Packaging-level authentication
Packaging-level authentication tools can be overt, covert, or forensic. Many experts recommend a multilevel approach, and
numerous suppliers offer an array of anticounterfeiting tools.
One company combines booklet labels with custom forensic markers that include digital tracking (SecurBook labels, ATL Security
Label Systems, Menomonee Falls, WI, using Nano-Molecular Markers technology from IDGLOBAL, Kelowna, Canada). To authenticate
product at virtually any time, the same forensic marker can be used on item-level labels, pedigree papers, and distribution
packaging. Other security products from this firm include single-ply labels with a forensic marker (SecurDetek), anticounterfeiting
holograms (SecurMark), three-tier overt or covert levels of anticounterfeiting (Triple-Ply), and destructible tape (PharmaVoid).
A camera-based technology photographs the unique natural microstructures of the package itself and stores the image for future
reference. This image also can be linked to other data such as date, product, and serialized codes. Because the digital signature
is based on the random characteristics of the material, it is virtually impossible to duplicate. A handheld reader–verifier
provides easy field authentication. In fact, the system could be set up to enable consumer verification through a cell-phone
camera (Biometric Authentication, Cortegra Group, Fairfield, NJ).
Cortegra also produces packaging with integrated anticounterfeiting technologies such as forensic markers; inks with ultraviolet-reactive,
color-shifting, or thermochromic properties; microprinting; holography; varnishes; threads; frangible papers; and digital
watermarks.
Digital watermarking incorporates machine-readable data into graphics or text so that they are invisible to the naked eye,
but detectable by a security-class reader with patented software. The hidden data are virtually impossible to duplicate so
if the original packaging is copied, the watermark will be missing from the copy (Digimarc Digital Watermarking, Complete
Inspection Systems, Indialantic, FL).
Anticounterfeiting features can sometimes be applied on the packaging line. A digital printer capable of overt or covert marking
runs as a standalone unit or can be mounted on the blister-packaging line. The system prints background information, identity
codes, sequential numbers, time and date stamps, and ultraviolet-visible colors in 1200-dots-per-inch resolution. It operates
at speeds as high as 20 m/min and handles four colors simultaneously. Digital printing technology allows each pack to be printed
with a randomly generated unique number that is 100% traceable to its time, date, and location of origin. Printing without
mechanical stretching protects the foil against microcracks that result from elongation. Printed information withstands heat,
pressure, abrasion, and solvent exposure (DTS 1200 blister printing unit, CSAT America, Louisville, CO).
Anticounterfeiting characteristics also can be imparted to blister foil during the production process. A patented technology
imprints fine-line graphics, text, logos, and microfeatures on the surface as the foil is rolled without affecting the material's
gauge, strength, or machinability. Virtually any aluminum gauge or alloy can be used, and the foil can be converted, lacquered,
laminated, coated, printed, and slit like conventional foil. The embedded images cannot be removed and are difficult to duplicate
because the high-precision laser technology used to create them is not readily available. In addition to child-resistant and
non-child-resistant blister foil, applications include cold-form foil, pouches, sachets, and induction seals for bottles (CPI
Security Foil, Constantia Hueck Foils, Wall, NJ).
Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Dr., Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, editorhal@cs.com
Reference
1. FDA, Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting
(Rockville, MD, July 2009),
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM171575.pdf, accessed Aug. 18, 2009.
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