Beckman Coulter - Met one 3400+
by Beckman Coulter

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DESCRIPTION

Air Cleaners

MET ONE air particle counters lead the industry in providing solutions to monitor air cleanliness in compliance with ISO 14644, FDA CGMP and EU GMP Annex 1. Portable, remote and handheld air particle counters are designed to easily integrate into your standard operating procedure (SOP) for cleanliness monitoring for aseptic fill, routine environmental monitoring, cleanroom and flow bench validation, and air filtration troubleshooting. Offering ISO 21501-4 compliance, MET ONE air particle counters are reliable, durable and easy to integrate into your 21 CFR Part 11 compliant workflow.

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FEATURES

  • Customized interactive electronic SOP Maps
  • Interactive tracking
  • Electronic records Straight from the counter
  • Web Browser SOP Version control and review & approve workflow

Additional 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

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