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+:
- White Paper: GMP Cleanrooms Classification and Routine Environmental Monitoring
- White Paper: MET ONE 3400+ IT Implementation Guide
- Interview: Automating Routine Environmental Monitoring for GMP Cleanroom Compliance
- Video Series: Understanding the MET ONE 3400+
- Brochure: MET ONE 3400+ Air Particle Counter
- Application Note: MET ONE 3400+ LDAP & Active Directory Connection Guide
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.
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.
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|