Hi,

We have a device that is sterilized and packaged with a Sterile Barrier System (SBS), and labelled with a use by date, up until which time the device is guaranteed to remain sterile.

To validate the sterility Use By Date, is it acceptable to provide evidence after real time and accelerated aging of the packaging alone, or do we have to perform tests on the packaging while containing the device?

Any opinions are much appreciated.
thanks
Simon

Hi,

We have a device that is sterilized and packaged with a Sterile Barrier System (SBS), and labelled with a use by date, up until which time the device is guaranteed to remain sterile.

To validate the sterility Use By Date, is it acceptable to provide evidence after real time and accelerated aging of the packaging alone, or do we have to perform tests on the packaging while containing the device?

Any opinions are much appreciated.
thanks
Simon

You need to use samples containing the medical device to demonstrate that the sterile barrier will keep on being sufficient for the entire lifetime of the product. If the product could in any way influence the packaging then the package should contain products. IMHO

From my past experience with packaging integrity my recommendation is to ship your products under the most extreme conditions (temperature and humidity) to a location (far away) that you ship regular products to. Have your products returned to your company and use these as well in your real time and/or accelerated testing. Don't underestimate the impact that transportation can have on your packaging.

Regards,

Rob.

You do not need to include the product in the package if you can rationalize that the product does not interact with the packaging during aging. If you read the note after 6.4.4 in the 11607:2006 standard it states that performance testing and stability testing are seperate entities.

You do not need to include the product in the package if you can rationalize that the product does not interact with the packaging during aging. If you read the note after 6.4.4 in the 11607:2006 standard it states that performance testing and stability testing are seperate entities.

I will still argue that the product can, and often will, have influence on the packaging. I believe, that one should be very careful excluding the product when testing packaging.

I agree with Gert, the product should be included in the packaging. You should also check that the product itself is unaffected by aging. Don't forget to sterilise the product/packaging before starting the aging process.