MET ONE 3413+ GMP Cleanroom Routine Environmental Air Particle Counter
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
|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|
|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|
|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|
NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES
PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS
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."
CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). (Note: Devices may be CE marked to other directives than (98/79/EC)
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.