Understand how USP <665> is shaping material qualification for single-use systems
Single-use systems are widely used in pharmaceutical and biopharmaceutical manufacturing, but their materials must be evaluated carefully to control extractables and leachables risk. As regulatory expectations evolve, manufacturers, suppliers and quality teams need a clear approach to material qualification, risk assessment and analytical strategy.
In this white paper, we explain the role of USP <665> and its relationship to USP <1665>, USP <1663>, USP <1664> and emerging global expectations. We show how a standardized extraction protocol can support risk-based qualification, strengthen documentation and help you assess the connection between extractables data, analytical evaluation thresholds and potential leachables in the finished product.
What you’ll find in our white paper
- How USP <665> fits into the wider regulatory framework
Understand how USP <665> connects with related pharmacopeial chapters, international standards and evolving expectations for material qualification in pharmaceutical manufacturing.
- What risk-based qualification looks like in practice
See how we outline the practical use of risk classification, extraction protocols and material assessment for plastic components used in single-use systems.
- How to approach extractables and leachables correlation
Learn how extractables data can be normalized, scaled and compared with analytical evaluation thresholds to support leachables risk assessment.
- What to consider when applying industry and regulatory expectations
Explore the differences between compendial requirements and industry best practices, including the role of alternative extraction protocols and their place in compliance strategies.