Faced with an escalating demand for insulin, an outdated manufacturing facility and regulatory commitments to the FDA, the client implemented a project to upgrade their Insulin Fill-Finish plant to increase capacity,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.
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.
Cornerstone Controls was responsible for the following areas: