Insulin Manufacturing Facility

Industry

Pharmaceutical

Business Issue

To meet the escalating demand for insulin, the client initiated a fast track project to build a new insulin manufacturing complex. 

Project Summary

This bulk manufacturing facility produces bulk insulin that is then sent to a Fill-Finish facility for packaging.  The process is a batch operation including fermentation, isolation, and purification processes as well as the utility operations to support both the process areas and the administration buildings.  The project team was involved in the project from the preliminary engineering phase through the plant commissioning and startup phase.  Project management and Technical expertise was provided in the preliminary engineering phase for both automation and validation strategy and for project execution strategy.

To expedite the construction of the facility, the customer elected to utilize three primary constructors of modular construction for two of the process buildings.  The utilities and administration buildings were stick built facilities.  The project included preliminary field checkout of the instrumentation at the modular builder and equipment facilities.  Cornerstone also supported the equipment FAT testing at the equipment manufacturers.

The system consists of three separate DeltaV systems; one for the utilities and administration area and one for each of the two process areas.  The system utilizes Field Bus and DeviceNet technology and interfaces to PLC controlled equipment such as centrifuges and autoclaves.  The system also interfaces to the plant Data Historian.

Due to the compressed delivery schedule, the project team conducted software development and testing activities from three locations.  Detailed procedures, and an innovative reporting structure and meeting format allowed the team to maintain software consistency across the three development sites.  Close relationships between the customer technical leads and the development leads ensured that the software met the needs of the customer.

Scope Responsibility

Cornerstone Controls was responsible for the following areas:

  • Overall DeltaV automation project management including one program manager and 4 area project managers. Project manpower totaled 50+ man-years labor.  Four locations were used for software development and testing.
  • Technical and management consultant for software development logistics and procedures, testing strategy, and validation strategy.
  • Automation engineering design and development of DeltaV systems for 14000 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 consultant for hardware design including bus design (Field Bus, DeviceNet), panel review, power and grounding design.
  • Software validation of systems including, Design Specifications, Source Code Review, Testing Strategy, Test Cases and Qualifications.
  • On site Startup and Commissioning Support at the modular builders and equipment manufacturers’ facilities and at the production facility.

Results

The facility is in production waiting for final product approval.