Challenge
A confidential pharmaceutical manufacturer faced an urgent need to modernize its aging Active Pharmaceutical Ingredient (API) production facility. Tightening regulatory requirements and rising production demand exposed the limitations of the legacy manual system, which could not ensure high product quality, throughput, or electronic data integrity. To address these needs, the company decided to completely overhaul one manufacturing wing, replacing decades-old manual equipment with modern process systems and a centralized digital control infrastructure. Compliance with FDA Good Manufacturing Practice (GMP) and 21 CFR Part 11,particularly regarding electronic records and data integrity, was a top priority.
The project presented several intertwined challenges:
- Complex System Integration: The upgrade introduced numerous new process components; reactors, vacuum pumps, clean utility skids, temperature control units, and more sourced from various vendors. Achieving a seamless, unified Distributed Control System (DCS) was essential to integrate these disparate elements. The integration included many OEM skid controls, ISA-88 style batching system, and hundreds of instruments and I/O into a single PlantPAx™ platform to ensure coordinated operation.
- Evolving Requirements & Regulatory Compliance: At the outset, the control system scope was not fully defined; a formal User Requirements Specification (URS) was not established. Hallam-ICS needed to remain agile, adapting control system design to newly specified batch sequences, process parameters, and documentation needs. All documents and system architecture had to comply strictly with U.S. GMP standards and 21 CFR Part 11, demanding rigorous validation protocols and comprehensive records (URS, FS, SDS, IQ/OQ, etc.).
- Schedule & Logistics Constraints: The client committed to a rapid startup to deliver a critical pharmaceutical ingredient on time. Supply chain disruptions (2021–2022) threatened the timeline, with long lead times for hardware such as Rockwell Automation controllers and network components. The project required precise scheduling and coordination to ensure timely procurement and delivery of all instruments, control panels, and materials. In addition, Hallam-ICS had to synchronize commissioning activities with a third-party validation team and train plant personnel transitioning from manual to automated processes.
Solution
Hallam-ICS delivered a comprehensive, turnkey process control solution, managing the project from engineering design through programming, panel fabrication, installation, and startup. Their multidisciplinary team brought expertise in process controls, instrumentation, electrical installation, and validation support, ensuring system elements worked cohesively.
The backbone of the upgraded control system was Rockwell Automation’s PlantPAx DCS (version 5.x), selected for its suitability for batch pharmaceutical processes, robust electronic recordkeeping, and compliance features. Key aspects of the solution included:
- Unified Automation Platform: PlantPAx DCS served to integrate new and existing process equipment, OEM skids, and building management systems, providing centralized control and monitoring.
- Agile Design Approach: Hallam-ICS worked closely with the client to adapt the control system as requirements evolved, developing documentation and system architecture to meet updated GMP and 21 CFR Part 11 standards.
- GAMP Documentation and Validation: Comprehensive project records and validation protocols were established, including URS, Functional Specifications (FS), Software Design Specification (SDS), and Installation/Operational Qualification (IQ/OQ), supporting regulatory compliance and audit readiness.
- Logistics Coordination: Hallam-ICS managed procurement and delivery of all hardware, coordinated installation /calibration, and aligned commissioning with third-party validation teams. They also trained plant staff on the new automated processes, ensuring a smooth transition from manual operations.
