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PDA Journal Article - Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity

Discusses major risks associated with CCI, a risk-based approach to mitigating them, and the need to understand each drug application's acceptable MALL.

This paper takes a holistic review of all the major considerations needed in qualifying a new vial system for container closure integrity.

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PDA Journal Article - Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity

Discusses major risks associated with CCI, a risk-based approach to mitigating them, and the need to understand each drug application's acceptable MALL.

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