Facility Monitoring System

Beckman Coulter Life Sciences provides Facility Monitoring Systems (FMS) that can be configured to meet a wide spectrum of cleanroom management needs for various industries—including pharmaceutical production. Beckman Coulter FMS can monitor non-viable air particle counts, air temperature, and relative humidity. All of the company’s FMS solutions are based on an open-architecture platform designed to enable easy, streamlined integration with existing customer systems (SCADA). Each instrument is built around proven MET ONE technology, including the portable MET ONE 3400 series for routine monitoring and cleanroom classification, as well as the 6000 and 7000 series of fixed, non-viable air particle counters. MET ONE software platforms feature intuitive interfaces to help make them easy to use, thereby reducing the potential for human error that can occur with manual SOP monitoring. In addition, to help centralize reporting and simplify EUGMP/FDA compliance (e.g., for ISO 14644 and 21 CFR Part 11), Beckman FMS data can be integrated into a single-release, electronically signed paperless report.

  • Workflow optimized, integrated solutions to monitor your cleanroom
  • 21 CFR Part 11 enabling software workflow to ensure secure data management
  • Integrate portables and remote air particle counters

Choose a MET ONE Facility Monitoring System Model

Tech Docs Part Number Product Name Description Flow Rate Particle Size Analysis Range List Price Buy

Features

Software

  • Simple interface for air particle counting monitoring and reporting
  • Wizard-based installation and configuration of counters
  • One-touch report generation
  • Document templates for IQ/OQ
 

Service Options

  • Regional Service Professionals provide onsite ISO 21501-4 calibration and service
  • Service agreement options for pre-scheduled onsite calibration and maintenance (including discounts for repairs)

Data Management

  • Collapse multiple monitoring systems into single integrated systems for easier validation, maintenance, and data management
  • Redundant data management eliminates single points of failure

Compliance

  • ISO 14644 Cleanroom Management
  • ISO 21501-4 Air Particle Counter Calibration for Accuracy and Repeatability across sensors
  • 21 CFR Part 11 for management of electronic data records
  • EU GMP Annex 1 for manufacture of sterile medicinal products
     

Product Specifications

Performance ISO 21501-4 unit-to-unit accuracy & reproducibility
Industry Standards ISO 21501-4 , ISO 14644-1:2015, FCC, CE
Light Source Long Life Laser™ Diode
Particle Size Analysis Range 0.50|10.00|μm / 0.5|10|μm
Flow Rate 28.32 L per minute
Coincidence Loss 10% at 20,000,000 particles/m3
Sample Volume 10.00|µm
Throughput 28.32 L per minute
Zero Count ISO 21501-4 & JIS B 9921 (1 count or less in 5 min; 95% UCL)
Count Alarms Display and Cycles User-defined alarm counts displayed via LED on box or remote LED
Item Specifications Referenced 2088615-PF-EA

Documentation

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