MET ONE 3400+ Series Portable Airborne Particle Counter

Smart Environmental Monitoring for GMP Cleanrooms

The MET ONE 3400+ Series sets a new standard for pharmaceutical cleanroom classification and environmental monitoring. Designed for simplicity, compliance, and efficiency, it transforms complex SOPs into interactive, on-screen workflows—directly on the device. No paper checklists, no separate software, just smarter sampling while supporting ISO 14644 and EU GMP Annex 1 requirements.

Key Features

  • Interactive SOP Sampling Maps Upload your routine environmental monitoring SOPs and maps directly into the counter. Users follow step-by-step guidance on the screen, reducing training time and user error.
  • Web-Based Remote Access Access the instrument via a standard web browser—no additional software needed. Perform review and approval workflows, manage SOP versions, and export electronic records seamlessly.
  • Built-In Audit Trail & Compliance Tools Signatures and access controls help enable 21 CFR Part 11 compliance. Uses Microsoft Active Directory for centralized user authentication and authorization.
  • Seamless IT Integration Easy configuration with Microsoft Active Directory. No IT headaches—fast deployment and secure operation within your existing infrastructure.

Benefits

  • Reduce Training Time Interactive maps simplify onboarding and daily operation, even for new users.
  • Minimize Sampling Errors Guided workflows help ensure consistency and data integrity across all locations.
  • Streamline Compliance Supporting 21 CFR Part 11 compliance with secure login, audit trails, and e-signatures—all built in.
  • Accelerate Audits and Reporting Quickly locate and filter records during inspections with electronic records.
  • No Additional Software Required Everything you need is in the instrument—lower overhead and faster installation and validation.


Explore the Full Potential of the MET ONE 3400+ Series:

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MET ONE 3400 Air Particle Counter

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Content and Resources

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Conducting the ISO 14644-3 Cleanroom Recovery Test with the MET ONE 3400+ This application note reviews the test method and provides guidance on selecting both the “Challenge” and the “Target Cleanliness Limit”. Attention is given to the requirement that the test concentration should not be so high that “residue contamination” becomes a risk.
GMP Cleanrooms Classification and Routine Environmental Monitoring The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation.
Modern Trends in Non‐Viable Particle Monitoring during Aseptic Processing This paper describes changes and improvements to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which is a regulatory requirement during aseptic processing. Aseptic processing is becoming more automated and increasingly important to future products of the biopharmaceutical industry. In the same manner, NVP monitoring is also becoming more automated and increasingly important for contamination risk management during aseptic processing.
Changes to GMP Force Cleanroom Re-Classifications This paper explains the rules of ISO 14644-1:2015, which has substantial revisions impacting both the way the cleanrooms are classified and the performance requirements of the air particle counting instruments used to carry out the classification.
Achieving Compliant Batch Release – Sterile Parenteral Quality Control This paper describes common QC instrumentation compliance elements and gives examples of best practice for instruments used for compliant QC batch release.

Technical Documents

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