This Technical Report was prepared by PDA Task Force on Container/Closure Integrity.

This report reviews issues of pharmaceutical product package integrity and provides guidance for evaluating the barrier qualities of a pharmaceutical package. It supersedes the previously issued PDA Technical Information Bulletin No. 4, Aspects of Container/Closure Integrity.

Although it is written to reflect the complexity of all pharmaceutical products and packages, the emphasis throughout the document is clearly on packaging intended for sterile products. The information provided in this guideline is intended to assist users in developing integrity assessment strategies for use during the phases of product life.

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Table of Contents:

1. Preface
2. Introduction
3. Integrity Assurance Through Product Development And Product Life
4. Package Integrity and Leak Rate Specifications
5. Test Method Selection
6. Methods of Establishing Microbial Package Integrity
7. Decision Tree
8. Leak Test Methods
9. Bibliography