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Packager Uses Tags to Protect Injectables

West Pharmacuetical Services has released an RFID-based product and service offering to help pharmaceutical manufacturers guard injectable drugs against counterfeiting.
By Mary Catherine O'Connor
Apr 29, 2005Many injectable pharmaceuticals have a high value—a single vial of some drugs can cost thousands of dollars—so counterfeiters can make a significant profit by selling fake or highly diluted versions of the drugs. For this reason, protecting injectable drugs from counterfeiting is especially important to drug manufacturers.

Integrating RFID tags, however, into the packaging for injectable drugs poses significant challenges: Injectable drugs are liquid, and they come in vials sealed with aluminum foil. Liquid and metals can cause RF interference.

The Flip-Off seal with RFID tag
"We have the two biggest enemies to RFID functionality as part of our package," says Carol Mooney, market manager for injectable drugs for West Pharmaceutical Services, a Lionville, Pa.-based manufacturer of packaging and components for drug delivery products. But finding a way to use RFID in its vial packaging has been a priority for the company since the Federal Drug Administration formed its counterfeitdrug task force in July 2003. The task force recommended that a number of technologies, including RFID, be used by pharmaceutical companies in order to prevent counterfeit drugs from entering the pharmaceutical supply chain. Earlier this month, West Pharmaceutical Services debuted West Spectra, a product and services package that employs RFID technology to help manufacturers of injectable pharmaceuticals fight drug counterfeiting and tampering.

Around the time FDA formed its task force, West developed a partnership with Doylestown, Pa.-based RFID systems developer TAGSYS to integrate RFID tags in West's trademarked Flip-Off seal, which consists of a round plastic button and a tamper-evident aluminum seal that covers the rubber stopper used on glass vials. Mooney says West Pharmaceutical Services considered other RFID vendors but was impressed with the depth of experience that TAGSYS has in pharmaceutical applications, which includes a deployment of water- and temperature-resistant TAGSYS tags that were attached to surgical garments for an inventory application and also a trial in France where TAGSYS tags were embedded in the caps of test tubes containing biological samples preserved in liquid nitrogen. West also believes that TAGSYS tags are robust enough to withstand the rigors of both the West's manufacturing process and also the shock and vibration the vials are exposed to as they move through the supply chain.

Mooney notes that when RFID tags have been applied to the glass body of vials in test pilots, there have been high failure rates in reading the tags because the chips are often damaged during transport. By integrating TAGSYS' RFID tag into the inward-facing side of West's Flip-Off seal, the chip is protected. By placing the tag on the top of the vial, the reader can pick up its RF signal more easily than if the tag were integrated into a label on the side of the vial.

John Jordon, president of TAGSYS' U.S. operations, says that West wanted to use a high-frequency (13.56 MHz) RFID tag because such a tag offers a high level of readability despite the vials' metallic seal and liquid contents. He believes that using UHF on the vials would have been out of the question because the level of readability would be significantly lower. "You just plain couldn't get UHF to do the job nearly as well as HF," he says.

TAGSYS is using a Philips Icode 1 RFID chip in its Spectra product. The chip does not meet any ISO standards, but Jordon notes that it has become a de facto standard among HF applications and that most readers on the market are interoperable with tags made with Icode chips. Jordon says the chips can be quickly encoded and read: More than 150 of the Icode tags can be encoded per minute, and more than 500 can be read per minute.

Drug manufacturers will write an EPC code, and possibly other data pertaining to the drug, to the RFID tag in each Flip-Off seal, and this tag will be used to track and trace the product as it moves through the supply chain. The standards and processes that manufacturers, supply chain partners, wholesalers and retailers will need to follow in order to maintain electronic pedigrees for drugs have not been finalized. But Mooney says she is confident that the technologies used in the Spectra offering will fit within those standards as they become finalized through the FDA and EPCglobal. She says that users of the Spectra product could also use the RFID tags to automate their inventory-taking processes.

An additional benefit of the Spectra Flip-Off seal is that once the entire seal is removed, it cannot be reattached. This is because the structure of the aluminum foil seal under the plastic button changes when it is removed. The plastic button that sits on top of the foil seal, however, can be removed without compromising the integrity of the foil seal. Important drug information, such as recommended dosage and expiration dates, can be printed on the aluminum seal. This will allow users of the drugs to remove the plastic button containing the RFID tag at the point of purchase—which they might want to do so that the RFID tag does not remain with the product as they leave the pharmacy—without also removing important prescription information and without compromising the integrity of the drug inside the vial.

One major global pharmaceutical manufacturer, the name of which neither TAGSYS nor West could disclose, is currently conducting a pilot test of the West Spectra packaging. Jordon says this testing consists of tagging a small quantity of vials and putting them through the pharmaceutical maker's supply chain. When they reach their final destination, whether a pharmacy or a hospital, the vials' tags are read to certify that they are still functioning. The tagged vials, however, are not being sold or administered. Mooney says West is in discussions with a half-dozen other pharmaceutical companies that are also interested in testing the packaging.

TAGSYS will deploy RFID readers and antennas at the facilities of West's customers and also integrate the data generated from the item-level reads into the users' legacy enterprise resource planning systems. But West will act as the main point of contact for its Spectra customers, coordinating the hardware deployment and service visits between TAGSYS and West's customers. Mooney says West will offer to integrate other technologies for authentication into the Spectra offering, according to the customer's wishes. The Spectra product and service offering is available now; pricing will be negotiated depending on the size and specifics of each deployment.
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