ABSTRACT

The introduction of single-use process components such as bags, filters, mixers, sterile connectors, and final filling assemblies in modern aseptic processes eliminates the need for steaming in place (SIP) and cleaning in place (CIP) and hence reduces validation work and process preparation turnaround. Single-use technologies also produce faster setup of the process equipment, higher flexibility, and lower capital expenditures. This entry details single-use process components and steps, mixing systems, and discusses validation requirements and activities.