Division of Microbiology Assessment: Organizational Overview and Recommendations for Nonsterile Products

White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing

1. Introduction

Container closure integrity (CCI) is the ability of acontainer closure system to maintain the sterility and product quality of sterile final pharmaceutical, biological, and vaccine products throughout their shelf-life. It is a regulatory requirement that the design of a container closure system b qualified. There are multiple methods available to qualify the effectiveness of a selected container closure system as detailed in industry guidance and literature. Selection of an appropriate method is based on the container closure system to be qualified and its contents. The norma variation within the manufacturing process should be taken into consideration when qualifying the integrity
of the closure system.

Container Closure Integrity Evaluation for Sterile Product Packages

P5: Container Closure Integrity Assurance throughout Manufacturing Processes

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