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Pharma Stability: Insights, Guidelines, and Expertise

Tag: closure integrity sterile assurance]

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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  • Align Stability Testing with Label Claims to Ensure Scientific and Regulatory Consistency

    Understanding the Tip: Why label-linked stability testing is essential: Pharmaceutical labels convey critical information that governs product handling, administration, and storage.
    Claims such as “Protect… Read more

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