Single-Use Manufacturing Systems: Implementation Considerations

Stainless-steel operations remain critical to the industry and continue to dominate commercial manufacturing. Yet, adoption of single-use (SU) manufacturing systems has benefited biopharmaceutical companies and their CDMO partners through enhanced operational flexibility and reduced costs. This adaptability and affordability — combined with highly effective product changeover, plug-and-play operations, and the elimination of a majority of cleaning processes — is advantageous to biopharma companies whose products are suitable for SU processes.

SU systems, either as part of fully SU process or a hybrid approach combining stainless-steel and SU, represent a new paradigm in the evolution of bioprocessing technology.

Accordingly, companies that decide to utilize SU systems should understand the process control and regulatory elements of that decision. Adherence to new and emerging requirements for SU systems — including systematic extractables & leachables (E&L) studies, cumulative effect assessment, toxicological evaluations, and SU system manufacture under control — can be difficult, if they are not well understood and planned in advance.

Explore the considerations for E&L studies when utilizing SU systems and the elements of strong supply chain management for SU success.