How do I qualify a Label Design for Medical Device

[JuranCC]

21 CFR 820.120 states that "labels shall remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use”.
So I attach my labels to the medical device (in our case a Tyvek pouch then a second label on a Shelf Carton), subject the device samples to EtO, ISTA conditioning, Ageing & ASTM Transportion Testing ... just like I do with design verifcation devices ... but the how do I test my labels? Ok, legability can be inpsected visually, but how do I test that labels adhesion? I can't find any ASTM or any other standard which describes how to test the label to demonstrate that it is 'stuck' to the device packaging.
The label specs show that the adhesive has a min peel force and inital stick force of 500N .... will using these specs be enough to mitigate the risk or do I have to qualify the label adhesive when it is attached to our packaging design?
Any help would be great. Someone might have come across this before?
Thank You

 

[Gert Sorensen]

Re: How so I qualify a Label Design for Medical Device

You can demonstrate the adherence of your labels during your shelf life studies. They should adhere for the entire shelf life, and you already need to document that, so it is just an extra test point at the end of each phase. Initially you would of course have requirements that you have submitted to the supplier regarding your need for a certain adherence time.

 

[JuranCC]

Re: How so I qualify a Label Design for Medical Device

Is the adhesion just a test visual check, is there a performance test (peel, pull) which is used?

 

[MIREGMGR]

A visual test is sufficient. The requirement is that the label must "remain (...) affixed". There is no specification that a particular degree or quality of affixation be present.

 

[somashekar]

A visual test is sufficient. The requirement is that the label must "remain (...) affixed". There is no specification that a particular degree or quality of affixation be present.

Label material and fixing surface play an important role. This is to be considered during the design stage. Several reputed manufacturers (like 3M) offer various pressure sensitive adhesives (PSA) based on material and surface selection. It is also suggested that the label affixing area is kept as smooth as possible (comes for design) and clean and dry (comes from process) before affixing the label. If the label material is selected to be of some thickness, then a suitable cutout dipression made in the affixing area to the thickness of the label material locates the label correctly and helps in good adhesion as well as provides less chance for a forced removal. Rest of it can be checked successfully in the validation part of the device.