1. INTRODUCTION

This chapter provides guidance on the integrity assurance of nonporous packages intended for sterile pharmaceutical products. Background instruction is provided on the topics of leaks, leakage rate, and package sealing/closure mechanisms. Explanation 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 component 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 〈1207.1〉

• Package Integrity Leak Test Technologies 〈1207.2〉

• Package Seal Quality Test Technologies 〈1207.3〉