Accelerated Aging is a key component of the overall packaging validation for medical devices.
Following ISO 11607, a package validation is accelerated aging and the corresponding integrity testing as well as simulated distribution and its subsequent integrity testing.
A comprehensive packaging validation looks at accelerated aging and simulated distribution as separate components and each require their own set of samples. The total package validation will pool the data from accelerated aging and simulated distribution in order to provide device manufacturers’ a complete validation of their package configurations.
Accelerated aging serves as key interim data to support product shelf life dating until real time data is available. One way we would work with you is, at times and if chamber space would allow, by providing recommendation to age additional samples. This additional aging may be useful in the future to support extending a shelf life or supplemental data in the event of an issue in the future.
In addition, our technical experts continue to leverage their experience with a broad range of products and industry experience to provide education on test strategies or suggestions as to how to approach a reported test failure. As is true with our approach to custom studies and our consultation on preclinical device safety testing, our services are a holistic approach and partnership with you to understand your product and recommend a strategy that is best for you.
To speak with our technical and regulatory experts, contact us today to arrange a meeting.
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