Evolution of Container Closure Integrity Testing
Summary: The USP general chapter <1207> 鈥淧ackage Integrity聽Evaluation 鈥 Sterile Product鈥 deeply changes the way it聽considers the Container Closure Integrity Testing (CCIT)聽within the pharmaceutical industry. Performing only the聽traditional CCIT by Dye Ingress is no longer in line with聽the USP expectations for a container closure integrity聽assessment.
This poster explains the changes related to the聽new USP <1207> and the associated actions to聽implement to remain compliant. A risk analysis based聽on Quality by Design is developed. An improvement of聽the traditional Container Closure Integrity Testing,聽compliant with the ICH and the new USP, is proposed.