USP <665> provides a thorough explanation of the potential E&L complications from implementing single-use components in a manufacturing process as follows. Mandatory compliance with USP Chapter <665> is expected as it will become official on May 01, 2026. It is imperative for manufacturers to begin preparing now to ensure full compliance and avoid any disruptions when the new standards come into effect.

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https://info.solvias.com/usp665-white-paper