Accelerated Shelf Life Testing

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.

Accelerated shelf life testing.

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. Real time aging test results are used to verify accelerated aging evaluations and together are used to determine final shelf life claims values. Accelerated aging temperature c typical values are 50 c 55 c and 60 c. This process is performed using the q10 value.

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. Accelerated aging time calculator astm f1980 07. 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. Accelerated aging test for shelf life validation.

Shelf life to be simulated days days. Elevated temperature are applied to eligible products to predict product shelf life at typical storage conditions. Shelf life studies can come in many different forms including accelerated studies. Accelerated shelf life test real time assessment is usually time and resource consuming.

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. In these studies accelerated conditions i e. 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. Accelerated shelf life testing.

Storage temperature to be simulated c typical values are between 20 c and 25 c c. 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. The resulting expiration date or shelf life from accelerated aging testing is considered a conservative estimate. By analyzing the product s response to such tests engineers can make predictions about the service life and maintenance intervals of a product.

Values above 60 c are not recommended. In polymers testing may be done at elevated temperatures to produce a result in a shorter amount of time than it could be produced. 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.