MET ONE 3400+ Series GMP Cleanroom Routine Environmental Air Particle Counter

Our new MET ONE 3400+ Series Portable Airborne Particle Counter allows users to load their routine environmental monitoring SOP sampling map and sampling configuration for each location directly into the counter, so that the SOP becomes an interactive sampling map directly on the counter screen to guide users doing daily sampling. This helps reduce training requirements and sampling data errors/omissions.

Accessed remotely via a web browser, features such as review/approve workflow, SOP version control and electronic record export are all in the counter – there’s no external software needed. Secure on-board searchable/filterable Audit Trail provides fast reporting during audits combined with Microsoft Active Directory for User Name and Password control for log-on and electronic signatures to support 21 CFR Part 11 compliance.

Learn more about the MET ONE 3400+:

MET ONE 3400+ Features

Customized Interactive Electronic SOP Maps

Using a web-browser interface, load your SOP map into the counter, mark sample locations, and define SOP sampling requirements for each.

Interactive Tracking

Onscreen instructions help operators navigate your map and perform sampling according to the SOP. Location names turn green after sampling, making it easy to track progress at a glance.

Electronic Records Straight from the Counter

The MET ONE 3400+ can provide electronic records straight from the counter via USB, wired Ethernet or built-in WiFi.

Web-browser SOP Version Control and Review & Approve Workflow

Managers can remotely review daily monitoring progress including all sample results via a web-browser. Remote SOP configuration and version control is also available for administrators, as well as remote review & approve, electronic signature sign-off and electronic record export for supervisors – all via web-browser.

Explore MET ONE 3400 Plus Models

MET ONE 3400+ Specifications

Industry Standards ISO 21501-4 , 21 CFR Part 11, ISO 14644-1, EU GMP (2015), CE, FCC, 802.11, 802.1x
Light Source Long Life Laser™ Diode
Coincidence Loss 10% at 36,000,000 particles/m³
Reporting EU GMP Annex 1, CGMP, ISO 146441-1.2015
Zero Count ISO 21501-4 & JIS B 9921 (1 count or less in 5 min; 95% UCL)
Counting Efficiency 50% at 0.3 µm (100% for particles > 0.45 µm)
Count Alarms Display and Cycles Multiple user-defined alert and/or alarm levels for counts, concentration, or environmental sensors
Item Specifications Referenced C38675

Content and Resources

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Quality Control Testing Instrumentation Solutions for GMP Manufacturing Brochure Brochure on instruments designed for Raw Materials QC, Production QC, and Final Product QC
Facility Monitoring System (FMS) Solutions Product Brochure Brochure: With new innovative designs specifically tailored to address the requirements of the Pharmaceutical industry, MET ONE particle counters feature full ISO 21501 compliance in advance of ISO 14644 standard adoption for all calibration parameters
MET ONE 3400 Series Portable Airborne Particle Counter Product brochure for the enhanced MET ONE 3400 Series, which is the easiest-to-use and easiest-to-integrate portable particle counter for any facility or environmental monitoring program
Manufacturing Processes for Engineered T-Cell Therapy – CAR-T Brochure presenting the CAR-T cell therapy workflow and associated product portfolio
Certified Calibration Services for MET ONE Calibration services flyer about audit-quality calibrations for your MET ONE air particle counter

Technical Documents

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