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Change in Medical Device Shipping Box - Transport Test Required?



Hi All,

Am turning to Elsmar once again for some quick answers.

We have conducted transport test on medical devices that were packaged in standard tyvek pouches and then in standard paper boxes (GC1) with particular dimensions. If I now increase the height of the box by about a cm, what would be the reasons to do a retest of the transport or not. Multiple of these boxes will be placed in containers that will then be padded with bubble wrap. Thanks again in advance for coming to my assistance.


Re: Change in shipping box - transport test required?

There is no gerneral requirement to do another transportvalidation for the packaging. I would like to see a risk analysis for the new packaging. There will be a good reason to change the height. So wirte it down, analyse influence on other aspects (e.g. loosening of inner tyvek pouch, ratteling effect) and than you re good.


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