisition
• Six simultaneous particle size channels configurable within 0.3–10.0 µm range; supports non-standard channel selection per user-defined protocols
• 6.4-inch capacitive touchscreen interface with intuitive navigation, multilingual UI (English/Chinese), and real-time graphical display of concentration trends
• Onboard thermal printer for immediate hard-copy generation of ISO-compliant test reports—including pass/fail evaluation against selected cleanroom class limits (e.g., ISO 5, ISO 7)
• Integrated rechargeable dual-battery system enabling continuous operation up to 4 hours; AC adapter included for lab or fixed-location use
• Expandable data storage: internal memory holds 10,000 sample records; USB port supports external flash drives for archival transfer and backup
• Comprehensive error diagnostics including flow deviation, laser intensity drift, sensor saturation, and zero-count verification per JIS B 9921

Sample Compatibility & Compliance

The Kanomax 3905 is validated for use in controlled environments where particulate contamination directly impacts product sterility and process reliability. It complies with ISO 14644-1:2015 (cleanroom classification), ISO 14644-2:2015 (monitoring requirements), and national standards GB/T 16292–2010 and GB 50333–2013. Instrument performance adheres to ISO 21501-4 for optical particle counter calibration, including counting efficiency (50% ±20% at 0.3 µm), size resolution (<15% at 0.3 µm), and false count rate (<0.2 particles/ft³). Optional environmental sensors (temperature, RH, differential pressure, air velocity) extend monitoring capability without requiring separate instrumentation—supporting holistic environmental qualification per EU GMP Annex 1 §4.35–4.42. All firmware and software modules are designed to support ALCOA+ data integrity principles and facilitate audit readiness for FDA, EMA, and NMPA inspections.

Software & Data Management

Data acquisition, analysis, and reporting are managed through embedded firmware with configurable sampling modes: single-shot, timed interval, or continuous logging. Each stored record includes timestamp, location ID, operator ID, environmental conditions (when sensors attached), and raw channel counts. Export formats include CSV and PDF for integration into LIMS or quality management systems. The instrument supports 21 CFR Part 11 compliance features including electronic signatures, role-based access control, and immutable audit trails for all configuration changes, report generation, and data deletion events. Firmware updates are delivered via USB or Ethernet, with version history and cryptographic checksums provided for validation. Calibration logs, maintenance records, and certificate of conformance are retained within the device’s secure memory partition.

Applications

• Qualification and periodic requalification of Grade A/B/C/D cleanrooms per EU GMP Annex 1 and USP
• In-process monitoring during aseptic filling, lyophilization, and isolator operations
• Filter integrity verification and HEPA/ULPA leak testing using isokinetic sampling probes
• Environmental baseline establishment and trend analysis for CAPA initiation
• Supporting risk-based monitoring strategies aligned with ICH Q9 and Q10 frameworks
• Validation of gowning procedures, equipment sterilization cycles, and material transfer protocols

FAQ

Does the Kanomax 3905 meet FDA 21 CFR Part 11 requirements for electronic records?
Yes—the device implements electronic signature workflows, audit trail logging, and role-based user authentication to satisfy Part 11 Subpart B controls.
Can the instrument be used for ISO Class 4 or higher洁净区 (e.g., laminar flow hoods)?
While optimized for ISO Class 5–8, the 3905 may be deployed in Grade A zones when paired with isokinetic sampling probes and validated per ISO 14644-3 Annex B; however, lower-flow instruments (e.g., 3910/3920) are typically preferred for ultra-low concentration environments.
Is calibration traceable to NIST or other national metrology institutes?
Yes—factory calibration uses NIST-traceable PSL reference aerosols; users receive a Certificate of Conformance with uncertainty budget per ISO/IEC 17025 guidelines.
What is the maximum allowable particle concentration before coincidence loss affects accuracy?
The upper limit is 500,000 particles/ft³ (17.6 × 10⁶ particles/m³); above this, statistical correction or dilution is required per ISO 21501-4 Section 6.4.
How is temperature and humidity compensation handled during particle counting?
The optional integrated environmental sensor provides real-time correction factors applied to flow rate and density calculations—ensuring volumetric accuracy across operating ranges of 10–40°C and 20–80% RH.