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.

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 with 10 year mean-time-to-failure
Coincidence Loss 10% at 36,000,000 particles/m³
Reporting EU GMP Annex 1, CGMP, ISO 146441-1.2015
Zero Count 1 count or less in 5 minutes, 95% confidence level
Counting Efficiency 50% ±20% for 0.3 μm (100% ±10% for 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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Automating Quality Control Testing for Improved 21 CFR Part 11 and ALCOA Data Integrity Infographic showing manual to automated - how our QC Suite instruments help you comply with 21CFR part 11 ALCOA
ALCOA+ Infographic Guidance on Maintaining Data Integrity Infographic
Certified Calibration Services for MET ONE Calibration services flyer about audit-quality calibrations for your MET ONE air particle counter
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring This paper examines a thoughtfully designed and well-executed environmental monitoring program that tests the controls put in place to maintain the cleanroom to the required Good Manufacturing Practices standards (e.g., CGMP, EU-GMP, and PIC/S).
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring Whitepaper by author Tony Harrison, a Compliance and Applications Specialist for Beckman Coulter Life Sciences | Published 2017

Technical Documents

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