PDA Letter Article

An Overview of Container Closure Integrity

by Qingyu Zeng, PhD, West Pharmaceutical Services, Inc.


Considerations for Achieving an Optimal Performance Window for Container Closure Systems

[Editor’s Note: This is based on the author’s presentation at the 2018 PDA Container Closure Performance and Integrity Conference.]

A typical container closure system has three major components: a rubber stopper, a vial and an aluminum seal. In order to satisfy mandatory patient safety requirements, container closure integrity must be ensured through a holistic consideration of many critical aspects (1).