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Pharma Stability: Insights, Guidelines, and Expertise

Tag: vaccine cold chain excursion

Risk Mitigation Strategies for Cold Chain Excursion in Injectables

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Risk Mitigation Strategies for Cold Chain Excursion in Injectables Risk Mitigation Strategies for Cold Chain Excursion in Injectable Pharmaceuticals Cold chain excursions—temporary deviations from the required refrigerated storage conditions—pose a significant threat to the stability, efficacy, and safety of injectable pharmaceutical products. From vaccines and biologics to small-molecule injectables, temperature-sensitive formulations must be protected throughout…

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Freeze-Thaw and Thermal Cycling Studies, Stability Testing Types

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  • Match Stability Study Container-Closure Systems to Final Market Packaging

    Understanding the Tip: Why container-closure systems matter: Stability testing simulates how a drug product will behave over its shelf life.
    If the container-closure system used… Read more

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