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Beckman Coulter MET ONE 3445+ GMP Cleanroom Routine Environmental Air Particle Counter

Item#: C38687

The MET ONE 3445+ 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.

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Supplier:
  • 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: 0.5 - 10 μm
  • Flow Rate: 100 L per minute
  • Coincidence Loss: 10% at 10,000,000 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, 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 0.5 µm (100% for particles > 0.75 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)
  • Dimensions (WxDxH): 10.5”x 8.3” x 10.2 (26.7x 21x 26cm)
  • Color: Silver
  • Package Quantity: 1

Customized Interactive Electronic SOP Maps

Using a web-browser interface, load your SOP map into the counter, mark sample locations, and define SOP sampling requirements for each.

Interactive Tracking

Onscreen instructions help operators navigate your map and perform sampling according to the SOP. Location names turn green after sampling, making it easy to track progress at a glance.

Electronic Records Straight from the Counter

The MET ONE 3400+ can provide electronic records straight from the counter via USB, wired Ethernet or built-in WiFi.

Web-browser SOP Version Control and Review & Approve Workflow

Managers can remotely review daily monitoring progress including all sample results via a web-browser. Remote SOP configuration and version control is also available for administrators, as well as remote review & approve, electronic signature sign-off and electronic record export for supervisors – all via web-browser.

 

  • 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

Beckman Coulter MET ONE 3400+ Particle Counters Brochure

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MET ONE 3400+ Revised Cleanroom Standards ISO 14644-1 and -2


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