Published: November 2018
Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly reducing the risk of contamination in manufacturing equipment. The implementation of single-use technology into a process requires a well-defined plan that minimizes surprises during the later stages of implementation. This can be a challenge when dealing with a revolutionary technology that is flexible, continues to evolve, and can be customized to the end-user’s requirements. To take advantage of the flexibility of single-use technology, it is important to understand how the single-use products can work together with manufacturing operations. This Guide intends to provide a roadmap for efficient implementation of single-use technology with minimum disruptions to existing operations.
The application of this Guide starts after a decision to implement single-use technology is made; that is, all financial assessments have been completed and the results of those assessments support the use of single-use technology in a process. This Guide is aimed at helping the single-use product end-users and suppliers with selection, design, and implementation after this decision has been made. This Guide is intended for those new to single-use technology while still benefiting those experienced with it.
The growth of single-use technology (SUT) has revolutionized the bioprocess industry. The implementation of single-use technology (SUT) has typically been a trial and error exercise for the end users.