MET ONE 3415+ GMP Cleanroom Routine Environmental Air Particle Counter

MET ONE 3415+ GMP Cleanroom Routine Environmental Air Particle Counter

Product no. C38678

PlatformAPC Instruments
Industry StandardsISO 21501-4 21 CFR Part 11 ISO 14644-1 EU GMP (2015) CE FCC 802.11 802.1x
Light SourceLong Life Laser™ Diode
Particle Size Analysis Range0.5 to 10 μm
Flow Rate28.32 L per minute
Coincidence Loss10% at 36,000,000 particles/m³
Data Storage1 million samples
ReportingEU GMP, ISO 146441-1.2015
BatteryLithium ion smart battery (rechargeable, ejectable & hot-swappable)
Battery Operating Time5.7 hours (typical usage)
Battery Recharge Time3.5 hours (minimum) - 6.75 hours (maximum)
Pump TypeAir vacuum, rated for continuous use
Pump Accuracy±5% Flow Rate
Pump Repeatability±5% Flow Rate
Zero CountISO 21501-4 & JIS B 9921 (1 count or less in 5 min, 95% UCL)
Counting Efficiency50% at 0.5 µm (100% for particles > 0.75 µm)
Count Alarms, Display & CyclesMultiple user-defined alert and/or alarm levels for counts, concentration, or environmental sensors
Label LocationsUnlimited UTF-8 International Character Set
Weight5.6 kg (without battery)
MET ONE 3415+ GMP Cleanroom Routine Environmental Air Particle Counter
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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 Reagent. Analytical and performance characteristics are not established." CE-IVD, CE: Products intended for in vitro diagnostic use and conforming to the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. (Note: Devices may be CE marked to other directives.) 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.