Track & Trace: RFID Tops Off Drug Vials
A packaging component supplier and an RFID tag manufacturer collaborate to bring RFID to one of industry’s most demanding products—the liquid-filled, metal-topped vial.
|The West Spectra incorporates several layers of overt and covert anticounterfeiting solutions, including RFID.|
Liquid and metal are often seen as barriers to radio-frequency identification (RFID) use with drug vials. But a new solution from West Pharmaceutical Services (Lionville, PA) and Tagsys Inc. (Doylestown, PA) may help companies avoid these roadblocks.
At the Parenteral Drug Association (PDA) meeting in Chicago in April, West debuted West Spectra, a modified version of the Flip-Off seal for vials. The technology incorporates several layers of overt and covert anticounterfeiting solutions, including RFID. West will be integrating RFID tags from Tagsys into the manufacturing of the seals. Other technologies that can be included in West Spectra include the use of spectroscopic inks and forensic elements.
Carol Mooney, market manager for injectable products for West, says West Spectra is the firm’s next-generation proprietary technology for customization of plastic buttons and aluminum seals. “We started looking at solutions when FDA formed its anticounterfeiting task force in 2003,” she says. “When counterfeiting occurred in U.S. injectables, we enhanced our closures with embossing, custom color coding, lacquers, and additional printing. We then started looking at advanced technologies, such as taggants, color-shifting inks, and RFID.” West needed to make sure that any new authentication technology could be incorporated into its seal manufacturing process.
|Tagsys Inc. offers this smart vial system, designed to monitor product movement. The company also produces smart shelves and smart refrigerators.|
RFID was important, says Mooney, because “FDA recommended its use by 2007 to combat counterfeiting.” Since pharmaceutical manufacturers had expressed concerns about incorporating RFID into drug-vial labels, the vial seal presented itself as the ideal solution. “Tagsys realized early on that the seal was a better place for RFID than the label,” says John Jordon, president of Tagsys. “West immediately saw the benefit.”
The two companies then started working together to find a way to integrate RFID into seals. The solution had to be robust enough for West’s manufacturing processes and to withstand the rigors of pharmaceutical processing and packaging, which often includes seal sterilization.
Tagsys decided on a 13.56-MHz chip from Philips Electronics. “It is a very efficient chip, and it is widely available, so everyone can read it,” explains Jordon.“The frequency works well with liquids and metals.” The chip can be used for write-once, read-many or secured read/write applications. “It offers fast read/write rates,” adds Jordon. Because of its frequency, the tag must be read within one foot of the reader.
The tag design is well proven in harsh applications, says Jordon. “This tiny 8.9-mm tag form factor is currently being used for tissue samples that are cryogenically frozen and on reusable surgical garments that are autoclaved up to 125 times,” he says. “It has a failure rate of less than one in one million.”
By incorporating the RFID tag into the seal, some of the quality concerns that pharmaceutical manufacturers have with RFID labels are avoided. “Because the tag is on a flat surface, we prevent the breakage of the tag,” says Mooney.
“By having the tag fixed on the tops of vials, companies can control RFID tag orientation,” Jordon explains. “If RFID is used on labels, two tags could line up and cancel each other out.” Tests have determined that RFID tags “facing up” minimize interference with the product or its package, i.e., liquids or metals.
Both Tagsys and West are aiming to provide tags with zero failure rates. “We are looking at releasing 100% active product,” says Mooney. “We are planning to read 100% of the West Spectra seals before we ship.” West has been adding manufacturing and inspection equipment to its facilities in Montgomery, PA, and Clearwater, FL, to support this initiative.
|West’s modified Flip-Off seals for vials now feature additional security features.|
West and Tagsys are also working together to provide the support pharmaceutical manufacturers will need to implement the technology, explains Don McMillan, vice president, marketing, Americas Region. “Pharmaceutical firms don’t need a stand-alone system when implementing RFID. They need a system that can work with their information technology infrastructure,” he adds. Tagsys will support West’s distribution of West Spectra by providing associated hardware and data integration services. Tagsys’s offerings also include smart shelves and smart refrigerators that can be used to monitor product movement in hospitals, laboratories, or pharmacies.
Mooney reports that West Spectra had a good reception at PDA. “Attendees spoke of their struggles to add RFID to parenteral vial labels, so they received this product well.” She expects interest to build. “Pharmaceutical manufacturers need a cost-effective way to control inventory, especially to track unlabeled vials,” she says. “They need to avoid product mix-ups and ensure that the right drug goes into the right carton. And they need to be able to rapidly recognize counterfeit products in the supply chain. We made West Spectra flexible enough to handle these tasks.”