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首页> 外文会议>Annual International Conference and Seminar >The importance of compendial testing of medical polymers in the pre- and post-market evaluation of medical devices and pharmaceutical containers
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The importance of compendial testing of medical polymers in the pre- and post-market evaluation of medical devices and pharmaceutical containers

机译：医疗聚合物在医疗器械和药物容器后市场评估中的医疗聚合物的重要性测试的重要性

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The use of compendial testing in the pre-market and in the post-market phase of a medicinal product is demonstrated. Recently the use of compendial testing in the quality control of e.g. medical plastics is getting more attention. In a first part the regulatory aspects for plastic materials intended to be used for the packaging of active substances and medicinal products are summarized, more particularly the corresponding FDA and EMEA-guidelines. The latter guideline will be discussed in more detail, e.g. the decision tree for the plastic packaging material for the active substance and the drug product. An important item within this guideline are the tests for packaging materials which are described in the European Pharmacopeia, e.g. PVC, PE, silicone, … One compendial test will be elaborated, more specifically E.P. 3.1.5 for Polyethylene with additives. Finally some conclusions concerning the use of compendial testing will be made.
机译：证明了在市场前和在药品后市场阶段的使用进行了蛋白测试。最近在例如，在质量控制中使用蛋白测试。医疗塑料更加关注。在第一部分中，总结了用于包装活性物质和药品包装的塑料材料的调节方面，更具体地，特别是相应的FDA和EMEA-指南。后者将更详细地讨论后一条指南。用于活性物质和药物产品的塑料包装材料的决策树。本指南中的一个重要项目是欧洲药典中描述的包装材料的测试，例如，欧洲药典。 PVC，PE，硅胶，......一个重要测试将更具体地详细说明。 3.1.5用于添加剂的聚乙烯。最后，将进行一些关于使用竞选测试的结论。

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