The MET ONE 3400 Series is the easiest and most reliable calibration device 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

MET ONE 3400 Features

Standards

  • 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

Operation

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

Applications

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

MET ONE 3400 Specifications

PerformanceISO 21501-4 unit-to-unit accuracy & reproducibility
Industry StandardsISO 21501-4 , 21 CFR Part 11, CE, FCC, ISO 14644-1:2015
Coincidence Loss5% at 14,126,000 particles/m³
Throughput28.32 L per minute
Zero CountISO 21501-4 & JIS B 9921 (1 count or less in 5 min; 95% UCL)
Count Alarms Display and CyclesUser-defined alarm counts, Raw counts: N/CF, N/CM, N/L in cumulative or differential mode
Item Specifications Referenced2088900-03-W