Telling Time (and Temperature)

New smart inks can provide immediate evidence of whether a temperature-sensitive pharmaceutical product has been diverted or mishandled.

By Daphne Allen
Editor

The mishandling or diversion of temperature-sensitive pharmaceutical products isn’t always readily apparent to healthcare practitioners and patients. Without the proper controls during transport and storage, sensitive products may experience extreme temperature highs and lows that could compromise product efficacy and safety. Visually, however, the products may appear unchanged.

Inks can change shades based on handling conditions. (click to enlarge)

SafeTScribe Technologies Inc. (Austin, TX) seeks to provide visual indication of temperature exposure with smart ink technology that senses both time and temperature. SafeTMark and TimeMark employ thermochromic irreversible and programmable ink enabled by patented nanochemistry.

“The smart ink technology will create accountability throughout the entire food and drug supply chain from processing and production to distribution, retail, and consumption,” explains Carl Boisvert, president and CEO of SafeTScribe.

“Currently, there is no widely used environmentally interactive system for demonstrating to patients and practitioners proper product storage, handling, and inventory control rotation,” he adds. The ink can provide a permanent history of package
handling.

The ability to detect specific temperature ranges and time periods can be built into the ink’s chemistry, Boisvert explains. For instance, the ink can be formulated to detect specific temperature ranges anywhere between the overall range of –30° to 300°F.

“Each label can become a proactive monitoring device.”

The ink, which can cost as low as a penny or two per label, can be integrated into current packaging and automated labeling systems as well as customized to product specifications and graphics requirements.

Ink is printed using drop-on-demand or continuous ink-jet systems, flexography, rotogravure, and screen printing. Offset is under development.

“We only need a microgram or two to get the job done,” Boisvert explains.

The ink can be printed, stored, and handled until activated by either high-intensity, high-frequency light (SafeTMark low-temperature- threshold ink) or a simple adhesive overlay laminate (TimeMark time-tracking ink.) Both inks can be
activated after printing and even after package filling.

Boisvert says that his company has been working with pharmaceutical companies to validate the ink’s
performance.

“We have been providing a fair amount of ink for testing, and we have demonstrated a high degree of accuracy—plus or minus one or two degrees,” he says. “We provide companies certificates of analysis.” The ink has been tested according to ISO/ANSI standards.

Boisvert suggests the ink as an alternative to RFID technology or electromechanical devices. Given the low cost of the ink and its broad applicability, it could be used widely in order to provide healthcare practitioners and patients with indicators of product integrity while stored in stockrooms, on retail shelves, or at home.

Bar codes printed in the ink could themselves be an integrity indicator.

Additionally, the time-sensing ink could be used to manage inventory in limited-time promotions and value-adds for any product with an expiration date in order to differentiate a brand.

SafeTScribe is currently working with a European company on producing a low-temperature time-temperature indicator for blood bags.

The company is also working on FDA approval of food-grade versions for use as anticounterfeiting technology and as self-expiring pill coatings.

“SafeTScribe’s smart ink technology is the ideal solution to create the highest level of supply-chain integrity for safe, uncontaminated drug and healthcare products,” says Boisvert.

“There is a great need for technologies to impede counterfeiters and to sense handling conditions through time and temperature indicators,” he concludes.

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