New Systems for Counterfeit Protection and Quality Control - Pharmaceutical Technology

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New Systems for Counterfeit Protection and Quality Control
Counterfeiting prevention has joined quality control as a top concern for pharmaceutical manufacturers. Both issues received a high level of attention at the recent Interphex and Interpack trade exhibitions.


Pharmaceutical Technology
Volume 6, Issue 29

Product security and quality control were major themes of this year's Interphex trade show, held April 26–28 in New York City. A variety of interesting packaging machinery innovations were featured at the event.


Hallie Forcinio
Brand protection
Counterfeiting and diversion have become top concerns for pharmaceutical manufacturers as counterfeiting technology becomes more sophisticated, the incidence of fake products increases, and organized crime and terrorists turn to counterfeit goods to generate cash flow. Most experts recommend layering protective technologies by selecting a combination of overt and covert techniques. To provide track-and-trace capability, especially for Class II drugs, some drug manufacturers have begun to include radio frequency identification (RFID) tags at the item level.

Overt technologies are readily visible and include features such as holograms or color-shifting ink. Covert technologies are not visible to the naked eye and include the use of security markers, or taggants, which can be mixed with inks, coatings, or the packaging material.

One taggant solution consists of using particles half the diameter of a human hair to create a code that is revealed by a special microimaging reader and software. These taggants can be made from food-grade materials such as cellulose or gelatin and can be incorporated into the packaging in various ways, such as:
  • an adhesive;
  • a coating on a label or other packaging substrate;
  • a stripe on the side of the cap;
  • in combination with a desiccant.

The taggant can be customized to create a unique signature for the product. Authentication can occur on three levels, including simple presence detection with an off-the-shelf scope, pattern matching of the cell-like taggant with a camera-based system, and the removal of the taggant to confirm its identity (Invisible Security Marker, Adhesives Research, Inc., Glen Rock, PA, http://www.adhesivesresearch.com/) Invisible Security Marker Micro-Imaging Reader, Complete Inspection Systems, Inc., Indiatlantic, FL, http://www.completeinspectionsystems.com/).


Label Vision Systems off-line configuration accommodates random sampling typically used to check incoming supplies. An in-line configuration mounts the bar code print verification system on the printing press or at the rewind.
Another taggant supplier can create an almost infinite variety of unique codes by mixing odorless, colorless taggant powder in ink or other media in quantities of less than two parts per million. This low concentration means that it is nearly impossible to find, much less reverse-engineer, the taggant. The randomly dispersed taggants create a unique fingerprint that is readable by a proprietary electromagnetic reader. The fingerprint is identified by reading a specific area on the package or label such as a logo. By using an electronic grid, the reader measures and assigns positions to 12–15 particles in the field of view using an edge detection algorithm. Then, this information is stored in 16–20-bit encrypted code thereby requiring minimal data storage. Plug-and-play software is provided, allowing brand owners to establish and maintain their own databases. The software can be standalone or a bolt-on module for an enterprise resource planning system. Readers can be simple pass–fail devices or decoders and can be disguised as an everyday object such as a cell phone or pen. The process of compounding the taggants with the drug ingredients, or applying a taggant-equipped coating to solid dosage forms, is being studied in conjunction with the US Food and Drug Administration. Such methods would provide product authentication at the pill level (Creo Traceless Security and Authentication System, Creo, Inc., Burnaby, BC, Canada, http://www.creo.com/traceless).


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