Dec 11, 2006Many expect RFID tags to become a far more integral part of pharmaceutical operations—from tracking drugs traversing the supply chain to helping companies monitor and manage drug production. The latter, however, often requires specialized tags that can withstand critical manufacturing processes used by pharmaceutical companies, such as sterilization with electromagnetic radiation or gamma rays.
To meet this need, AdvantaPure, a Southampton, Penn., manufacturer of tubing, fittings and related components for the pharmaceutical, biomedical, food and cosmetic industries, has introduced the GammaTag, a passive, high-frequency (13.56 MHz) RFID tag designed to withstand gamma radiation up to 45 kGy (kilograys). The read-write tag complies with the ISO 15693 standard and is designed to withstand sterilization processes used in "cleaning in place" (CIP) systems, which automatically clean and disinfect components without major disassembly and reassembly work.
Founded in 2001, AdvantaPure, is a division of NewAge Industries, a 52-year-old, family-owned company that manufactures tubing, hoses, fittings, clamps and associated items for a broad range of industries. Shortly after AdvantaPure introduced its product line of tubing components, some of its customers begin asking for a way to track items that would ensure they were regularly checked for quality, replaced when needed and installed and monitored properly.
"These companies are making expensive drugs, and if a hose starts leaking, you might have a multimillion-dollar batch of drugs on the floor," says NewAge Industries' CEO, Ken Baker. "And you could have a contamination issue. It isn't just a lost batch—you could have an environmental problem."
Therefore, AdvantaPure developed its Hose Track system, featuring an ISO 15693-compliant RFID tag able to withstand the high temperatures used in pharmaceutical manufacturing and steam sterilization. The RFID system included a handheld RFID interrogator and a user database that companies can utilize to store and analyze tag readings. The tags were initially affixed to hoses and other tubing, and were later added to AdvantaPure's line of valves, pumps and filters.
Prior to use, these polymer bags must first be sterilized with gamma rays, which have a very high energy content and can penetrate dense materials, causing serious damage when absorbed by living cells. To protect the chips from gamma radiation, AdvantaPure uses a proprietary application of existing technology. The company declined to divulge any further details, though Jeff Johnson, director of software solutions at AdvantaPure, says the tag does not store the data in magnetic format. "If it were in a magnetic format, there's the potential for the gamma ray to destroy the data," Johnson says.
With the GammaTag affixed to the disposable bag, companies can encode the tag's 2 kilobytes of memory with a variety of information about the bag. This includes who made the bag and when it was made, as well as data about the bag's tubing, hoses, filters, clamps and other associated components. Once the bag is sterilized via gamma radiation, information about that process—such as who did the procedure, when and where—can also be encoded into the chip.
The encoded tag, as well as all data associated with it, can be stored in the database to create an electronic document used for verifying how the drug was handled. "The FDA wants records on all of this," says Baker.
AdvantaPure has enlisted a third-party radiation company to run performance tests on sample GammaTags. The tests involve programming the tags, exposing them to different levels of gamma radiation and testing to see if the tags' data can still be read after exposure—and if the tags can be encoded with new data. AdvantaPure expects the firm to complete testing within two weeks.
So far, AdvantaPure has filled only small sample orders, but Baker says a lot of companies, including pharmaceutical companies and original-equipment manufacturers, are evaluating the tags. The company expects pricing to be no less than $3 or $4 per tag, though Johnson predicts the cost will drop as order volumes rise.
