OBJECTIVE

The client was building a greenfield vaccine drug substance facility and utilized our pressure relief device group to conduct/prepare all pressure relief calculations and packages for both stick-built and vendor provided relief devices. Additionally, our team conducted all post installation field walkdowns and coordination with installers for mitigations. Processes analyzed involved Solution Prep, Fermentation, Harvest, Purification, Bulk Filling and all support equipment/utilities including Autoclaves, WFI, CIP, Clean Steam, Solvent Storage/Distribution, and plant utilities.