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Evolution of Container Closure Integrity Testing

Summary: The USP general chapter <1207> “Package Integrity Evaluation – Sterile Product” deeply changes the way it considers the Container Closure Integrity Testing (CCIT) within the pharmaceutical industry. Performing only the traditional CCIT by Dye Ingress is no longer in line with the USP expectations for a container closure integrity assessment.

This poster explains the changes related to the new USP <1207> and the associated actions to implement to remain compliant. A risk analysis based on Quality by Design is developed. An improvement of the traditional Container Closure Integrity Testing, compliant with the ICH and the new USP, is proposed.

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