To Protect and Package - Pharmaceutical Technology

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To Protect and Package
Products at INTERPHEX focused on protection, compliance, and deterring counterfeiting. This article contains bonus online-exclusive material.

Pharmaceutical Technology
Volume 33, Issue 5

Anticounterfeiting tools

Glued construction and strategically placed diecuts and tear strip impart child resistance to a wallet pack from Carton Service-Packaging Insights.
A new anticounterfeiting technology is an encryption machine that is inserted into the production line and makes nanoscale changes on the surface of a solid dosage form. Pill-level encryption makes it possible to nondestructively authenticate pills anywhere in the supply chain, even if no packaging is present. The process doesn't add anything to the pill or change its dissolution or other characteristics. Three levels of protection include semi-overt, covert, and forensic. For those who know what to look for, semi-overt changes are visible to the eye. Covert changes are at the micrometer scale and can be customized per dose, per drug, or per manufacturer. They are read with a handheld loupe or 20 power microscope. The forensic level is a nano code that can carry large amounts of information such as batch identification, manufacturing date and location, distribution country, and the serialized information from two-dimensional or traditional barcodes. Decoding requires proprietary equipment and software. The codes are so small that it's possible to fit 350 in the width of a human hair. Commercial products featuring this encryption are expected by the end of 2009 (NanoEncryption technology, NanoGuardian, Skokie, IL).

Another pill-level anticounterfeiting tool relies on high-magnification imaging to capture a picture of each dose as it is blister packed. Each image is stored in a database and linked to the serialized code on the primary package. To authenticate product, a proprietary algorithm compares regions of interest on the tablet with images in the database. When a match is found, users can quickly locate its history by linking to a pedigree database (ISTAR image storage, tracking, and recognition, Phar-morx Security, Framingham, MA).

A handheld reader from Complete Inspection Systems or a cell phone can authenticate product by capturing an image of an otherwise invisible digital watermark.
Similar technology relies on the fact that each punch-die set used in a tablet press imprints its unique fingerprint onto every pill. An ordinary flat-bed scanner or digital camera takes a photo of the punch die surface and stores it in a database on a secure server. To authenticate a pill, an image of its surface is captured by a scanner or camera and compared to the stored punch-die images. A match confirms product authenticity (Fingerprint technology, AlpVision, Vevey, Switzerland).

Digital watermarking provides a covert way to authenticate packaging. It incorporates machine-readable data into graphics or text so that they are invisible to the eye, but detectable by a security-class reader loaded with patented software. The hidden data are virtually impossible to duplicate so if original packaging is copied, the watermark will be missing from the copy (Digimarc Digital Watermarking, Complete Inspection Systems, Indialantic, FL).

Quality assurance

Proofreading systems' ability to help prevent errors in printed packaging and labeling continue to expand. Several systems can not only compare hard copies, but also compare electronic files to hard copies and electronic files to electronic files to accommodate an increasingly digital package and labeling design and production process. Some large, multipage documents (up to 12 34 in.) can be proofread in a single scan (AutoProof Pro Proofreading Suite 3.5, Complete Inspection Systems).

The ISTAR system from Pharmorx relies on a highly magnified image to authenticate product at the pill level.
For large-scale users, a client-server configuration lowers information-technology costs and makes it possible to update proofreading software from a server rather than installing it on each individual workstation. Set for release before the end of 2009, the format-independent software permits the comparison of unlike files and the simultaneous examination of multiple master documents even if different languages are involved (Docu-Proof R2, Global Vision, Montreal). Other software tools group, number, and classify the differences detected between electronic files or hard copies and flag variations in color (Digital-Page 5.0, Scan-TVS 5.0, Global Vision). Also new is a Braille inspection solution that detects changes as small as 0.1 mm in the height of the embossed or glue dots that form Braille codes (BraillePoint, Global Vision).

Another proofreading system offers a color-matching function based on the Pantone color system widely used by printers. It also can be configured to work with a corporate color standard (Avia Color Matching Module, Mnemonics, Mount Laurel, NJ). In addition, a color-inspection option has been added to counterfeit-detection software that not only authenticates product, but can export images for use in legal documents (Avia Private Eye Anti-Counterfeiting Module, Mnemonics).


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