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.


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Content and Resources

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Resource Type
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.
Cleanroom Routine Environmental Monitoring – FDA Guidance on 21 CFR Part 11 Data Integrity This paper examines the risk of error with SOPs being implemented manually. Technology exists and is commercial available to mitigate this problem and make programs more robust, reducing the impact on data integrity and also supporting the industry's move towards environmental monitoring by production staff in the cleanroom.

Technical Documents

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