MET ONE 3413+ GMP Cleanroom Routine Environmental Air Particle Counter

MET ONE 3413+ GMP Cleanroom Routine Environmental Air Particle Counter

The MET ONE 3400 Series is the easiest and most reliable portable air particle counting solution for a wide variety of cleanroom applications—from aseptic production and process troubleshooting to continuous monitoring, classification and validation. Complete your cleanroom work quickly, confidently, and securely in compliance with ISO 14644, 21 CFR Part 11, and EU GMP Annex 1 requirements.

Description

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

Met One 3400+ Product Launch Video

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            EU GMP Annex 1, CGMP, 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