Manufacturing & Analytical Characterization
Eric Hill, MS MBA
Chief Scientific Officer - Chemistry and Extractables & Leachables Labs
BA Sciences
Salem, New Hampshire
Description: Single Use Systems (SUS) present challenges with regards to extractables and leachables (E&L), 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. The BioPhorum Operations Group (BPOG) Standardized Extractables Testing Protocol for Single-Use Systems in Biomanufacturing offers guidance for generating standardized extractables data for use in component comparison and selection. Also relevant is component and material qualification once a component has been selected for use in a manufacturing system. The data generated during selection is not robust enough for qualification of the SUS materials for use in the manufacturing setting. The proposed USP < 665> chapter Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products offers guidance in qualification of components. Both of these test protocols will be reviewed, and a guide map for successful selection, qualification, and implementation of single use system components from an E&L perspective will be presented.