USP1207 包装完整性评估—无菌产品.pdf

First Supplement to USP 39–NF 34 General Information / á1207ñ Package Integrity Evaluation—Sterile Products 1 Change to read: á1207ñ PACKAGE INTEGRITY EVALUATION—STERILE PRODUCTS 1. INTRODUCTION This chapter provides guidance on the integrity assurance of nonporous packages intended for sterile pharmaceutical prod- ucts. Background instruction is provided on the topics of leaks, leakage rate, and package sealing/closure mechanisms. Explan- ation is given as to how packages that conform to specified leakage limits help to ensure the contained product meets and maintains sterility and relevant physicochemical specifications. The integration of package integrity assurance as a key compo- nent of the entire product life cycle is stressed. Guidance in the selection, validation, and use of leak test methodologies as well as package seal quality tests is included. Detailed recommendations are presented in three subchapters listed below: • Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation á1207.1ñ • Package Integrity Leak Test Technologies á1207.2ñ • Package Seal Quality Test Technologies á1207.3ñ At the end of this chapter, the Glossary section defines terms as they are used in the context of this set of four general infor- mation chapters. The term product–package refers to the container–closure system plus the product contents. The container–closure system consists of the primary packaging components, those components that are or may be in intimate contact with the product, as well as secondary packaging components vital to ensuring correct package assembly, for example, the aluminum cap used to seal a stoppered vial package. Suitable container–closure systems adequately store and protect the contained pharmaceutical product. Thus, sterile prod- uct–package integrity is the abili