Label Shelf Life shorter than Product Shelf Life

[Quality Priest]

Just wondering if I am over complicating things here.

Our product range has a 3 year shelf life which we have justified to our regulatory authority.

As part of our continues improvements we have changed the packaging labelling on our product range.
The label supplier states that their label has a two year shelf life.
Do I take the shelf life of their label as our lowest expiry date and therefore need to change our product range shelf life accordingly?
Just wondering how other people have got round this?

My current plan is to perform accelerated aging of several products with labels and to use my findings as justification for our shelf life but if anyone has an easier solution ???:

 

[David Hartman]

Re: Label Shelf Life

If the label you're speaking of is used as intended by the manufacturer by sticking it to your product packaging, then its "shelf life" is no longer applicable (it is no longer in storage, but is in use).

For clarification, "shelf life" is a term given for materials that have set in an un-used condition for a period of time (e.g. batteries setting on a shelf), but once in use the shelf life no longer applies. Some items will actually last longer once in use, others no as long.

 

[Bev D]

that said, if the label will actually fall off or fade away in 2 years then my action would be to get a better label...

 

[David Hartman]

that said, if the label will actually fall off or fade away in 2 years then my action would be to get a better label...

Absolutely.

You also should understand that a manufacturer's "shelf life" statement is basically a guarantee/warranty statement that their product will be usable up to the end of that period. What I have found in a past life, is that some manufacturers of limited life materials (dependent upon what the material is) will tell you that if the product still functions as it should then you can probably use it, but they will not warranty its acceptability beyond the stated timeframe.

As an example I have maintained gallon containers of silicon-based thermal compound in storage. One manufacturer claimed no shelf life for this material, another claimed a 5-year shelf life. When questioned the manufacturer with the 5-year shelf life stated that as long as the material in the container was thoroughly stirred every 5 years, it could be maintained for an additional 5 years (ad infinitum).

 

[Quality Priest]

Thanks for the comments, and yes the `Will the labels fall off in two years` was part of my original concern.

Having spoke further with other test houses and a little research on the net.
The company supplying the labels is only interested in the labels up to the point of use and by stating a two year shelf life they are covering the standard requirements for packaging labels.
There are no standardized protocols for qualifying packaging labels after the point of use.

Luckily our product range is a fast moving one so no product should see the end of its shelf life.

Current plan is to hold samples for the life of the product and test the labels at varying stages.

Thanks

 

[Statistical Steven]

Part of your stability testing program should include how the label behaves up to 3 years. Usually a stability program has requirements for labeling, sterility, device performance, aesthetics and other quality characteristics. If the label still performs after 2 years then it is considered acceptable regardless of the claim from the manufacturer.

Thanks for the comments, and yes the `Will the labels fall off in two years` was part of my original concern.

Having spoke further with other test houses and a little research on the net.
The company supplying the labels is only interested in the labels up to the point of use and by stating a two year shelf life they are covering the standard requirements for packaging labels.
There are no standardized protocols for qualifying packaging labels after the point of use.

Luckily our product range is a fast moving one so no product should see the end of its shelf life.

Current plan is to hold samples for the life of the product and test the labels at varying stages.

Thanks

 

[chiragtilara]

I agree with Steve's comments. You should be evaluating full device including packaging and labelling for shelf-life.