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Best Practices for Qualifying Single-Use Assemblies

Key aspects of single-use assembly qualification including quality by design (QbD), quality risk management (QRM) and operator handling and training.

Extractables and Leachables Risk Assessment for Single-Use Systems

Before adoption of single-use technologies in biomanufacturing, manufacturers must assess the risk to the drug product from potential leachables. This article highlights a general approach based on the United States Pharmacopeia (USP).