MET ONE 3413+ GMP Cleanroom Routine Environmental Air Particle Counter

C38675


The MET ONE 3413+ portable air particle counter helps GMP cleanroom users simplify their routine environmental monitoring and improve data integrity. Lighter and quieter than previous models, the new instrument enables users to import their Standard Operating Procedure (SOP) routine environmental monitoring maps and sampling configurations into the counter itself.

  • SOP configuration, sampling maps and SOP version control are loaded into the counter itself via a web-browser
  • Administrator manages SOP versions in the counter using electronic signatures
  • The sampling map, loaded into the counter as part of the SOP, guides the user around their daily monitoring program
  • As each sample is completed, it turns green on the screen, showing the user what remains to be done at a glance
  • Once completed, the results can be reviewed and approved remotely by the Supervisor using a web browser
  • Once approved, an electronic signature is attached to the final report which can then be exported in secure electronic format

Specifications

Platform APC Instruments
Performance ISO 21501-4 unit-to-unit accuracy & reproducibility
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
Particle Size Analysis Range 0.3 - 10 μm
Flow Rate 28.32 L per minute
Coincidence Loss 10% at 36,000,000 particles/m³
Throughput 1 cubic meter in 35.3 minutes
Interfaces & Protocols 802.11 b/g Wireless, 802.3 Ethernet, USB 2.0 Host, HTTP, Windows File Sharing
Data Storage 1 million samples
Reporting ISO 146441-1.2015
Battery Lithium ion smart battery (rechargeable, ejectable & hot-swappable)
Battery Operating Time 5.7 hours (typical usage)
Battery Recharge Time 3.5 hours (minimum) - 6.75 hours (maximum)
Pump Type Air vacuum, rated for continuous use
Pump Accuracy ±5% Flow Rate
Pump Repeatability ±5% Flow Rate
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 & Cycles Multiple user-defined alert and/or alarm levels for counts, concentration, or environmental sensors
Label Locations Unlimited UTF-8 International Character Set
Environmental Conditions Indoor Environment
Temperature Range Operating temperature range: 0°C to 40°C, Storage temperature range: -20°C to 50°C
Humidity Restrictions 10%-90% relative humidity (non-condensing)
Power Requirements 80-264 VAC, 47-63 Hz, 1.2 A Max. Power Supply
Operating System Beckman Custom Linux OS
Software Clarity Wireless Fleet Data Management
Resolution 1024 x 768
Display 10" High Resolution Capacitive Touchscreen LCD
Operating Modes SOP Automated or Manual, selected by operator
Autoclavable No
Nonpyrogenic Yes
Weight 5.6 kg (without battery)
Width 26.7 cm / 10.5 in
Depth 21 cm / 8.3 in
Height 26 cm / 10.2 in
Color Silver
Package Quantity 1

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The listed regulatory status for products correspond to one of the below:
IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use."
ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagents. Analytical and performance characteristics are not established."
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RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures."
LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only."
No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.