UPM Pharmaceuticals - Perfection Group
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UPM Pharmaceuticals

 

LOCATION

Bristol, TN

 

CONTRACT TYPE

System Upgrade

 

DIVISION

Service and Maintenance

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Project Overview

  • FACILITY LAYOUT
    Multiple Buildings
  • MARKET
    Healthcare
  • TOTAL SQUARE FOOTAGE
    416,178 sq ft
  • EQUIPMENT
    Honeywell N4 Supervisor software
    Honeywell Jace 8000 (7)
    E-Sign module for FDA Part 11 compliance

FEATURES

UPM Pharmaceuticals, a global leader in sustainable manufacturing, operates a critical facility requiring precise environmental control to ensure product and regulatory compliance. The facility’s legacy Building Automation System (BAS) was based on the Tridium Niagara R2 platform. The system managed critical environmental parameters such as temperature and humidity and supported operations that required adherence to FDA 21 CFR Part 11 compliance standards.

 

To meet evolving regulatory requirements, improve reliability, and modernize operations, UPM decided to upgrade to the Tridium Niagara N4 platform. The project also required the integration of advanced features like historical data storage and real-time temperature and humidity alarm notifications.

 

 

CHALLENGES

  • FDA Compliance Requirements:
    • Achieving secure, tamper-proof data logging with digital signatures and detailed audit trails.
  • Historical Data Migration
    • Migrating historical temperature and humidity data from R2 to N4 without data loss or corruption.
  • Critical Environmental Control
    • Maintaining uninterrupted control of critical temperature and humidity systems during the upgrade.
  • Integration with Legacy Hardware
    • Ensuring that older field devices could communicate with the new N4 system.

 

 

SOLUTION

  • Regulatory Compliance
    • Achieved full FDA 21 CFR Part 11 compliance with secure, auditable data storage and traceability.
  • Enhanced System Capabilities
    • Migrated to the Niagara N4 platform, improving speed, reliability, and user experience.
    • Enabled seamless communication between legacy hardware and modern IoT devices.
  • Real-Time Monitoring and Alarm Notifications
    • Implemented robust alarm notification systems for temperature and humidity thresholds, reducing response times.
    • Custom dashboards and analytics tools provided actionable insights.
  • Reliable Historical Data Storage
    • Safely migrated over 5 years of historical data to a secure database.
    • Enabled long-term trend analysis for compliance audits and operational optimization.
  • Operational Continuity
    • Executed the upgrade with less than 2 hours of total downtime, ensuring uninterrupted environmental control.