Effective Management of E&L Risk Evaluation to Streamline SUT Implementation

Figure 1: Leachables risk evaluation

Single-use technologies (SUTs) can introduce leachables (chemicals that migrate from polymeric components into the drug product) to a manufacturing process. Herein, we describe an effective process to manage the risk from leachables to ensure patient safety and prevent delayed product launch. Early implementation of leachables risk evaluation strategies can reduce the resources and time required for risk mitigation later in a project’s life cycle.

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