MET ONE 3400 Portable Air Particle Counter

No Longer Available for Purchase

The MET ONE 3400 is no longer available for purchase.

Beckman Coulter Life Sciences will continue to offer routine service and calibration for the legacy family of MET ONE 3400 and 3411 products for a period of five (5) years after July 1, 2021. However, breakdown repairs cannot be guaranteed if the required repair component is made obsolete by our supplier.

Available now
MET ONE 3400+ GMP Cleanroom Routine Environmental Air Particle Counter

The MET ONE 3400+ family has the following advantages over the legacy MET ONE 3400 models:

  • Stronger 21 CFR Part 11 Data Integrity features
    • Your routine environmental SOP as an interactive map on the counter screen
    • Secure electronic records straight from the counter via Wi-Fi and wired Ethernet as standard on all models
    • Microsoft Active Directory for User Name and Password control
  • More ergonomic design
    • Remote access via Web-browser via Wi-Fi and wired Ethernet
    • Smaller footprint at just 26.7cm W x 26cm H x 21cm D (10.5” x 10.25” x 8.25”)
    • Lighter to carry at just 5.6Kg/12.4lb

Interested in the MET ONE 3400+ air particle counter?

Click to learn more.

Resources + Tools
21 CFR Part 11 FAQs Features Request Quote Standards Tech Docs

Explore MET ONE 3400 Series Models

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

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.
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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