• 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 Air Particle Counter
Item#: METONE3400The Beckman Coulter 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.
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+ Revised Cleanroom Standards ISO 14644-1 and -2
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