Nothing's in the Matter

An identification technology uses a substrate's own uniqueness to authenticate items.

 

 

Drug packagers frown on variability. They typically seek consistency and repeatability in both materials and processes.

It turns out, however, that no two samples of the same material are exactly alike. And that reality could prove useful to the drug packager.

Once a particular carton’s zone is read and registered, none of its lot mates (nor any other zones on the carton) will be mistaken for the registered one.
 

Yann Boutant discovered matter’s inherent variability in what he believed were identical materials more than 10 years ago. He was studying the concept of quality. “I was on a quest for the optimum quality,” he explains. As he examined paper materials at a microscopic level and plotted their “measurements” on a scale, he was hoping that some would intersect to help him identify the ideal. Instead, he found that no two samples of the same material were exactly alike. “Each element was different from its neighbor,” he reports. Boutant eventually concluded that “there is no chance that two materials can have identical configurations.” First studying paper, he later came to the same conclusion with all substrates. He then verified his work with the help of universities, UJM Saint-Etienne and CPE Lyon (France), working to refine his theory.

Random reactions based on the zone’s unique structure are recorded to a database, while common reactions are rejected, and a digital signature is created. The signature can then be tied to a serial number that can be encoded within a 2-D bar code or an RFID tag, says Boutant.
 

Boutant saw an immediate use for such unique identification—item unitary authentication. Forming the company Signoptic (Cedex, France) with partners and investors, he developed the means of creating digital signatures based on unique matter. While his first clients dealt with government documents and private goods, he now seeks to introduce the technology through Cortegra, a leading pharmaceutical packaging provider and their sole U.S. partner for the U.S. healthcare markets. Cortegra will be rolling out the Signoptic technology at Interphex (Booth 2028) this year.

“The beauty of the technology is that nothing needs to be added to the different type of packaging substrates, foil, cartons, labels etc., to achieve such uniqueness, and it does not interfere with existing authentication technologies,” says Narendra Srivatsa of Cortegra. “Even homogenous materials have a random structure, and this allows us to create a unique identification that cannot be duplicated; a forensic, covert and overt signature all in one tool.” Adds Boutant: “This is like a fingerprint—but it cannot be easily duplicated.”

Signoptic’s system works this way: an optoelectronic device excites a predetermined zone within a substrate and then records that zone’s reaction. Random reactions based on the zone’s unique structure are recorded to a database, while common reactions are rejected, and a digital signature is created. The signature can then be tied to a serial number that can be encoded within a 2-D bar code or an RFID tag, says Boutant. “It can be tied to a numerical code within the GTIN format, EPCIS Global format, or other, essentially taking the material information to the digital world,” adds Srivatsa.

The system, which includes software and hardware, can be added to packaging production lines by training the inline reading device to locate zones called out with trigger marks. “Once a package is registered, we feed the IT system with the digital signature data,” says Boutant. An ongoing industrial application demonstrated a reading-and-registering speed of 15 items per second. “It is automated authentication, in real time,” says Boutant. “Some­thing a human being cannot do.”

Boutant adds that because nothing is added to materials and because humans are not needed to make an item unique, the system can protect a company even from its own employ­ees. “Problems arise from human in­volvement. I have seen them in many companies.”

Signoptic has patented these elements of its system: the algorithm that extracts a digital signature from matter, the sensor configured to read both matte and glossy substrates, the system that protects information with the signature [cryptography based on matter properties], and the modification of a cell phone to use the system.

Boutant demonstrated the system to PMP News in Los Angeles using identically produced and printed cartons from Cortegra. Once a particular carton’s zone was read and registered, none of its lot mates (nor other zones on the same carton) was mistaken for the registered one. “Only those zones enrolled were authenticated,” explains Boutant.

Srivatsa believes that other means of making materials unique would work well with this technology. “Taggants, markers, or other additions do not interfere with this technology, and [they] could eventually be eliminated,” he says. “We will try to make it so easy that business can move along as it does today.”

Srivatsa continues: “It is really just a question of looking at the data and the cryptographic algorithms to create the right tools. All companies need to do is create business rules to manage the data and audit the products in the field.”

Having tested the technology by authenticating registered banknotes that have been crumpled, Boutant concludes: “The theory is extremely robust—as robust as the nature of matter.”

 

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