Summary: Single Use Systems (SUS) present challenges with regards to extractables and leachables, however their ease of use, quick change out capability, cost, and configurational flexibility provide significant advantages over traditional manufacturing set-ups. With these challenges regarding E&L, much attention has been paid to extractables data generation for use in vendor and material selection.
Ongoing discussions in the industry revolve around the BioPhorum Operations Group (BPOG) Standardized Extractables Testing Protocol for Single Use Systems in Biomanufacturing and the proposed USP 665; monograph for single-use systems. Regardless of how these discussions resolve amongst the industry, after an SUS is selected there is still testing that must be performed. The data generated during selection is often not robust enough for qualification of the SUS materials for use in the manufacturing setting. It is critical to perform extractables testing of the SUS for material compatibility using the manufacturing conditions of use, including time and temperature. This extractables testing also should be performed using the actual solutions contacting each SUS material. Case study examples of extractables testing for material compatibility and qualification will be presented.
Presenter: Eric Hill joined Boston Analytical in 2014 as Director of the Extractables & Leachables laboratory. Prior to Boston Analytical, Eric spent 15 years at a contract analytical laboratory in various roles including Analytical Scientist, Business Development Manager, Business Manager, and finally President. Eric has an extensive background in polymer material characterization and contributes to industry groups and technical conferences in the E&L space. He holds a bachelor’s degree in chemistry from the University of Michigan, a master’s degree in analytical chemistry from Central Michigan University, and an M.B.A. from the University of Michigan.