The quick and efficient aseptic filling transfer of highly valuable and at the same time extremely sensitive drug substances is a critical process step. While in the past pharmaceutical and especially biopharmaceutical manufacturers have relied on stainless-steel tanks and rigid systems as the go-to choice for process steps like filling, single-use technologies are taking over.
Not only are they becoming widely accepted, but they have in parts already been established as industry standards. They abolish the need for cleaning, and the chosen materials offer a degree of flexibility that was unknown in the past.
While single-use solutions may offer new levels of flexibility, they come with their own set of challenges, mainly based on the fact that certain single-use components, like bags, are more prone to ruptures and leakages than traditional stainless-steel containers. However, CMOs have recognized the need for reliable protection and come up with viable solutions to reduce the risk of contamination.
Another pain point of modular single-use systems is their increased number of ports and interfaces, leading to more need for human interaction, which can, naturally, lead to human error. But if these issues are dealt with, the adoption of single-use tubing systems and piping can present biopharma manufacturers with a welcome alternative to traditional - and traditionally inflexible - systems.