In general, stability tests are performed to determine or verify the shelf life of a food, cosmetic or medical product. In these tests, it is expected that the products will be in a suitable microbiological condition and there will be no deterioration in their physicochemical structure.
Stability tests are performed in two ways. One method is to soak the product for its normal shelf life and monitor the results. One method is to try to get results in a shorter time by changing the environmental conditions and creating real environmental conditions. This second method is generally called accelerated aging tests.
Aging tests in medical products are generally carried out as an accelerated shelf life and these tests comply with the ASTM F1980 standard developed by the American Testing and Materials Organization (ASTM).
Briefly, shelf life is commonly calculated using results from both real-time stability and accelerated stability tests. In real-time stability testing, a product is stored under recommended storage conditions and monitored until it exceeds product specifications. In accelerated stability testing, a product is stored under high stress conditions, for example, high temperature or high humidity environments. The deterioration at recommended storage conditions is then calculated using known relationships between the acceleration factor and the degradation rate.
Real-time stability studies are seen as the gold standard in determining the expiration date and shelf life of the product. In this approach, the product is stored under recommended storage conditions and followed until it exceeds the specification. In this regard, the test period has to be long enough to allow adequate enzyme degradation under storage conditions.
Some products change over time as they sit in storage, but products are considered stable as long as their performance characteristics remain within the manufacturer's specifications. The term shelf life refers to the period during which a product remains stable when stored in accordance with the conditions recommended by the manufacturer. In particular, food manufacturers need to accurately determine the shelf life of their products to comply with regulations and keep consumers safe.
Our organization also provides real-time stability testing services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
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