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

Documentation and Application Notes

 

 

Choose a MET ONE Facility Monitoring System Model

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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 managements
  • 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

Particle Size Analysis Range 0.50 - 10.00 μm / 0.5
Zero Count ISO 21501-4 & JIS B 9921 (1 count or less in 5 min; 95% UCL)
Item Specifications Referenced 2088615-PF-EA

Documentation

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