Can the product shelf life testing be done at the same time as the stability study for the sterile barrier?

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The medical device package shelf life testing and the stability study should be done separately. The FDA defines shelf life as the term or period during which a device remains suitable for its intended use. Fitness for use can be impacted by both maintaining sterility of the package and the post-aging performance characteristics of the medical device. These are two separate items and should be tested separately. The temperatures that are appropriate for sterile barrier system (SBS) materials may not be applicable to device materials. This may jeopardize the otherwise successful stability study on the SBS. When device assembly is completed and the product is packed within the SBS during stability studies, they often interfere with many of the tests that are conducted on the SBS at each aging interval. Medical devices often have a functional shelf life, which is much less than that of the SBS. These device limitations would unnecessarily shorten the dating claims for future products using the same SBS materials.

MDMs that include devices in their SBS stability studies often end up linking that particular device with the specific SBS used. They then feel it is necessary to repeat the stability study on the same SBS materials if a different device is packaged in it. This is not true. It is much better to keep SBS stability studies independent from any specific device.