Facility Monitoring System

We provide scalable Facility Monitoring Systems (FMS) that can be configured to meet a wide spectrum of cleanroom management needs for various industries—including pharmaceutical production. Among parameters that can be efficiently and reliably monitored using a Beckman Coulter FMS are non-viable/viable air sampling, differential pressure, 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. To avoid losses from product contamination, stack lights, audible alarms and process shutdown signals from a Beckman Coulter FMS can prompt an immediate production line response whenever an excursion happens. 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
  • Industry standard interfaces (OPC, ODBC) for integration with other systems
  • Support for 32 location manifold integration for automated routine environmental monitoring

Features of the MET ONE Facility Monitoring System

Particle Monitoring Compliance

  • Nonviable and viable particle monitoring compliant with EU GMP
  • Annex 1 and FDA 21 CFR Part 11
  • Built in Audit Logging
  • Custom reports to record results
  • IQ/OQ documentation for simple validation

Scalable Solutions

  • Small scale, rapidly deployed pre-packaged software and hardware for isolators and small production line
  • Batch workflow system for one or more production lines with several monitoring points
  • Custom workflow optimized solutions for monitoring complex production methods across several production lines

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)

Ease of Use

  • Graphical user interfaces available on the system or via remote access terminals
  • Color coded indication of system status
  • Alarms clearly identified for acknowledgement
  • Single click reports to generate auditable records for compliance

Components of the Facility Monitoring System

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
Coincidence Loss 10% at 20,000,000 particles/m³
Sample Volume 10 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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Technical Documents