Now that single-use technology plays a part in nearly all bio-production processes, what is next? Several challenges remain that are still serious enough to delay or even stop the use of single-use technology, which in turn can extend the time to market and increase the cost of lifesaving biopharmaceutical products. Of the existing difficulties, which five are the most critical?

This paper considers five existing challenges in the implementation of single-use technology including scale, automation, product compatibility and compliance, speed and supply chain, and integrity and examines ways in which they can be surmounted.

Single-use automation and its use to improve product quality by reducing process variation is also discussed with the help of a case study that looks at a project to automate a labour-intensive bulk filling operation which was able to achieve payback within one year. The operation was automated with a fully enclosed filtration and dispensing system which improved product and process safety, simplified the process, reduced labour costs and reduced the risk associated with transportation of the product.