Description

Freezing of a drug can result in a number of problems. A medication may need to be replaced once it has been frozen.


 

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.

Delivery System

Complication After Freezing

liquid in ampoule

hairline fracture of glass, with contamination, leakage or oxidation

liquid in other glass container

expansion of liquid with shattering of container

suppository

fragmentation into pieces

capsule

crack or break

 

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)

 


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