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Medical Products Stability Tests (Shelf Life)

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  • Medical Products Stability Tests (Shelf Life)

Since medical products have a long shelf life, accelerated shelf life testing is preferred for these products.

"ASTM F 1980 standard" is used for accelerated shelf life test in medical products.

According to this standard, the structure of the product, the temperature it can withstand the packaging properties, the real-time shelf life time are taken into account and how long the fast aging time of the product corresponds to is formulated and calculated.

In general, it is recommended to apply the test temperature to 60 ° C and below for accelerated shelf life testing in medical products.

The temperature to be selected varies according to the properties and composition of the product. (Softening temperature of the material, material transition and any possible deterioration temperatures)

There is no value determined for humidity in the accelerated shelf life test. Firms should indicate this if they have a specific moisture value for them.

With the help of other microbiological and physicochemical tests performed after the accelerated shelf life test, it will be determined whether the medical products kept at the temperature revealed in the calculation are suitable for the specified shelf life in a shorter time.