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Insulin Manufacturing Facility

Challenge

To meet the escalating demand for insulin, the client needed to initiate a fast-tracked project to build a new, leading-edge insulin manufacturing complex.

Approach

Approach

From preliminary engineering through plant commissioning and startup phase, our team provided project management and technical expertise for automation and validation, and project execution strategies.

To expedite construction three primary modular construction contractors were utilized for two of the process buildings. The system contains three separate DeltaV™ control systems; one for the utilities and administration area, and one for each of the two process areas.

We conducted software development and testing activities from three locations to accommodate the compressed delivery schedule. Detailed procedures, and an innovative reporting structure and meeting format allowed the team to maintain software consistency across the three development sites.

Technical and management consulting for software development logistics and procedures, testing strategy and validation strategy
Automation engineering design and development of DeltaV control systems for 14,000 I/O points. Systems included: Utilities System, Fermentation Process, Isolation Process, Purification Process, CIP System, Administration and Lab facilities
System-wide configuration software design, development, testing and implementation
Technical consulting for hardware design including bus design (FOUNDATION fieldbus, DeviceNet), panel review, power and grounding design
Software systems validation, including design specifications, source code review, testing strategy, test cases and qualifications
Onsite startup and commissioning support at the modular builders' and equipment manufacturers’ facilities and at the production facility

Results

Process scale up has been eliminated from development to production, reducing a substantial amount of time, resources and money in drug launches. The overall savings for the client are in the millions of dollars.