Skid Automation Project for Injectable Therapeutic
CASE STUDY
Integration of Advanced Filtration Units with a Modern DCS
OBJECTIVE: The project focused on integrating two filtration skids, one ultrafiltration (UF) and one diafiltration (DF), for pre-viral and post-viral purification into the existing DeltaV distributed control system (DCS).
CHALLENGE: Each filtration skid was made by a different vendor and used different technologies, one using Clean In Place (CIP) technology and the other using single-use liners. This made coordination and communication challenging since Hargrove needed to work closely with the company and directly with the skid vendors to ensure consistency while meeting timelines.
Another complexity involved aligning new equipment module classes with the company’s existing templates, which required careful documentation and testing. Hargrove needed to adhere strictly to PCSD standards and use deferred parameters to maximize reuse, ensuring consistency and maintainability.
Solution
Comprehensive Lifecycle Automation Services
The project scope encompassed full lifecycle automation services, including:
- Software design, documentation, and development
- Peer review and development testing
- Hardware FAT testing at the filtration skid vendors’ facilities
- Software Factory Acceptance Test (SFAT) and Site Acceptance Test (SAT) execution
- Integration of control modules, equipment modules, and recipes using the company’s PCSD-based library
- PI tag configuration and coordination
- Graphics development and testing using MiMiC process simulation software
- On-site support for commissioning, validation, and loop checks
The project also required constructing a portable DeltaV control controller test system for FAT execution at vendor sites in California and Wisconsin. Both skids used a combination of bus technologies that simplified the connection to the DeltaV controllers. While all logic control was done via the main DeltaV controllers, the skids provided all necessary electrical and instrumentation components, including VFDs.
Additionally, the Hargrove Team updated the company’s DeltaV system architecture drawings and coordinated closely with their PI resources to ensure seamless data integration.
To streamline onboarding and reduce costs, the same personnel were assigned for loop checks and SAT support across both skids, ensuring continuity and efficiency.
Results
Impact on Purification Operations
The project was executed on a lump sum basis, providing budget assurance for the biopharmaceutical company. Milestones were met as planned, with SFAT, FAT, and SAT phases completed between December and May. The automation enhancements improved process control, data integrity, and operational reliability for the company’s purification suites. Through rigorous planning, technical excellence, and collaborative execution, the project enhanced the company’s purification capabilities and helped deliver innovative, life-saving treatments to patients around the world.
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