Abrasion Testing of Medical Labels

Reading Medical Labels

The information on the label of a medical bottle or device is just as important as what is actually in the item itself.  If the information is not readable or if it is damaged and misread, the medical or pharmaceutical product is useless for the individual or doctor, furthermore, it can be very dangerous and hazardous to the end user / patient.

“Printed and embossed information on packaging materials should be distinct and resistant to fading or erasing.”

The latest revision of the German coding rules from SecurPharm does have similar requirements in order to prevent falsified medicines.

“…for a print quality of at least 1.5 pursuant to ISO/IEC 15415 (see side table). The MAH, Has to take into account the wear and tear of printing.”

Abrasion Resistance of Printing

The abrasion resistance of the printing is not necessarily a question of the method of printing but more often depends on the substrate surface, the printing media (e.g. ink), and the parameters of the printing process itself.

In order to determine the best material and process parameters, an appropriate and reliable testing method is required. The IEC 68-2-70 “Abrasion of markings and letterings caused by rubbing of fingers and hands” describes an ideal method for testing the packaging materials of the medical market.

IDT Biologika GmbH in Germany together with Tribotron has developed internal standards to test printing and packaging according to the IEC 68-2-70, ensuring compliance with the latest GMP and SecurPharm standards.

Hand Abrasion Test According to IEC 68-2-70

This standard describes a method of testing applicable to markings and lettering on flat or curved surfaces, which in service are subjected to rubbing forces caused by the fingers or other parts of the hand.

Hand abrasion is a very complex chemical and mechanical stress on the surface. The TRIBOTOUCH instrument simulates this stress under real conditions according to international standards. Furthermore, the versatile setup of the TRIBOTOUCH allows users to reproduce specific chemical environments by adding artificial sweat, hand cream, or antiseptic fluid.

Testing of the Labels

For verification purposes, IDT Biologika has produced special labels. The labels have been tested with the standard setup according to IEC. In the following case the printing quality was not sufficient to meet specifications. Even though many medical products may never experience physical touching 30 times, the packaging is exposed to abrasion in the manufacturing and transportation processes so some security tolerance shall be implemented.

Summary

In order to assure that patients are receiving the best pharmaceuticals and medical devices, the same care and attention to detail that is devoted to the manufacturing of the items should be also be given to the labeling of those items.  The TRIBOTOUCH is an ideal instrument to test the abrasion resistance of packaging and labels of medical products. It can be used for design verification, for definition of printing parameters, and for continuous quality control of the manufacturing process. The TRIBOTOUCH features real life testing on finished products or lab samples.

The TRIBOTOUCH is qualified in the medical market and for use in this application.