Tablets & Capsules

TC0118

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6 January 2018 Tablets & Capsules Laser marking UV laser marking of pharmaceuticals has been tested and adopted in the USA and around the world. It applies perma- nent, non-damaging marking that helps identify, track, and trace drug products from the manufacturer to the patient. UV laser exposure darkens a surface without degrading it. The darkening is caused by irreversible phase transitions in titanium dioxide, an FDA-approved color additive used as a whitening pig- ment in many formulations. The mark- i n g s p r o d u c e d a r e c h e m i c a l l y extremely stable and mechanically inerasable. The process does not require any surface and/or print condi- tioning before or after marking. clarification The October 2017 article "The evolution of on-dose product identi- fication," by Edward S. Novit, incor- rectly referred to one method of placing identifiers on tablets and cap- sules as "laser engraving." The correct term is ultraviolet (UV) laser mark- ing, which is a method of placing detailed, high-definition information on pharmaceutical tablets and cap- sules without damaging their surface or compromising or contaminating the underlying medication. Tri-Star Technologies, El Segundo, CA, introduced UV laser marking of p h a r m a c e u t i c a l s i n 1 9 9 9 . I g o r Murokh, PhD, the company's senior scientist, provided the following information and images. Figure 1 shows a 0.7-millimeter- thick soft gelatin film similar in struc- ture and composition to what is used in the pharmaceutical industry. A data matrix code measuring 4 by 4 millimeters is marked on its surface, which was doped with titanium diox- ide. There is no visible deformation, and the mark is evenly distributed in a thin "under-skin" layer that is impossible to remove or alter without damaging the surface. Any attempt to do so would be easy to detect. Figure 2, at the same magnifica- tions, illustrates the very shallow penetration of the mark. It hardly penetrates the film and is far from the opposite side, meaning it never contacts the active pharmaceutical ingredient. Figure 1 A data matrix bar code on the surface of a soft gelatin strip at different magnifications 1 mm 0.5 mm 0.2 mm Figure 2 Cross-section of the surface of the marked soft gelatin at different magnifications 1 mm 0.5 mm 0.2 mm www.t a b l e t s c a p s u l e s .com

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