Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published PMPN September 2005
TrackandTrace
Blending In
By Daphne Allen, Editor
Adding tiny particles to packaging substrates or printing inks has distinct track-and-trace benefits. The particles can be customized and assigned to specific users and products, creating unique signatures that can be authenticated manually or automatically. Their use may not add an extra step to packaging lines, as the particles can be added to plastics, films, papers, inks, or other raw materials by material providers or converters. These particles can be changed as often as needed, and sometimes they can be serialized, giving users flexibility and unit traceability.
Most importantly, they can be used covertly, keeping a solution under wraps. Says Kevin Harrell, director, global business development, for Creo Inc., a subsidiary of Kodak (Burnaby, BC, Canada): “Industry is shifting to covert technologies. The overt ones are being copied.” Harrell spoke during the EastPack 2005 show in New York City in June.
So why not add these particles to your packages? They can increase package costs, given the material and effort it takes processors and converters to provide customized materials. Users must also be equipped to verify and record particle presence, especially when serializing packages. The investment, however, may be worth it for pharmaceuticals and medical devices facing the most risk of product counterfeiting.
TAGGANTS
These microscopic particles are often known as taggants. One provider, Microtrace LLC (Minneapolis), has been offering its Microtaggant Identification Particles for more than 20 years, after acquiring the technology from 3M. The microscopic plastic taggants consist of multiple colors and layers that represent unique numeric codes. Recent advances in the technology incorporate multiple energy-sensitive nanotaggants into the structure of the Microtaggant.
Microtrace provides these taggants in compounded plastic resins or in coded transfer tape for application to films. The firm also works with film converters to extrude these taggants directly into films or to coat films with taggants in the PSA layer; it works with paper manufacturers to add the taggants to pulp. The taggants can also be mixed with adhesives or ink, or provided in bulk. Microtrace registers each Microtaggant code in a central database and does not duplicate the codes for any other user. Taggant presence can be identified microscopically or with handheld readers in the field.
Creo offers a taggant powder that is inert and tightly controlled. Made of an undisclosed material, the Traceless taggants can be mixed into paper pulp, ink, varnish, laser toner, spray powders, plastics, and even metals. The powder can also be applied in unique patterns that can be recorded numerically with an encrypted algorithm and stored in a secure database. Proprietary readers from Creo can indicate taggant presence and read taggant patterns, depending on the level of security implemented.
There is some debate over the appropriate particle size for covert systems. Creo’s powder taggants need only a tiny amount—less than two parts per million (ppm)—for detection. “This low concentration means that it is nearly impossible to find, much less reverse-engineer, using even the most advanced forensic analysis methods such as inductively coupled plasma mass spectrometry,” reads a press release from Creo. Adds Harrell: “Taggants above 10 parts per million are being discovered through analysis by counterfeiters,” he says. “It is critically important to remain below 10.”
Brogger from Microtrace explains that Microtaggants are visible to the unaided eye, but just barely. But while the particle size could be considered large in comparison to Creo’s, for instance, Microtaggants feature multiple layers of security within each individual particle. The colored layers, for instance, could be formulated with additional taggant powders that are able to provide unique spectral or infrared signatures. So even if a counterfeiter could duplicate the look of a Microtaggant, thorough analysis would be needed for complete authentication. The highest level of security with the Microtaggant provides a unique identification for each individual item that cannot be replicated.
MARKERS OR TRACERS
Markers or tracers are another type of covert particle that can be added for secure authentication. For instance, Authentix (Dallas) offers a range of markers in both organic and inorganic forms. Its Quantum Photonic Markers, which range in size from 10 nanometers to 1 micrometer, can be added to inks and coatings or placed on most packaging materials. They can be detected when exposed to very specific wavelengths of light.
Molecular markers range in size between 1 to 10 nanometers. Many of these are simple organic compounds that FDA has deemed safe or generally regarded as safe (GRAS), some of which are made from substances listed in the Center for Drug Evaluation and Research inactive-ingredient guide, explains Jim Rittenburg, PhD, vice president of pharmaceuticals, Authentix. Because of this, some types of these markers are ingestible and therefore can be added to the product itself.
Authentix also offers mass-differentiated markers, which can range from one to ten nanometers in size. According to Rittenburg, Authentix takes a compound and adds neutrons, which changes the compound’s molecular weight by making the compounds heavier. “It’s a security feature that’s detected by proprietary lab analysis. This lab analysis is evidence that will stand up in court if the need arises,” he says.
At EastPack, Ampacet Corp. (Tarrytown, NY) introduced AmpaTrace molecular tracers that can add distinguishing elements to plastic packaging. The tracers are chemical compounds that, when used at 100 ppm, can be analyzed using standard lab equipment.
The compounds themselves are metal salts which come from a range of materials with unique signatures, says Rich Novomesky, market manager for Ampacet. Adding these to plastics is no easy feat, as the residue of catalysts from plastic manufacturing can interfere with the tracers, “so you need to be sophisticated,” he says.
With that challenge in mind, Ampacet will add the tracers to color or additive masterbatches and provide them to injection or blow molders, extruders, or other plastics processors. It can vary the type, proportion, and concentration of the tracers, as needed. When adding them to custom colors, Ampacet will make the necessary adjustments for color matching.
Novomesky calls the tracers a “very economical solution” when compared to taggants. In addition, “you can change the tracer as often as necessary,” he says.
BEYOND THE TAGGANT
This year, both Microtrace and Creo have announced partnerships with ink manufacturers to offer security ink. Microtrace has teamed with XSYS Print Solutions (Stuttgart, Germany) to add Microtaggants to inks in UV-curable formulations for flexographic or screen printing. (XSYS Print Solutions has just agreed to merge with Flint Ink Corp. [Ann Arbor, MI].)“Adding taggants to flexographic printing operations has been a challenge because of the large particle size,” explains Brian Brogger, vice president of Microtrace. “It has been hard to transfer large particles successfully, but we have worked with XSYS to develop a formulation and technique that works.” The inks are formulated exclusively for each customer or application.
According to Brogger, printing with taggant-enabled ink may give users more flexibility. “You can make changes on the fly, since you aren’t dealing with changes that may affect molding volumes.”
Creo is working with Xink Laboratories (Ottawa, ON, Canada) to add its taggant powders to ink for printing radio-frequency identification (RFID) antennas. The taggant powders in the ink can be read on high-speed lines by machines supplied by Creo that capture images of the taggant patterns. The readers then transmit these images to Creo’s taggant image signature software system, which assigns encrypted identification numbers to each antenna and archives those numbers. Creo says that coupling the new flexographic ink formulation with its software will enable RFID tag users to verify the authenticity of the tags themselves.
Creo is also working with Acucote Inc. (Graham, NC) to produce security label printing stocks. Creo’s Traceless Taggants will be embedded in Acucote’s pressure-sensitive label stocks. Acucote will then offer these stocks to label converters. Lynn Crutchfield, executive vice president of Acucote, envisions “customs agents using Creo readers to find authentic labels produced from Acucote’s materials.”
Using covert taggants in printed packaging components is a popular and effective solution, says Kregg Albrecht, director of solutions engineering for Nosco Inc. (Gurnee, IL). “Like any good security technology, taggants are easy to verify and hard to duplicate. Taggants are typically added to inks, coatings, or laminates and are well suited for processes for printing labels and cartons. Sometimes the taggant is the only security feature, but more commonly it complements a second or perhaps even a third security feature, forming a layered solution.” He says one common technique emerging as a “leading means for brand protection is layering an optically variable overt feature with a covert taggant allowing for both consumer and forensic authentication.”
Nosco uses taggants from Creo and Inksure (Fort Lauderdale, FL). James Assaf, CEO of U.S. operations for Inksure, says that the application dictates taggant material choice. “We use a combination of materials and readers that work with different light sources and at different wavelengths. Our suggestion is based on the substrate used and the security needed.”
Layering different coding solutions is another tactic. Microtrace is working with laser system manufacturer Photoscribe Technologies to promote use of both technologies. “Laser marking in conjunction with the Microtaggant provides a powerful multi-level approach to brand protection,” says Brogger. “The small markings made by the Photoscribe laser systems cannot be seen or located by the unaided human eye.” Microtrace can also deliver laser-markable compounded plastic resins in which a color change occurs where the laser beam images these compounds. For the highest level of security, the Microtaggant Identification Particles can be compounded into the laser markable resins and both capabilities can be delivered in a single master-batch.
Ampacet’s Novomesky also supports the use of multiple technologies. “Manufacturers can apply AmpaTrace identifiers alone or as part of a multi-level traceability system in conjunction with bar codes, digital tags, product taggants, and other elements.”
The important thing, says Assaf from Inksure, is to use a covert machine-readable technology that is compatible with overt counterfeiting solutions. The overt solutions could be verified by many parties in the supply chain, whereas the covert solutions are custom codes that can be used as “field forensics,” he says.
CHOOSING THE BLEND
Taggants, markers, and tracers give packagers a lot of options and flexibility, given their ability to blend in with almost any substrate. But their use turns an off-the-shelf material or masterbatch into a custom request. Manufacturers may therefore need to turn high-volume stock orders into just-in-time custom requests. This conversion itself presents its own challenges, which can involve warehousing and logistics needs as well as inspection and archiving responsibilities. Sophisticated infrastructure may be needed to support such custom solutions.
Albrecht of Nosco says that his company helps clients compare and contrast the benefits of various authenti- cation technologies. “It can be a challenging task with new options emerging on a consistent basis. We educate our clients on a variety of technologies, but ultimately we collaborate with them to define the problem and then fit the appropriate solution to meet their goals. Throughout this process, we find that taggants are frequently a preferred solution either by themselves or layered and rotated with other options.”
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