ABSTRACT
Historically, companies that produce high-purity biotechnology or pharmaceutical products face a host of complex challenges when planning and executing new or retrofitted facility projects. They must manage multiple relationships with separate suppliers who are contracted independently of one another, often leading to confusion regarding responsibilities. These responsibilities include the areas of engineering/design, procurement, construction, startup and validation, frequently resulting in cost overruns, change orders, rework and general duplication of efforts across supplier and contractors.
Most importantly, this traditional approach to the design and construction of process systems creates scheduling problems that delay product time to market, potentially representing millions in lost or delayed revenues for Owners.
