Hi folks,

We have a client that feels they need to do some validation work with the labels they use. They purchase label stock with some pre-printed information and then print additional information (lot number, etc.) immediately prior to application on a plastic vial (read "medical product"). The vials contain an alcohol solution so we have verified the labels maintain integrity when exposed to (actually soaked in) the solution for over an hour.

They have had some instances of labels peeling off unexpectedly - potentially due to exposure to cold (that's not been confirmed). In any case, these vials will be transported over land / air so they will be exposed to a wide range of temperature, humidity, and pressure.

We're struggling with the bounds of the validation effort. UL 969 appears a good candidate for guidelines. Can anyone suggest alternatives, maybe more suitable to medical? Can anyone suggest additional validation tests? Thanks.

Had a similar situation where the peel off labels were not staying put over time. It was determined that the method of removal from the sheet affected the integrity of the label, i.e., it curled. If the label was peeled off the sheet, it developed a memory that would cause the label to return to the curled condition it had when it was peeled from the sheet. Whereas if the sheet was peeled from the label the lable did not curl and as a result the labels stayed on the item without falling off. This could be the case, trynit and see.

A couple of things to look at. What stock are they printed on? What type of Pressure sensitive adhesive is on the back? What type of plastic for the container? What is the surface tension of that particular plastic...below 38 dynes/cm2 it needs some sort of pretreat.

Welcome to The Cove, Yodon! :bigwave:

On the interesting subject of test design for label adhesion I went to Google and found the following:

http://www.loc.gov/preserv/supply/specs/700-703.html

From ASTM International ( http://www.astm.org/cgi-bin/SoftCart.exe/STORE/standardsearch.shtml?L+mystore+vrxu3730+1165082744 ) and the key words "test label adhesion" I got this list. http://www.astm.org/verity_hist.cgi?UserQuery=TEST+AND+LABEL+AND+ADHESION&SEARCH_COLLECTION=ACTIVE_REDLINE&SEARCH_STATUS=ALL&x=16&y=8&MARKETING_CODE=GP1&NS-search-type=Free+text&NS-max-records=5&NS-search-type=boolean&NS-query=TEST+AND+LABEL+AND+ADHESION+AND+NOT+%28STATUS+%3CNEAR%2F1%3E+REPLACED%29&CART_NAME=vrxu3730&STORE_NAME=mystore&NS-collection=ASTM_ACTIVE_REDLINE&NS-collection2=ASTM_HISTORICAL&NS-collection3=ASTM_WITHDRAWN&NS-collection4=ASTM_WORKITEMS

They are downloadable publications for sale.

I hope this helps!