Whitepaper - Reviewing Single Use Technology (SUT) Extractables and Leachables (E&L) Testing — USP <665>, USP <1665> and BPOG Extractables Protocol

This white paper aims to provide an easy-to-understand insight into USP <665>, USP <1665> and BioPhorum standards and protocols. Smithers Medical Device Testing is an FDA registered testing laboratory providing high-touch studies with in-house, global expertise in analytical chemistry, materials, and device performance. Our team have access to state-of-the-art laboratory equipment to meet the needs of the industry.

Risk management is critical in the evaluation of SUT so that processes are appropriately designed, safe and resources are focused on areas of the greatest risk. USP <665> is mandatory on May 1, 2026 and therefore businesses need to be ready for this implementation and how it will affect them.

The test protocol of USP <665> and BPOG, although standardised, still requires expert knowledge of E&L testing, materials and biopharmaceutical and pharmaceutical manufacturing. Smithers has invested significantly in equipment and people to meet the needs of our clients.

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