Drug Serialization and Supply-Chain Security - Pharmaceutical Technology

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Drug Serialization and Supply-Chain Security
As regulators work to curb counterfeiting, industry finds benefits to gaining granular data about the supply chain. This article contains bonus online-exclusive material.

Pharmaceutical Technology
Volume 33, Issue 6

Technology solutions

Many products and services exist to fight counterfeiting and improve supply-chain security, ranging from ondosage technology to secure shipping containers to packaging-execution system software. Choosing the right technology for the right product and supply-chain process is key, as outlined below.

On-dosage and on-package technologies. NanoGuardian (Skokie, IL) focuses on placing multilayered security features on tablets, capsules, and vial caps through its brand-protection technology called NanoEncryption. The company has also developed a proof of concept for use of the technology on prefilled syringes. The NanoEncryption process, which adds nothing to the medication, comprises an overt security mark visible to the naked eye, a covert feature that can be seen with a microscope or jeweler's loupe, and forensic-level NanoCodes. Because the NanoEncrypted security features are applied directly to each dose, repackaging is not a factor in determining a compromised product.

NanoGuardian's overt and covert security features are directed at authentication and can be read in the field to detect counterfeits. The nanoscale NanoCodes can be associated with an unlimited amount of data, which can include product, manufacturing, and distribution information. The NanoCodes can only be decoded using specialized equipment and proprietary software housed at NanoGuardian Product Integrity Centers.

To effectively fight counterfeiting and illegal diversion, Dean Hart, executive vice-president of NanoGuardian says, "You need both regulations and technologies, and harsh penalties are also necessary." He recommends on-dose technology as a breakthrough in anticounterfeiting, but believes on-package technologies are still important as counterfeiting increases worldwide. "The escalation in counterfeited and illegally diverted medications calls for greater efforts, including the use of emerging technologies like on-dose technologies, to fight the growing problem," he says.

Another company focused on security at the dosage level is PHARMORX Security (Southborough, MA). The company's imaging technology, ISTARx, captures a magnified image of a tablet, capsule or thin film and can detect areas of interest on the surface. The image can be linked to the primary package and all levels of outer packaging. This information is stored in a database and can be later used to identify the dose.

"If a tablet is found on the street, we can figure out where that tablet should have been in the supply chain," says Steve Wood, president and CEO.

PHARMORX's AuthentiTrack offers serialization capabilities and security measures such as imaging technology and the use of specialty and invisible inks. The product also manages supply-chain data and provides companies with a web interface to monitor supply chain activity. The company also provides hand-held wireless scanners that can authenticate products in the field.

Focusing on packaging and labeling, ATL provides labels that are designed to combat counterfeiting and diversion in the pharmaceutical supply chain. The company's SecurBook labels feature identical forensic markers on pedigree papers, bulk containers, and individual units that can be scanned. Patented, portable-scanning units can verify and authenticate in the field.

The SecurBook labels contain an invisible and nondegradable (to 3000 C) forensic marker. When these markers are applied to pedigree documentation, packaging, and containers, the supply channel becomes secure because all digital data scans must match to ensure brand authentication, explains Donald J. Dobert, president of ATL Pharma Security Label Systems (Menomonee Falls, WI). Other ATL products designed for the pharmaceutical industry include tamper-evident unit closures and anticounterfeiting holograms.

Dobert recommends creating a flow chart of a company's supply chain. Based on the supply-chain analysis, the following should be detected: a likelihood of a security breach, an opportunity for a cost reduction, an absence of enforced standard operating procedures, and an absence of systems and trace audits to measure the performance of the system. The supply chain can then be strengthened by correcting these shortcomings.

Security in the field. Ahura Scientific's (Wilmington, MA) handheld instrument TruScan can be used for product and raw material authentication in the field or in analytical laboratories. The device uses Raman spectroscopy to rapidly identify products and detect counterfeit or adulterated drugs. In a field setting, product samples can be quickly screened to determine whether they are consistent with the authentic formulation; further analysis can be carried out in a laboratory if the exact composition of the counterfeit is needed.

Figure 2. The SMART Container from ODIN is deployable in less than 60 seconds inside any ISO standard shipping container. (ODIN TECHNOLOGOES)
Julien Bradley, director of business development at Ahura Scientific, says dosage form authentication is as important as authentication of a product's packaging. "For many years, pharmaceutical companies focused on making their packaging more difficult to imitate and separately worked with law enforcement to catch and prosecute counterfeiters," he says. "With the introduction of TruScan, many of Ahura Scientific's customers are seeing the value in authenticating not just the packaging, but the dosage form of a product itself—which is what really matters, given that patients don't consume the packaging."

Launched in April 2009, the SMART Container from ODIN Technologies (Ashburn, VA) offers a new level of visibility in the supply chain. A shipping container can not only be tracked in-transit, but the automated system also provides information about the contents of the container. The system combines passive RFID to monitor an item's presence and placement inside a container with sensor technologies to determine environmental state. The system can detect if the container is opened and something removed, and can transmit that information to any enterprise resource planning system via satellite, cellular, and active RFID. The company also provides a web-based service that allows for real-time monitoring of containers.

The SMART Container system consists of a reader, a power source, an antenna array, and an Internet communication device all self-contained in a unit smaller than a typical airplane carry-on. Installation of the system is fast—the magnetic components make it deployable in less than 60 seconds inside any ISO standard shipping container, with no pieces outside the container that can be tampered with.

"Pharmaceutical companies tell us that the biggest problem is the loss of visibility in the supply chain, and the biggest challenge is going from one controlled facility to the next controlled facility," says Patrick J. Sweeney II, founder of ODIN. "The SMART Container is like having two security guards inside the container at all times."


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