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Container Closure IntegrityContainer Closure Integrity Control versus Integrity testing during Routine Manufacturing2PDA J Pharm Sciand Tech 2015, 69 461-465Current Requirements:CCI demonstration is required throughout the lifecycleInitial CCI qualification/validation requirements are well definedFused packages require 100% Integrity testingFor other Container types, in-process Integrity testingis not a regulatory requirementScope:Drug product manufacturing of sterile injectables including: Vials Syringes IV Bags Inhalation ProductsFocus:Holistic Control of CCI3In-Process Controls100% Integrity Testing4Package EngineeringCommercial ManufacturingManufacturing Science and TechnologyQuality and Regulatory DepartmentsCommunicationAn Integrated Holistic System5An Integrated Holistic System6An Integrated Holistic System7An Integrated Holistic System8An Integrated Holistic System9An Integrated Holistic

100% integrity testing. For other container types, in-process integrity testing is not a regulatory requirement. Scope: Drug product manufacturing of ... • Assurance of container closure integrity is expected to be built into the manufacturing process, as part of a holistic system

  Testing, Closures, Container, Integrity, Container closure integrity, Testing integrity