Hello Summer,
It has been a while since I worked specifically with packaging materials, but I remember there were some label adhesion tests. These were not specific to blood bags, these label adhesion tests were for different types of glues used in labels and attachments to different surfaces like plastics or metal. As an example, there is an ASTM adhesion peel test and ISO 8510 series which could be used - again not specific to blood bags - though you could most likely write a protocol addressing the type of label you have (size), the adhesive being used, surface attachment (the blood bag), and environmental conditions exposed to maintain adhesion of the label (freezing temperatures). You most likely would have to develop your own testing method as I am not aware of a specific label adhesion test for blood bags, but the other test methodologies could be adapted specific to your needs - just mean your organisation might need to invest in doing these tests. Unless there has already been some testing done by either the label manufacturer or adhesive manufacturer who could provide information.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 22-Oct-2020 13:37
From: Summer Young
Subject: Adhesives for the labels applied directly on the blood bags
Dear RAPs members,
Does any one know what is the requirement for the adhesives on the back of the labels that directly applied on the blood bags?
I found one documents that FDA issued in 1985 saying the adhesives in compliance with 21 CFR 175.105 can be applied on the base label of the blood bag, and also saying there are additional requirements for the adhesives directly applied on the blood bags but did not specify what additional requirements.
I cannot find any other documents on this topic. Any information would be highly appreciated!
Summer
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Summer Young
USA
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