TR 2020/226: Improving Container Closure System Selection Using Comprehensive Stack-Up Analysis

This report focuses on component machineability, illustrating a method to quantify the probability of successful assembly based on component dimensional data.

Selecting the right combination of vial container closure system components in conjunction with a suitable capping process significantly impacts Container Closure Integrity, visual acceptance of the product and patient safety. Many factors influence component selection during the drug development process. These include drug-packaging chemical interactions, component machineability, shelf life, and storage conditions.

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