MET ONE 3400 Portable Air Particle Counter

The MET ONE 3400 Series is the easiest and most reliable portable air particle counting solution for a wide variety of cleanroom applications—from aseptic production and process troubleshooting to continuous monitoring, classification and validation. Complete your cleanroom work quickly, confidently, and securely in compliance with ISO 14644, 21 CFR Part 11, and EU GMP Annex 1 requirements.

  • Industry’s first embedded secure data transfer for 21 CFR Part 11 compliance
  • Sample plan wizard for 14644 & Annex 1 compliance
  • Supports ISO 21501-4 compliance for unit-to-unit accuracy & reproducibility
  • One-touch sampling & location ID
  • Embedded location & sample recipe management
  • Dual hot-swappable batteries for continuous operation
  • Software & test wizards for easy error-free configuration
  • Open communications architecture for seamless facility integration & data management

Documentation and Application Notes

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MET ONE 3400 Features


  • ISO 14644-1 enabled sampling and reporting
  • ISO 21501-4 unit-to-unit accuracy & reproducibility
  • Enables 21 CFR Part 11 and EU Annex 1 compliance

Data Management

  • Industry standard connectivity to data management software
  • Wireless, Ethernet, serial, and USB communication
  • Printed or paperless data output


  • Easy area, group, and location based configuration of operating parameters
  • Password protected multi-level access for 21-CFR Part 11-compliant data security


  • Cleanroom routine environmental monitoring
  • Aseptic pharmaceutical production
  • Continuous environmental monitoring
  • Cleanroom classification and validation
  • Process troubleshooting
  • HEPA filter leak detection

MET ONE 3400 Specifications

Performance ISO 21501-4 unit-to-unit accuracy & reproducibility
Industry Standards ISO 21501-4 , 21 CFR Part 11, ISO 14644-1:2015, FCC, CE
Light Source Long Life Laser™ Diode
Coincidence Loss 10% at 10,000,000 particles/m³
Sample Volume 10 µm
Throughput 100 mL per minute
Reporting EU GMP, ISO 146441-1.2015, FS209E, BS5295, ISO 14644-1:1999
Zero Count ISO 21501-4 & JIS B 9921 (1 count or less in 5 min; 95% UCL)
Count Alarms Display and Cycles Raw counts: N/CF, N/CM, N/L in cumulative or differential mode, User-defined alarm counts
Item Specifications Referenced 2088900-32

Content and Resources

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Certified Calibration Services for MET ONE Calibration services flyer about audit-quality calibrations for your MET ONE air particle counter
Facility Monitoring System (FMS) Solutions Product Brochure Brochure: With new innovative designs specifically tailored to address the requirements of the Pharmaceutical industry, MET ONE particle counters feature full ISO 21501 compliance in advance of ISO 14644 standard adoption for all calibration parameters
MET ONE 3400 Series Portable Airborne Particle Counter Product brochure for the enhanced MET ONE 3400 Series, which is the easiest-to-use and easiest-to-integrate portable particle counter for any facility or environmental monitoring program
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring Whitepaper by author Tony Harrison, a Compliance and Applications Specialist for Beckman Coulter Life Sciences | Published 2017
Quality Control Testing Instrumentation Solutions for GMP Manufacturing Brochure Brochure on instruments designed for Raw Materials QC, Production QC, and Final Product QC

Technical Documents