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Pharmaceutical Label Testing and Print Qualification

Polypropylene tubes, ampoules, syringes, vials, blister packs, and pouches are often used as primary packaging for pharmaceuticals (in direct contact with the product) that may require labeling. The secondary package (carton or container for the primary) might have an adhesive-coated, pre-printed label applied to its surface or printed directly. Labels must remain adhered, and print must remain legible and smudge-free after the distribution cycle and storage have been completed.

Several tests are available to evaluate and qualify labels and identification systems. A Sutherland Rub Test evaluates the scuff or rub resistance of printed or coated surfaces, paper, paperboard, films, and printed materials. In a Chemical Resistance Test, labels can be manually cleaned with IPA and peroxide wipes to determine if the label smudges, smears, or degrades in legibility. Peel Adhesion tests can be used to measure a pressure-sensitive label’s ability to remain adhered to the substrate.

For pharmaceuticals, the test objective may require qualification after exposure of samples to Temperature and Humidity, Conditioning, Accelerated Aging, or a 1-year Shelf Life upon reaching the expiration date.

Typical Procedures/Protocols

ASTM D6252
ASTM D5264
ASTM F1886
TAPPI T830

WESTPAK Capabilities

(1) Sutherland Rub Test machine
(1) Peel Test fixture
(9) Compression / Tensile Test Load Frames