A risk based approach towards the assessment of process equipment related leachables - case study

Manufacturing processes are composed of a complex set of plastic materials that may introduce process-equipment related leachables (PERLs) into the final product, thereby potentially compromising its biocompatibility, safety or quality. At the same time, not all manufacturing components have the same likelihood to contribute to PERLs. A risk-based approach in which process conditions, type of process material and composition of the process solution are evaluated, allows to define relevant test requirements with respect to extractables and leachables. In this presentation the main principles of such a risk-based evaluation are highlighted by means of a case study.

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