USP38-1207.1 包装完整性和检验方法选择.docxVIP

2014年9月26日 PF Online BRIEFING 《 1207.1 〉 Package Integrity and Test Method Selection. This proposed new general chapter describes a range of package integrity test methods that are used for ensuring sterile package integrity. Different types of package defects that cause leaks are described, and information about their detection is provided. Limit of detection is discussed in detail for the different leak test methods. Chapter《 1207.1 〉 is part of a set of related chapters; for additional information, refer to the Briefing for Sterile Product Packaging—Integrity Evaluation《 1207 〉. (GCM: R. Tirumalai.) Correspondence Number—C147436 Comment deadline: November 30, 2014 Add the following: 《 1207.1 〉 PACKAGE INTEGRITY AND TEST METHOD SELECTION INTRODUCTION 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: Pack age Integrity and Test Method Selection 1207.1《〉 Pack age Integrity Leak Test Technologies 1207.2《〉 Pack age Seal Quality Test Methods 1207.3《〉 At the end of chapter Sterile Product Pack aging—Integrity Evaluation 1207《〉, the Appendix: Definitions section defines terms as they are used in the context of this set of four general information chapters . This chapter Pack age 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 manufacturin