USP 1207.1 包装完整性和测试方法选择（中英对照）.doc

PAGE2 / NUMPAGES2 <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> provides an overview of “leak test” methodologies (also termed technologies, approaches, or methods) as well as “package seal quality tests” useful for verification of sterile product package integrity. More detailed recommendations for the selection, qualification, and use of leak test methods are presented in three subchapters 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： Package Integrity and Test Method Selection <1207.1>包装完整性和测试方法选择 Package Integrity Leak Test Technologies < 1207.2>包装完整性泄漏测试技术 Package Seal Quality Test Methods < 1207.3>包装密封质量测试方法 At the end of chapter Sterile Product Packaging—Integrity Evaluation <1207>, the Appendix: Definitions section defines terms as they are used in the context of this set of four general information chapters. 在《无菌产品包装-完整性评估1207》一章的末尾，“附录：定义”部分定义了在这套四个常规信息章节的上下文中使用的术语。 This chapter Package Integrity and Test Method Selection <1207.1> discusses sterile package integrity assurance, provides information about package leaks, and describes a range of package integrity test methods. Package integrity verification occurs during three product life cycle phases: 1) the development and validation of the product–package system, 2) product manufacturing, and 3) commercial product shelf-life stability assessments. 本章包装完整性和测试方法选择<1207.1>讨论无菌包装完整性保证，提供有关包装泄漏的信息，并介绍一系列包装完整性测试方法。 包装完整性验证在三个产品生命周期阶段进行：1）产品-包装系统的开发和验证，2）产品制造，以及3）商业产品货架寿命稳定性评估。 PACKAGE INTEGRITY AND TESTING DURING PRODUCT LIFE CYCLE 产品生命周期中的包装完整性和测试 Appropriate packaging for a sterile product can be determined on the basis of a knowledge-gaining effort conducted during the product's life cycle. Package design fitness-for-use is incorporated into a packaging system by selecting the most appropriate components and packaging assembly. Adherenc