Hi, I don't know if this is the right spot in the Cove, but I am sure that the thread will be moved if it should have been posted elsewhere. :D

Has anybody got any experiences regarding how to test cardboard material and peelpack material during transport and ETO-sterilization. How does one go about it easily if one wants to incorporate temperature and rH in a structured manner?

Ideas and input would be greatly appreciated :thanx:

Temptales, Dataloggers are available that can be used to monitor during the shipping studies.

Temptales, Dataloggers are available that can be used to monitor during the shipping studies.

Thanks!

As usual, I'm not so clear in my phrasing.... I was thinking more along the lines of how to incorporate: Cold, heat, low humidity, high humidity, and the extremes of EtO-sterilization..... Any ideas?

Thanks!

As usual, I'm not so clear in my phrasing.... I was thinking more along the lines of how to incorporate: Cold, heat, low humidity, high humidity, and the extremes of EtO-sterilization..... Any ideas?

So are you looking for ETO validation or shipping studies during transportation ?

Hi, I would also consider transportation methods from your plant to the end customer. Even take care of transport by plane. It may impact your packaging integrity. My advice would be to setup a test by shipping goods around the world under worst case conditions and test both packaging and product performance afterwards.

In real life transportation you can not always control temperature and humidity, or you won't case of the additional costs.

Rob Udo

So are you looking for ETO validation or shipping studies during transportation ?

I'm looking into "how can we monitor and control what happens to our packaging from the moment it leaves our plant till it has been sterilized and returned, shipped by lorry without insulation. And what impact will this have on our packaging for the lifetime of the device (6 years)??"

I'm looking into "how can we monitor and control what happens to our packaging from the moment it leaves our plant till it has been sterilized and returned, shipped by lorry without insulation. And what impact will this have on our packaging for the lifetime of the device (6 years)??"

Gert,

Pls note that there is one ISO 11607 to address the packaging issues (combining EN 868 - 1 standard, Part I of II). Refer to http://www.iso.ch/iso/en/CatalogueDetailPage.CatalogueDetail?CSNUMBER=38713&scopelist=ALL

The International Standards Organization (ISO) 11607 standard is the foremost guidance document for validating packaging for terminally sterilized medical devices. Packaging must comply with ISO 11607 to ensure that the enclosed medical device is kept sterile throughout manufacturing, shipping, and storage environments.

Test methods also have to be incorporated from ISO 11607 validated test methods. You can refer to this site for very informative videos on different test methods - http://www.testedandproven.com/ISO11607.html

I am assuming your product is medical devices. Speaking from the sterilization perspective, your product design / development, sterilization cycle validation, and planning for product realization activities should address packaging requirements that are suitable to the lifetime of each device class.