Smart Septa System Uses RFID to Authenticate Medications

By Claire Swedberg

The solution is designed to enable health-care-related users to track and authenticate vials or bottles via RFID tags built into a cap's seal and hosted software in which RFID-based data is stored.

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Integrated Line Technologies (ILT), a provider of caps for vials, pharmaceutical bottles and test tubes, has begun marketing a radio frequency identification version of its products that will enable customers to read built-in RFID tags on cap liners and thereby prove that an item is authentic, as well as create and track an electronic history of the product inside a container.

The Smart Septa system consists of EPC ultrahigh-frequency (UHF) passive RFID tags built into the cap liners and in well mats (rubber mats with recesses to store fluids or other contents), as well as a software-as-a-service hosted server that users can access to learn data about a tag and the specific vial linked to it. The solution is being tested by several laboratories that are ILT customers, and ILT is also providing handheld readers to customers that request them. The readers and tags are provided by Serialio.com.

Embedded in each Smart Septa liner is a tiny passive EPC Gen 2 UHF RFID tag.

ILT, based in Rensselaer, N.Y., has been making caps and silicone septa liners for the health-sciences market since 1993, according to Paul Petrosino, the company’s president. A septum (the plural form of which is septa) is a stopper or liner used to seal bottles, incorporated within a cap, forming an air-tight enclosure designed to protect a bottle’s contents. The most common application is the layer of silicone through which hypodermic needles are inserted into a bottle to draw out fluid. The company’s 90,000-square-foot facility manufactures one billion caps with septa liners annually. The caps and liners are designed to seal containers that store medications or laboratory samples, and are typically used by labs, pharmaceutical and health-care companies, or research agencies.

For end users, the management of dozens or hundreds of the containers, which often all look the same, can be a difficult task. They have two concerns: efficiently identifying each vial, as well as what is in it and its history, and ensuring that a medication or other product is not counterfeit.

ILT has developed a technological solution to both of those issues, says Lenny Diaz, the company’s vice president. With Smart Septa, a user’s container cap or well mat comes with a Serialio.com UHF RFID inlay, made with an Alien Technology chip, embedded within the septa during the manufacturing process. The company will now sell caps containing RFID-tagged Smart Septa, as well as versions with standard, non-RFID liners. ILT uses a Serialio handheld reader to encode each tag with a unique ID number that is stored in the Smart Septa software at the time of manufacture. As part of the Smart Septa solution, ILT resells three UHF handhelds from Serialio, though any EPC Gen 2 RFID reader could be used. The three models, says Dave Boydston, Serialio.com’s president, are the idChamp 1128 Bluetooth and USB reader, the idChamp 1126 USB reader, and the Scanfob Ultra-BB2 Bluetooth and USB reader.

After receiving the newly manufactured cap with a Smart Septa liner, an ILT customer can interrogate the liner’s tag via an RFID reader and use the hosted Smart Septa Portal software to link the tag ID to details such as the contents of the bottle to which the cap will be attached. First, however, that customer must sign into the Smart Septa Portal via the Internet and set up its own requirements for tracking, as well as a list of authorized users, such as that company’s own customers, who can then sign in to track the history and authenticity of a particular product or sample within that container.

When a company receives Smart Septa-capped bottles (empty or filled) supplied by that ILT customer, its staff can hold a handheld reader over the vials and view a list of all tags (either on the reader, or on a computer device to which it is connected) that have been read. Workers can then update the status in the software to indicate that those items have been received. Users could also input what is being placed in a given vial, as well as when this occurs, along with any other details that should be tracked with that vial, such as its expiration date or temperature requirements.

When research is being conducted, an individual can read a specific vial’s tag and thus not only view details about it, but also input additional information, via the Serialio reader or a computer attached to that device. Such information could include a description and results of the testing performed. The user can then store the data or export it to a spreadsheet.

ILT’s Paul Petrosino (left) and Lenny Diaz

In some cases, users are concerned that a product could be a counterfeit. To protect against counterfeiting, the tag can be read by the product’s recipient, such as a distribution center or hospital. If a cap’s tag ID is read and its details are displayed by the Smart Septa software, the user knows that the cap is authentic—otherwise, the product might potentially be counterfeit. Typically, Diaz says, the caps are permanently affixed to bottles, but for situations in which they could be removed, there is another potential layer of protection. The bottle could also come with a built-in RFID tag, and the unique ID number encoded to that bottle’s tag would then be linked to the Smart Septa tag ID, in order to ensure that no cap is removed from one container and placed on another one. ILT will work with its partners to provide a means to RFID-tag the bottles.

Currently, several laboratories are using the system with handheld readers provided by ILT, and are utilizing the Smart Septa software to manage data regarding the vials, what is stored in them, and what testing or other processes are being undertaken, such as movement through the chain of custody to a hospital or other end user. Those who request it can also acquire the software as a standalone solution, rather than using the hosted portal.

The price of Smart Septa liners, or of caps with the liners built in, will vary according to the volume purchased. The software can be accessed for a monthly fee, and that rate would also vary based on the number of users. Although several customers are still testing the technology, the company reports, the Smart Septa caps and software are now commercially available.