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
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