Single-use systems (SUS) come with increasingly complex challenges that are often misconceived since industry is still in the early stages of adopting this technology. One of the more complicated SUS aspects is sterilization validation. A successful validation requires strong collaboration early in the manufacturing process design phase among all parties involved.

The pharma firm, the SUS manufacturer, the contract sterilization vendor and the contract microbiology laboratory each play a part within the validation process. This partnership ensures shared understanding between all four players on the inherent complexity, uncertainty and resource demand in SUS design, validation and commercial manufacturing. Additionally, common misconceptions, false assumptions and veiled communication between the pharma firm and the SUS manufacturer must be highlighted, brought into the open and addressed. Such open collaboration cultivates invaluable knowledge transfer, greatly minimizing risk of SUS failures later on.