Sterilization Solution for RFID

Gamma radiation approved on Millipore’s radio-frequency identification tags.

By Anastasia Thrift

Life sciences technology provider Millipore (Billerica, MA) has received a European Union patent for using RFID in gamma radiation. The patent covers systems and methods for sterilization and is titled “Use of gamma-hardened RFID tags in pharmaceutical devices.”

Millipore can tag disposable biocontainers and filtration products with a gamma-stable RFID technology.

The company promotes this new technology as a way to quickly access critical information through disposable solutions. Disposable, presterilized process components are touted as a way to configure systems to meet specific customer needs and eliminate expensive cleaning operations.

“Gamma-stable RFID technology can be used to address labeling needs as well as provide a means of wireless communication between consumables, hardware, and systems,” says George Adams, RFID program manager, Millipore. He says the industry has long recognized gamma sterilization as a highly effective and robust means of rendering raw materials and finished products sterile “We see uses for it on filters, biocontainers, and many other items.”

“When incorporated into disposable biocontainers and filtration products, like those found in Millipore’s FlexReady solutions [due early next year], RFID will ensure that the right filtration technology is used for a given unit operation, from intermediate process steps to final filling, and provide this capability to track contents,” Adams says.

The Millipore tag’s memory device utilizes a technology unaffected by gamma radiation, and the patent covers systems and methods for its use in biopharmaceutical environments. RFID tags may be applied to various components during manufacturing or immediately after final assembly and can be subjected to gamma sterilization without risk of data loss or corruption.

“Patent applications must pass through a rigorous in-house process in which we can ensure that the technology is novel, meaning it doesn’t already exist, and that it works,” Adams says of how the company obtained its patent. “Millipore strongly believes that technological innovation is a key element to keeping pace with customer needs. With so much effort placed toward delivering useful innovation, we have a parallel process in place to preserve it for our customers.”

Millipore uses 13.56 mHz frequency for its tags because its relatively short read range of 12 in. makes it ideal for item-level tagging. Adams says this frequency has been proven to be immune to interference in pharma environments. This frequency also was recently deemed the standard by ANSI for medical devices. ANSI/HIBC 4.0 addresses electromagnetic interference of RFID, and HIBCC recommended the frequency for healthcare item-level tagging because the short read range is less likely to result in electronic magnetic interference with medical devices.

The Millipore tags will hold approximately 2000 alphanumeric characters and store item information—description, catalog number, lot number, serial number, selected quality specifications, and expiration date. “And, of course, still leave room for the end-user to write batch information,” Adams says.

Multiple methods are used to attach RFID tags. Basing the tag implementation method on the application, Millipore chooses from adhesive-backed labels and irremovable embedded tags.

This method expands the company’s SMART RFID platform to be gamma-compatible. Millipore hopes to achieve patents in the United States, China, India, Singapore, and Japan next.

“Our choice to include a read/writer in our FlexReady systems, while not a necessity, will make adoption and use of RFID-enabled disposable components easier than obliging users to source, validate, and use their own equipment,” Adams says. “Still, we recognize that some of our customers will choose to buy and install their own read/writers, so we will be sure to keep the communications structure of our tagged products as open and flexible as possible.”

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