Bioburden and Product Labels - VD Max studies on all the BOMs

[brandomenon]

Have you done testing on the labels to determine the upper limit of what they can handle for irradiation before there are negative effects on the product?

Too much and the colours can fade or they can even lose adhesive abilities. But if the product can handle a large dose, you have the possibility of dosing in multiple events. This allows you to send labels for irradiation, then perform VD Max study and have a second irradiation event to assure sterility of the labels.

This needs controlled conditions from the time the first irradiation happens so that you are not introducing more bioburden.

Another option would be to consider a second sterilizing method like steam or dry heat or ethylene oxide first, then run the VD Max study (and having irradiation as the second sterilization step in routine manufacturing) all depending on how the product holds up.

[Denis]

Thanks brandomenon

You've raised some good points, we have in the past "over" irradiated the labels in error, and the artwork is effected - and the material becomes quite brittle which is obviously something that we can't accept.

I hadn't thought of trying using other sterilizing methods, and this is something that I will look into.

The current supplier doesn't have to firm a grasp on what our requirements are, and I will work with them to ensure that they understand - but it may mean a change of supplier.