Accelerated aging tests are conducted to model potential changes in the sterile integrity of sterile barrier systems (SBS) and the physical properties of packaging materials over time. These tests are designed to evaluate the performance of sterile barrier systems and ensure that products remain sterile throughout their shelf life.
Accelerated aging methods are applicable not only to sterile barrier systems but also to medical devices and the materials used in their production. Test results play a critical role in determining whether products meet durability and reliability standards.
At Nioreg Laboratory, samples are stored under specified temperature and humidity conditions in compliance with the ASTM F1980 standard, considering their physical and chemical properties. It is essential to select samples based on statistical justification to ensure that stability studies represent all manufactured products.
To learn how we can assist with creating an accelerated aging protocol and conducting related tests, please complete this form and send it to info@nioreg.com
