Exposure to freezing temperature may occur during:
(1) shipping during the winter
(2) winter expedition
(3) storage in a vehicle over winter
(4) malfunction of a refrigerator
(5) accident
A liquid may freeze at different temperatures depending on the formulation, from 0°C to -20°C.
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Delivery System
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Complication After Freezing
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liquid in ampoule
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hairline fracture of glass, with contamination, leakage or oxidation
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liquid in other glass container
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expansion of liquid with shattering of container
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suppository
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fragmentation into pieces
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capsule
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crack or break
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Compounds that may breakdown or deteriorate after freezing:
(1) protein solutions (insulin, other)
(2) emulsions
(3) metal-organic compound
Additional risk factors for deterioration:
(1) repeated episodes of freezing and thawing
(2) wide swings in temperature (can happen in airplanes)
(3) vibration or sudden impact (can shatter something brittle)
