Insulin Manufacturing Facility Upgrade

Industry

Pharmaceutical

Business Issue

Faced with an escalating demand for insulin, an outdated manufacturing facility and regulatory commitments to the FDA, the client implemented a project to upgrade their Insulin Fill-Finish plant to increase capacity, provide integrated automation systems and meet stringent FDA requirements.

Project Summary

This Fill-Finish facility produces injectable drugs and consists of OEM skid mounted equipment, stick built processes and utilities.  This equipment includes equipment prep, media prep and formulation, filling and freeze-drying, clean and plant utilities.

To meet the capacity goals and the compliance requirements, 50% of the equipment and the attendant automation systems were to be upgraded or replaced.  A project timeline of 15 months was committed to the FDA.  Production constraints meant that the plant could only be shutdown for 22 weeks to allow all the upgrade work to be completed. 

Because insulin is a life-saving medicine and millions of people depend upon it, once the plant was shut down, it was absolutely essential that production be restored at the scheduled time.

Scope Responsibility

Cornerstone Controls was responsible for the following areas:

  • Project management of up to 60 professionals to meet aggressive schedule and control cost.
  • Automation engineering design and development of Rockwell ControlLogix PLC and RSView SE HMI systems for 7000 I/O points.
  • Design and Development of Aspen Tech Data Historian.
  • Systems included:
    • Getinge Autoclaves
    • Steris Compartment Washers
    • Bosch Vial Filling Equipment
    • Formulation/Media Prep
    • CIP/SIP
    • Mueller Clean Steam
    • WFI
  • Software validation included:
    • Validation plans
    • Test plans
    • Test Case Qualifications
  • Technical Consulting on Instrumentation Design and Qualification
  • Management and support for Instrumentation calibrations
  • Design and installation management of HMI consoles
  • Startup and Commissioning

Results

  • Project came in on schedule and 3% under budget.
  • Software development and testing was delivered prior to site startup date.
  • Plant has passed post project FDA inspections.
  • Plant has used integrated automation systems and data acquisition tools to improve product yields.