Verifying pharmaceutical products at the micron level

By Daphne Allen in Authentication on April 04, 2018

A technology used to authenticate products in the animal feed industry has inspired a potential solution for pharmaceutical packaging.

Micro-Tracers Inc. has offered analytical micro tracers used for quality assurance purposes in the animal feed industry since 1961. “These micro tracers have been formulated by Elanco (Eli Lilly), Zoetis (formerly Pfizer), and other major drug companies worldwide to identify their animal health products as proprietary,” Niti Kadakia, product manager for Micro-Tracers Inc., tells PMP News. Tracers are commonly known as taggants or physical chemical identifiers (PCIDs), which are typically embedded in or on products and packaging to identify them as proprietary.

Over the years, Micro-Tracers has developed many tracer variants. Perhaps the most novel of these tracer variants is SECURtracers, says Kadakia, explaining that they utilize technology from the semi-conductor industry for use in the pharmaceutical and nutraceutical industries to combat counterfeiting of proprietary products.

SECURtracers are small particles ranging in size from 50 to 200 microns that fluoresce under a UV light and have up to 10-12 letters or characters microengraved (10 or less microns in size) according to customer specifications, such as company name and/or a product or lot code.

The R&D team at Micro-Tracers, led by Dr. Nikolay Barashkov, is currently studying tracers etched with QR codes and bar codes to allow for digital tracking and tracing of the proprietary product anywhere in the supply chain, says Kadakia.

“SECURtracers are safe for human consumption as they are made entirely of food- and pharmaceutical-grade GRAS (generally recognized as safe) materials approved by FDA. The manufacturing process complies with FDA guidelines for use in solid dosage form drugs, powders, and coatings. They are chemically inert and non-digestible. In addition, SECURtracers have been designed for use on packaging and labels,” she explains.

The company has R&D in process with several printing partners on the use of tracers in printing inks for packaging and labels. Potential uses include UV‐curable inks applied to packaging and labels and use in blister packaging. “The tracers could go in a defined small area such as on the pharma company logo or as a strip across the packaging or on the label,” says Kadakia. “Since the tracers are covert, it will be necessary to identify an area where they are embedded for easy scanability and authentication of the package.”

Regarding embedding the tracers on blister packs, Kadakia says that because “SECURtracers are edible, they could go on the blister packs in a close proximity to the pills or capsules.”

In the field, inspectors would be able to use a very small and inexpensive kit to verify SECURtracers’ presence, the company reports. This allows on-the-spot field testing, providing positive, instant identification and verification of products.

Micro-Tracers is also working to apply the technology to tapes and transfer tapes, such as on the surface of commercially available security tape. In one trial, researchers used an adapter to turn an iPhone 4/4S into a digital microscope with 60‐100X power to read the SECURtracers particles. The built‐in LED light provides a bright, clear image for inspection. (An inexpensive 120x handheld microscope could also be used.)

Micro-Tracers will work with pharmaceutical companies to help define the use of tracers “whether it is on packaging, labels, or on the drug product itself,” Kadakia reports. “We work closely with our clients to best meet their needs. We will supply our tracers to their existing contract manufacturers or packagers/printers to embed these tracers on the packaging or labels based on design or best approach selected by the company.”


 
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