Pill-Level Product Protection - Pharmaceutical Technology

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Pill-Level Product Protection
Authenticating tools help identify counterfeit drug products. This article contains bonus online-exclusive material.


Pharmaceutical Technology
Volume 33, Issue 9

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,

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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