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<1207.1> PACKAGE INTEGRITY AND TEST METHOD SELECTION USP 1207.1包装完整性和测试方法选择 INTRODUCTION介绍 Chapter <1207> providesan overview of “leak test” methodologies (also termed technologies, approaches,or methods) as well as “package seal quality tests” useful for verification ofsterile product package integrity. More detailed recommendations for theselection, qualification, and use of leak test methods are presented in threesubchapters that address these specific topics: 第1207章概述了“泄漏测试”方法(也称为技术,方法或方法)以及“包装密封质量测试”,可用于验证无菌产品包装的完整性。 关于泄漏测试方法的选择,鉴定和使用的更详细的建议,在以下三个子章节中进行了介绍,分别针对这些特定主题:
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