By Robert Roy and Jason Collins, IPS
Single-use disposable systems (SUDS) for aseptic fill/finish units promise to save pharmaceutical manufacturers valuable time, streamlining operations as well as shortening project schedules. Incorporating SUDS can also offer regulatory compliance and environmental, health and safety (EHS) benefits as well as facility design advantages.
Bulk biotech operations have successfully deployed single-use systems for buffer and media preparations for some time, and they are currently implementing new single-use technologies such as fermentation and chromatography systems. Recent advances in technology are making SUDS increasingly attractive for aseptic operations. A single-use line is a particularly good fit for parenteral solution products with relatively low batch sizes (50L to 500L) that can be transferred by peristaltic pump.
Learn how today’s disposable systems offer improved manufacturing efficiency, and better QA and regulatory compliance — and they can be the fastest route to media fills.