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Pharma Stability: Insights, Guidelines, and Expertise

Tag: CCI biologics

Container Closure Integrity Testing in Biologic Stability Studies

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Container Closure Integrity Testing in Biologic Stability Studies Ensuring Sterility and Stability: Container Closure Integrity Testing for Biologics Container Closure Integrity Testing (CCIT) is an essential part of biopharmaceutical product development, ensuring that the packaging system maintains its barrier properties throughout the product’s shelf life. For sterile biologic products—particularly parenterals—container closure integrity (CCI) directly impacts…

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  • Leverage Design of Experiments (DoE) in Early Stability Study Planning

    Understanding the Tip: What is DoE in the context of stability studies: Design of Experiments (DoE) is a structured, statistical approach to determine the relationship… Read more

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