Tag: Temperature Excursion

Maintain Backup Stability Chambers to Prevent Data Loss in Case of Failure

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Understanding the Tip: Why backup chambers are essential: Stability chambers are critical infrastructure in pharmaceutical QA. A sudden malfunction—due to power failure, temperature controller breakdown, or refrigerant issues—can jeopardize months or years of collected stability data. Having backup chambers validated and ready allows immediate transfer of samples, minimizing data loss and avoiding major protocol deviations….

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Stability Study Tips

Always Record Even Minor Deviations from Storage Conditions in Stability Studies

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Understanding the Tip: What qualifies as a deviation: Any fluctuation outside the validated storage conditions—whether temperature, humidity, or light exposure—constitutes a deviation. Even brief or minor excursions can affect product stability, especially for sensitive formulations. Ignoring small changes may compromise the reliability of the data and lead to misleading conclusions about product shelf life. Why…

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Stability Study Tips