Single-use biomanufacturing is a rapidly growing industry. In recent years, single-use centrifuges have become viable alternatives to traditional filters, promising 90% reductions in waste materials and improvements in process time and yield. However, these systems often have several fluid paths with different materials, complicating extractable studies This case study describes how the risk assessment of the first-to-market single-use disc-stack centrifuge was conducted. This study shows how a dramatic modification of the surface-area-to-volume extraction ratio was required for the single-use system and how this was considered during interpretation of the results respecting industry best practice. Furthermore, it's demonstrated how the detection of volatiles can vary depending on the approach of analysis, surface coatings, and where analytical study design should be considered to mitigate missing volatile extractables.
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