Accelerated Shelf Life Testing

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Shelf Life Estimation Of Pharmaceutical Products Pharmaceutical Life Guidelines

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In polymers testing may be done at elevated temperatures to produce a result in a shorter amount of time than it could be produced.

Accelerated shelf life testing.

This process is performed using the q10 value. Accelerated life testing is the process of testing a product by subjecting it to conditions in excess of its normal service parameters in an effort to uncover faults and potential modes of failure in a short amount of time. This testing methodology is universally called accelerated shelf life testing aslt and when properly applied allows a reduction in the time needed to estimate product shelf life. Accelerated aging temperature c typical values are 50 c 55 c and 60 c.

By analyzing the product s response to such tests engineers can make predictions about the service life and maintenance intervals of a product. Accelerated shelf life testing. Accelerated shelf life test real time assessment is usually time and resource consuming. Accelerated aging test for shelf life validation.

This means of testing is advantageous as results are obtained in a significantly shorter period of time than waiting for results after the actual shelf life of the product. Elevated temperature are applied to eligible products to predict product shelf life at typical storage conditions. Values above 60 c are not recommended. Accelerated shelf life testing aslt kilcast and subramaniam 2000 can be incredibly useful when setting a shelf life for an ambient product as the developer does not need to wait for the whole of the product s shelf life to determine the end of shelf life.

In these studies accelerated conditions i e. Accelerated aging time calculator astm f1980 07. The food industry has a great need to have a shelf life test in the minimum time possible because of the fierce competition sudden shortage of agricultural inputs opportunity loss and low unit value of the commodity. The product is then evaluated at specific intervals to monitor any potential degradation in quality or food safety.

Using state of the art stability chambers our shelf life testing protocols ensure that products are kept at specific temperatures and humidity levels throughout the duration of the study. For example storage at a higher temperature can result in a prediction in say half the time of the real shelf life although some methods claim to deliver the information in substantially less time. Assessing shelf life using real time and accelerated stability tests biopharm international biopharmaceutical products in storage change as they age but they are considered to be stable as long as their characteristics remain within the manufacturer s specifications. Elevated temperature or humidity are applied to eligible products to predict product shelf life over extended periods of time up to 1 year.

In these studies accelerated conditions i e. Shelf life to be simulated days days. Real time aging test results are used to verify accelerated aging evaluations and together are used to determine final shelf life claims values.

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