8 Strategies To Ensure Successful Retrofit Of Pharmaceutical Manufacturing Automation Systems

By Richard Parapar

This paper presents a range of proven best practices and project strategies for performing major system retrofits in GMP manufacturing facilities, using the successful case study at the Genentech CCP1 Facility in Vacaville, CA as an example.

As pharmaceutical manufacturing automation systems age, mission-critical computing hardware and software components eventually fail or become obsolete for a variety of reasons. Inevitably, these systems need to be upgraded or replaced. Major system retrofits face particular challenges, risks, and constraints, and system owners must find innovative ways to limit potentially significant costs resulting from extended plant downtime. If not well planned, these projects can have an adverse impact to manufacturing operations and, in extreme cases, continued viability of the business entity. This paper presents a range of proven best practices and project strategies for performing major system retrofits in GMP manufacturing facilities, using the successful case study at the Genentech CCP1 Facility in Vacaville, CA as an example. The initial phase of the CCP1 DCS retrofit project concluded successfully in August 2013 with all business and technical objectives achieved. The facility returned to GMP operation after only 10 days of downtime, which was factored into a planned shutdown for periodic utilities maintenance.