The method used for shelf life testing in medical products is ASTM F 1980 standard.
According to this standard, the fast aging time of the product is calculated by taking into consideration the temperature and real-time shelf life of the product according to its structure and packaging characteristics.
An example calculation is shown below.
Product real-time shelf life: 2 years (730 days)
Temperature at which the product will be analyzed: 60 ° C
Stability Test Analysis Time: 52 days
At the end of this period, performance tests and physicochemical and microbiological tests are performed.
The stability test should prove the integrity of the product. For stability testing, it is recommended that the test temperature be applied at temperatures of 60 ° C and below.
The properties and composition of the material are very important as to which temperature to choose. (The softening temperature of the material; the transition of the material and the temperatures that may cause all kinds of deterioration)
The aim of the stability test and all subsequent tests; to show whether there are any problems with the continuity of the sterile barrier systems of the product.
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