Kanomax Model 3910 High-Flow Cleanroom Particle Counter for Medical Operating Room Certification

Overview

The Kanomax Model 3910 is a high-flow, ISO 21501-4 compliant optical particle counter engineered for regulatory-grade airborne particulate monitoring in critical environments—particularly sterile medical operating rooms, pharmaceutical cleanrooms, and aseptic manufacturing suites. Utilizing a calibrated laser diode light source and a precision photodetector system, the instrument operates on the principle of single-particle light scattering (SPLS) to detect and size individual particles in real time. With a nominal volumetric flow rate of 50 L/min, it delivers statistically robust sampling in accordance with ISO 14644-1:2015 minimum sampling volume requirements for Class 5 (ISO 5) through Class 8 (ISO 8) environments. Its six-channel simultaneous detection across 0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm enables full compliance with both EU GMP Annex 1 and China’s GB 50333–2013 surgical suite classification protocols. The device is validated for use in GLP- and GMP-regulated settings where traceable, auditable, and repeatable data are mandatory.

Key Features

• High-flow sampling at 50 L/min ensures rapid acquisition of statistically significant particle counts per ISO 14644-1 sampling plans—reducing test duration by up to 75% compared to conventional 28.3 L/min instruments.
• Six fixed-size channels (0.3, 0.5, 1.0, 3.0, 5.0, 10.0 µm) aligned with international cleanroom classification standards; optional user-defined sizing within 0.3–10.0 µm range.
• Integrated 6.4-inch true-color capacitive touchscreen interface supports intuitive navigation, real-time histogram visualization, and on-device pass/fail evaluation against ISO 14644-1 or GB/T 16292–2010 limits.
• Built-in thermal printer generates immediate, timestamped, and signature-ready reports—including location ID, sampling duration, environmental parameters (when external sensors attached), and compliance status.
• Dual hot-swappable rechargeable Li-ion batteries enable uninterrupted operation for >4 hours (typical); AC adapter included for continuous benchtop use.
• Full 21 CFR Part 11 compliance architecture: electronic signatures, audit trail logging, user access levels (admin/operator), and secure data export via encrypted USB or Ethernet.

Sample Compatibility & Compliance

The Model 3910 is designed exclusively for airborne particulate sampling in controlled environments. It accepts standard isokinetic sampling probes and accommodates optional accessories—including differential pressure, temperature/humidity, and air velocity sensors—for concurrent environmental parameter logging. All counting performance metrics meet or exceed ISO 21501-4:2018 requirements for calibration, counting efficiency, false count rate (<0.2 particles/ft³), and zero-count stability (JIS B 9921). Certificates of conformance are supplied with each unit, referencing traceable NIST-traceable calibration at accredited third-party labs. The instrument satisfies mandatory validation criteria under EU GMP Annex 1 (2022), FDA Guidance for Aseptic Processing (2004), and China’s JJF 1190–2008 verification regulation for particle counters used in healthcare facility certification.

Software & Data Management

Data integrity is enforced through embedded firmware supporting ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Each stored record includes metadata: operator ID, location tag, sampling start/stop timestamps, flow verification logs, and sensor calibration status. Up to 10,000 sample sets are retained internally; additional storage is achieved via password-protected USB mass storage export—formatted in CSV and PDF report bundles compatible with LIMS integration. Optional Kanomax KAN-PC software (Windows-based) enables advanced statistical analysis, spatial mapping of particle distribution across multiple sampling points, and automated generation of ISO 14644-2 trend reports including recovery time and contamination event correlation.

Applications

• Certification and routine monitoring of ISO Class 5–8 operating rooms per GB 50333–2013 and JCI standards.
• Qualification of HVAC filtration efficiency and room pressurization integrity during commissioning and requalification.
• Environmental monitoring in sterile drug manufacturing (e.g., injectables, ophthalmics) under EU GMP Annex 1 and USP .
• Validation of isolator and RABS performance during media fill simulations.
• Root cause analysis of microbial excursion events through temporal correlation of particle spikes with viable air sampling results.
• Supporting ISO 14644-2 surveillance testing for continued compliance with operational limits.

FAQ

Does the Model 3910 support remote data retrieval via Ethernet?
Yes—the device features a 10/100BASE-TX Ethernet port enabling TCP/IP communication, secure FTP upload, and integration into centralized cleanroom monitoring systems.
Is calibration traceable to national standards?
Each unit ships with a factory calibration certificate traceable to NIST via A2LA-accredited laboratories; annual recalibration is recommended per ISO/IEC 17025 guidelines.
Can the instrument be used for compressed gas testing?
No—it is configured for ambient air sampling only; for compressed gas applications, Kanomax recommends the Model 3887 with dedicated pressure regulation and dilution modules.
What is the maximum allowable particle concentration for valid measurement?
The upper limit is 300,000 particles/ft³ (10.6 million/m³) at 0.5 µm; concentrations exceeding this require dilution or alternate sampling strategies per ISO 21501-4 Clause 6.4.
How does the device handle sampling in low-humidity environments?
The internal flow path is temperature- and humidity-stabilized; however, for environments below 20% RH, use of an isokinetic probe with anti-static coating is advised to minimize electrostatic particle loss.