Since 1961, Micro-Tracers, Inc. has been devoted to manufacturing tracers used for quality assurance purposes by the animal feed industry. The microtracers have been formulated by Elanco (Eli Lilly), Zoetis (formerly Pfizer), and other major drug companies worldwide to identify their products as proprietary.
Micro-Tracers is part of a group including Anresco, Inc., a commercial analytical laboratory providing analytical, consulting, and research services, primarily to the food industry. Micro-Tracers has now added to its product offering a novel, covert, edible, on-dose authentication solution for the pharmaceutical and nutraceutical industry- namely, SECURtracers. The product was initially developed as an on-dose authentication solution for solid dosage form drugs, but it has since evolved to have applications on packaging and labeling, and it can be used for authentication of products throughout the supply chain and across industries.
SECURtracers allow verification of a drug product ‘on-the-spot’ at the dose level, even when separated from the original packaging providing added brand protection and patient safety. Additionally, SECURtracers belong to a class of anti-counterfeiting technology known as Physical Chemical Identifiers or PCIDS, as defined by the FDA. In 2011, FDA published a second set of guidelines detailing the incorporation of PCIDS in solid oral-dosage form drugs. SECURtracers meets all outlined criteria.
Uniquely, SECURtracers specifically addresses the problem of counterfeiting, product recall and return monitoring, product diversion, and quality control in the pharmaceutical and nutraceutical industry. SECURtracers helps reduce liabilities, prevents loss of revenue, and provides brand protection.
SECURtracers are manufactured using plasma etching technology widely used in the semi-conductor industry. The adaptation of this technology for manufacturing of these food- and pharmaceutical-grade PCIDS is not simple. It requires a team of chemists and chemical engineers with diverse education, experience and skills, making these tracers impossible to duplicate.
What sets SECURtracers apart from other tracers is that they are made entirely of food- and pharmaceutical-grade GRAS (generally recognized as safe) materials by FDA. Particles 50-200 microns in size are micro-engraved with lettering of 10 or less microns in size. Engraving can include almost any letter, number or symbol.
Another big differentiator is that SECURtracers are very easy to identify and inexpensive to authenticate proprietary products. Counterfeiting drugs is a highly profitable crime in revenue generating between $75 billion and $200 billion a year. The WHO estimates 1 million people die every year from counterfeit drugs. 15% of medicines in circulation worldwide may be fake. In Asia, Africa and Latin America fake medicines may account for up to 30%.
To prevent this and to ensure safety for everyone who uses them, SECURtracers can be instantly identified as fluorescent gold specks under a UV flashlight. The product can be further authenticated by viewing the micro-engraved lettering under an inexpensive handheld microscope. The entire process can take less than three minutes.
To identify tracers embedded on pills and capsules, a simple magnetic separation device and procedure needs to be employed. The separation kit is provided by Micro-Tracers at a nominal cost compared to many other readers that can cost a few thousand US dollars.
Micro-Tracers is attempting to bring the paradigm of a simple ‘on the spot’ test it has popularized in the formula feed industry to the pharmaceutical industry to fight the global challenge of counterfeit drugs. With SECURtracers you can “Authenticate with Confidence” – says David Eisenberg, President at Micro-Tracers, Inc.
Overall, this unique product offers the pharmaceutical industry with a range of opportunities, and moving forward Micro-Tracers will be seeking to continue to adapt and develop this innovative solution to ensure that it continues to meet its clients’ needs.