Global pharma, two new paperless production sites.

Situation:

One of the world’s largest pharmaceutical companies had a major opportunity – and a massive challenge. The firm had scored success with a new compound and needed to quickly build two new production facilities to satisfy growing global demand. At the same time, the company wanted its new plants to
fulfill its next-generation vision of automation-driven, paperless factories with complete data availability for analytics and process improvement.

Understanding the magnitude of the undertaking, the company brought Stellix, a proven partner, in to collaborate on the project

Challenge:

Both plants needed to be built and operational by 2026. To meet that opening date, the company would need a Basis of Design for the plants’ Digital Operations Management in a matter of weeks.

This challenge was compounded by the fact that the company’s vision for the facilities was both untried and technologically complex. It called for:

• Fully digital, paperless operations
• Full data integrity and availability for process analytics
• Implementation of “Lean MES”
• Implementation of additional complementary components, including Historian, eLogs, and SAP integration

The client requested a Basis of Design and an associated high-level implementation plan for Operations Management. The design was to include:

• OSIsoft’s PI Historian to capture, store, and provide secure, connected data flow from equipment to automation to electronic batch record
• An “automation-driven” approach, in which MES functions are integrated with the Distributed Control System (DCS)
• Full batch genealogy
• A Knowledge Management solution for Recipe Management to speed product turnovers and recipe revisions, including full parameterization of DeltaV, Syncade, LIMS, and SAP parameters
• Seamless, fully digital exception tracking for Review-by-Exception
• Foundational deployment for eventual production scheduling and OEE tracking

Outcome:

The Basis of Design not only satisfied the pharmaceutical company’s next-generation vision and met its requirements but also enabled the firm to begin preparing estimates for the next phase of development. Equally significant, it brought the company’s process engineers and automation leads together to confirm and support the MES layer design through wireframes developed by Stellix.

Stellix’s unique blend of expertise in legacy solutions and willingness to try new approaches was key to the project’s success. The strategies adopted for this project are not widely used, and the complex integration requirements call for skills that many systems integrators do not possess. This enabled a true collaboration that resulted in a better, more robust design.