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).
Glued construction and strategically placed diecuts and tear strip impart child resistance to a wallet pack from Carton Service-Packaging
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).
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).
A handheld reader from Complete Inspection Systems or a cell phone can authenticate product by capturing an image of an otherwise
invisible digital watermark.
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).
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).
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).
The ISTAR system from Pharmorx relies on a highly magnified image to authenticate product at the pill level.
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).