Medical Device Link.

MANUFACTURING

A read-write RFID tag for single-use components enables tracking of the product at every stage, from manufacture to gamma sterilization to end use.

Suited for single-use products, a radio-frequency identification (RFID) tag equipped with read/write capabilities withstands gamma radiation up to 45 kGy and temperatures ranging from –20° to 85°C. Developed by AdvantaPure (Southampton, PA, USA), the tag measures 25 mm diam and is 2 mm thick. Using silicone tape, watchband-style holders, pouches, or lamination, the GammaTag can be attached to such disposable products as sample and production bags, manifolds, tubing and hose, filters, and single-use systems.

“By having a tag that can actually go through the process and retain data, you can have a fully sterilized, yet fully identifiable, lot-traceable item,” explains Jeff Johnson, director of software development. “We can write information on the tag relating to the part number, the serial number, the lot number, or any of the manufacturer’s information, and it doesn’t get separated from the product at any point during production or sterilization.”

Whereas bar codes and tags are read-only identification products, GammaTag allows manufacturers to write data directly on the tag for accurate and updated product tracking. The chip accommodates 2 Kb of memory. Using a handheld tag reader and software, users can also access such data as certifications, use instructions, warning notices, and disposal procedures.

“Right now, the best way of tracking items going through gamma sterilization is through a log book, or with paper, which is fundamentally flawed on many different levels,” says CEO Ken Baker. “This allows the end-user to really have that confidence in removing the risk of tracking a disposable—whether it is a bag, a filter, or a medical device—all the way through from manufacturer to sterilization to the end use environment.”