Evaluating single-use systems for extractables and leachables BY DR TIM SANDLE | PHARMACEUTICAL MICROBIOLOGY AND CONTAMINATION CONTROL EXPERT 9th December 2024 Ref: Sandle, T. (2024) Evaluating single-use systems for extractables and leachables, RSSL, Life Sciences, 9th December 2024: https://www.rssl.com/insights/life-science- pharmaceuticals/evaluating-single-use-systems-for-extractables-and-leachables/ Sterile single-use disposable technologies present considerable advancements for pharmaceutical manufacturing, improving process design and reducing turnaround times. These technologies will have described chemical, toxicological, physical, morphological and mechanical properties. Despite their many advantages, there are also potential draw backs which must be appropriately evaluated(1). One consideration is with the evaluation of foreign impurities that can arise due to contact between the product and single-use systems. These foreign impurities (leachables or extractables) are compounds that are leached from these systems upon