Stability Test (Shelf life):
Stability tests are generally tested to determine/verify the shelf life of the product. Stability tests are expected to include no deterioration in the physical structure of the product and is microbiologically appropriate.
Stability tests can be carried out both by waiting for the product during normal shelf life and by changing the ambient conditions (such as increasing the temperature to accelerate). Stability tests by increasing temperature are also called accelerated aging tests.
Accelerated aging test is exposed to temperatures higher than normal shelf life temperature, shortening the test time and resulting in this in less time
Aging tests in medical products are mostly accelerated aging testing. The method used for shelf life testing in medical products is the ASTM F 1980 standard.
Bu standarda göre ürünün yapısı ve ambalaj özelliklerine göre dayanabildiği sıcaklık ve gerçek zamanlı raf ömrü süresi hesaba katılarak yapılan hesaplama sonucunda ürünün hızlı yaşlandırma süresinin ne olduğu hesaplanır.