Label validation

[Cliff]

I'm looking for a process for validating labels.

Has anyone validated the adhesive for labels? I'm not looking specifically for info related to the approved adhesive, but instead for how you validated it under different conditions?

For instance, storage at 2-6, on a rotator, in liquid nitrogen, in a -65 freezer...

What criteria did you use to determine the label remained adhered?

Thanks

[L106]

Ahhh......Gone are the days when you look through catalogues, pick out a label that appears to be suited for your need, buy them, use them, and if they didn't work to your satisfaction, you buy something different.

Life was so much simpler then......

[RR1]

Hi Cliff, it can't be a complex validation.Just list on a matrix what materials and temperatures you are going to test them by e.g

1.Label on glass tube-room temp

2.Label on glass tube- 37'c

3Label on glass tube 4'C

4.Label on plastic- room temp

5.Label on plastic- -40'C........etc...

and then on the top of the grid - what parameters you are looking at:

1. Smudeability

2.Staying in place after 48hrs

3. Staying in place when brought back to room temp

4. staying in placewhen centrifuged ...etc.

If you state how you want the label to perform first (your acceptance criteria), then just compare the result. The validation shouldn't really be more than 1-2 pages.

does this make sense?

[Cliff]

Rashmi,

Thank you very much.

How do you define "staying in place"?

Do you try to remove it?

How much force do you use to try to remove it?

[RR1]

You don't need to go to extreme lengths to try and remove- its normal use. Does the label come off when you touch it during usual use- or are the edges peeling away.

Do you want the label to come off cleanly- or doesn't this matter...in which case you don't need to test it.

It's the KISS technique...Keep It Short and Simple.

[Pat Distler]

There is a protocol in a very old FDA guideline. It's Appendix A (last few pages) in http://www.fda.gov/cber/gdlns/unilabel.pdf

This is rather extensive so you may not want to do this much. However, it's at least something to look at for ideas.