Article: Providing Sterility Assurance Between Single-Use And Stainless Systems

By John Boehm and Brent Bushnell

As numerous biopharmaceutical manufacturers have gained firsthand experience with the benefits of incorporating single-use systems into their facilities, they are looking to expand use in both up-stream and down-stream applications. This is no surprise as increased volume and diversity of pharmaceutical products is causing manufacturers to design their facilities based on shorter production runs with multiple changeovers. Meeting these demands requires operational flexibility. Production facilities must be able to easily add new products, rapidly convert processes, and quickly make operational adjustments as needed. This is where single-use systems can deliver significant value. These systems offer many benefits including rapid implementation and cost savings.