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.
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,
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,
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.