USP<1207> PACKAGE INTEGRITY EVALUATION—STERILE PRODUCTS

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>

At the end of this chapter, the Glossary section defines terms as they are used in the context of this set of four general information 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 product–package integrity is the ability of a sterile product container–closure system to keep product contents in, while keeping

detrimental environmental contaminants out. Specifically, leaks of concern for sterile product–packages include the following

three categories described in Table 1. In other words, the leaks of concern for a given product–package are a function of the

degree of package protection demanded by the product to ensure that all relevant product physicochemical and microbiological quality attributes are met through product expiry and use.

RTU(ready to use) 2ml COP vial

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