Implementing Emerson’s Automation Technologies & Solutions DeltaV as a validated Process Control System (PCS) in GMP manufacturing and extending its functionality to include a non-validated Building Management System (BMS) in Life Science facilities, presents a strategic approach to optimizing operations and enhancing facility management.
1. Validated Process Control System (PCS) in GMP Manufacturing:
Regulatory Compliance: Emerson DeltaV is well-suited for GMP manufacturing environments due to its robust features and validation capabilities. DeltaV ensures compliance with regulatory requirements such as FDA’s Current Good Manufacturing Practice (cGMP) regulations by providing documentation, audit trails, and validation documentation packages.
Process Optimization: DeltaV’s advanced control algorithms and real-time monitoring capabilities optimize manufacturing processes, ensuring product quality, consistency, and efficiency. The validated nature of DeltaV instills confidence in the reliability and accuracy of process control, critical for GMP compliance.
2. Extending to Non-Validated Building Management System (BMS) in Life Science Facilities:
Operational Efficiency: Extending DeltaV to serve as a non-validated BMS in Life Science facilities enhances operational efficiency by providing centralized monitoring and control of building systems such as HVAC, lighting, and access control. While the BMS functionality may not require formal validation, it still benefits from DeltaV’s robustness and reliability.
Environmental Control: DeltaV’s advanced control algorithms ensure precise regulation of environmental conditions essential for Life Science facilities, such as temperature, humidity, and pressure. This capability supports the maintenance of optimal conditions in cleanrooms, laboratories, and storage areas, contributing to product quality and regulatory compliance.
Scalability and Flexibility: DeltaV’s scalable architecture and flexibility allow for seamless integration of PCS and BMS functionalities. Facilities can tailor the system to their specific needs, adapting to changes in operational requirements or facility expansions.
3. Synergistic Integration and Benefits:
Unified Platform: Integrating PCS and BMS functionalities on the DeltaV platform provides a unified solution for managing both manufacturing processes and facility operations. This integration streamlines operations, reduces complexity, and enhances overall efficiency.
Cost Savings: Leveraging the existing DeltaV infrastructure for both PCS and BMS functionalities eliminates the need for separate control systems, reducing capital and maintenance costs. Additionally, shared resources and expertise lead to cost savings in training and support.
Risk Mitigation: While the BMS functionality may not require formal validation, leveraging DeltaV’s proven reliability and compliance features mitigates risks associated with building system failures or deviations. This ensures continuity of operations and minimizes potential impacts on manufacturing processes.
In conclusion, extending Emerson DeltaV from a validated Process Control System in GMP manufacturing to also include a non-validated Building Management System in Life Science facilities offers synergistic benefits that enhance operational efficiency, regulatory compliance, and risk management. By integrating PCS and BMS functionalities on a unified platform, facilities can optimize processes, maintain optimal environmental conditions, and ensure operational continuity, ultimately supporting the mission-critical operations of Life Science facilities.
