Meeting cGMP Standards by Taking Commissioning to the Next Level
Genentech Fill and Finish Facility
Hoffman’s in-house commissioning specialists play a key role to deliver a sophisticated pharmaceutical manufacturing facility.
The Genentech ‘Fill and Finish’ plant is a specialized 310,000 SF facility that takes in biopharmaceutical products and turns them into vials and syringes ready for distribution to healthcare providers. It is Genentech’s only fill and finish facility, as well as the pharmaceutical giant’s West Coast distribution center. Hoffman built it in an intensely collaborative design-build process, working very closely with the owner – who kept a large team on-site – and the electrical and mechanical partners. We held regular coordination meetings with the entire team in the field and used BIM extensively to resolve potential clashes. The entire facility is built to cGMP—Current Good Manufacturing Practices—to achieve FDA certification. Hoffman handled the detailed commissioning process in-house, documenting thousands of welds and miles of complex process piping. Hoffman also built 1,500 SF data room as part of a larger complex using roof mounted dedicated air handlers and a hot/cold isle configuration.