Facility Monitoring System (FMS)

The Facility Monitoring Systems (FMS) for remote system monitoring can be configured to meet a wide spectrum of cleanroom management needs for various industries—including pharmaceutical production. The FMS can monitor non-viable air particle counts, air temperature, and relative humidity. Our 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
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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

Explore Facility Monitoring System Models

Content and Resources

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Modern Trends in Non‐Viable Particle Monitoring during Aseptic Processing This paper describes changes and improvements to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which is a regulatory requirement during aseptic processing. Aseptic processing is becoming more automated and increasingly important to future products of the biopharmaceutical industry. In the same manner, NVP monitoring is also becoming more automated and increasingly important for contamination risk management during aseptic processing.
Changes to GMP Force Cleanroom Re-Classifications This paper explains the rules of ISO 14644-1:2015, which has substantial revisions impacting both the way the cleanrooms are classified and the performance requirements of the air particle counting instruments used to carry out the classification.
Achieving Compliant Batch Release – Sterile Parenteral Quality Control This paper describes common QC instrumentation compliance elements and gives examples of best practice for instruments used for compliant QC batch release.
Specifying Non-Viable Particle Monitoring for Aseptic Processing This paper details key considerations when implementing a continuous non-viable particle monitoring (NVP) system.
Optimizing Workflow Efficiency of Cleanroom Routine Environmental Monitoring This paper examines a thoughtfully designed and well-executed environmental monitoring program that tests the controls put in place to maintain the cleanroom to the required Good Manufacturing Practices standards (e.g., CGMP, EU-GMP, and PIC/S).

Technical Documents

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