Testing Freeze-Thaw Effects on Drug-Device Combination Products
Testing Freeze-Thaw Effects on Drug-Device Combination Products Evaluating Freeze-Thaw Effects on Drug-Device Combination Products: A Regulatory and Functional Guide Drug-device combination products—such as prefilled syringes, autoinjectors, insulin pens, and patch pumps—combine pharmaceutical and mechanical components into a single therapeutic system. These products face unique challenges under freeze-thaw and thermal cycling conditions. Regulatory authorities including the…
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