Jul 24, 2015Cryogatt Systems Ltd. is marketing a solution for the RFID-tracking of cryopreservation specimens that combines HID Global's Piccolino passive 13.56 MHz high-frequency (HF) RFID tags, made using HID's Vigo direct-bonding technology to attach each tag's antenna and its chip, and Cryogatt's reader and software platform. Both the readers and the tags are designed to operate at temperatures down to -321 degrees Fahrenheit (-196 degrees Celsius). The technology is now in use by several cryopreservation laboratories that store human pathology samples, as well as blood and tissues, for genetic reference purposes.
For two years prior to the solution's commercial release this year, the companies conducted testing with the National Institute of Biological Standards and Controls (NIBSC), an England-based organization that focuses on biological medicines, develops related standards and reference materials, provides product control testing and carries out applied research.
"The cryogenic storage industry faces many challenging hurdles while maintaining the correct freezer temperatures for stem cell vials," says Philippa Kennedy, Cryogatt's director. Such freezers operate at -80 degrees to -196 degree Celsius (-112 degrees to -321 degrees Fahrenheit), and live research material and fertility specimens are stored at similarly low temperatures. Organizations that manage the specimens must comply with government mandates and handling procedures.
Historically, cryogenic samples are typically stored in glass or plastic vials and thin tubular containers known as straws. At most institutions, they have been identified by means of handwritten or printed labels—and, more recently, by bar-coded labels—attached to those straws and vials. When material samples are stored at extremely low temperatures, vials are subject to intense frosting, making printed or bar-coded labels difficult and time-consuming to read. The labels are also prone to falling off. "It is vitally important to protect each sample from being damaged by a rise in temperature during the inventory process," Kennedy explains. Additionally, labels can become dislodged or illegible with the collection of frost on the container's surface. Workers must often locate and identify a particular vial or straw quickly, and it is during this process that mistakes can occur.
To prevent errors and meet mandates, laboratories conduct regular audits. However, auditing each sample is time-consuming and typically requires two staff members working under strict health and safety timelines. Sample racks hold approximately 100 vials or straws, with each freezer containing many hundreds of such racks. Employees must manually identify every single straw or vial by reading each individual label, Kennedy says—a process that averages a 9 percent error rate. "These errors can result in legal damages," she states, "and are frequently quoted in the press."
RFID offers a better alternative, Kennedy says, assuming the hardware can survive low temperatures. Until now, she adds, RFID solutions did not address these types of harsh environments, as such low temperatures are typically outside the specification of tags and readers.
When Cryogatt began development, it purchased several hundred Piccolino tags from the UK HID Global representative, which it then tested at cold temperatures. The company determined that the tags did, in fact, perform well at the temperatures found in cryogenic environments, Kennedy reports. Cryogatt then requested a tag from HID Global that could consistently operate at low temperatures in a very small form factor.
While the Piccolino tags were being developed, Cryogatt also designed and built the required form factor of readers for two use cases: reading vials as they were first input into the system, and interrogating tags on vials loaded in boxes and trays within freezers. The firm also created a software platform specifically for tracking cryogenic specimens.
HID Global released its Vigo bonding technology in January 2014 (see HID Global Intros 'Smallest High-Frequency Direct Bonding Technology'), to enable the creation of very small tags with chip and antenna bonded without the added bulk of housing or additional soldering material. Piccolino tags are compliant with the ISO 15693 standard, and the versions used in this application measure 9.5, 7.5 or 6.5 millimeters (0.4, 0.3 or 0.26 inch) in diameter and 1 millimeter (0.04 inch) in thickness, says Richard Aufreiter, HID Global's director of product management.
In early 2013, NIBSC purchased a complete Cryogatt "stock control and audit system." And in June 2013, the agency launched a system reliability trial, periodically testing tags and the system with the tags being permanently stored at -196 degrees Celsius.
The solution being tested at NIBSC consists of vials and storage boxes or trays, each with an embedded Vigo Piccolino tag. Cryogatt readers are used to interrogate those tags, thereby enabling lab personnel to identify, locate and audit samples throughout their storage life cycle in freezers.
NIBSC's Genetic Reference Materials department was interested in reducing the amount of labor and the potential for errors in manual vial sample tracking. Department personnel had used both printed and bar-coded labels, but had found that the labels were falling off in the freezers, or were misread due to frost.
For the pilot, Cryogatt attached tags to NIBSC vials and entered the ID number for each vial's tag into the Cryogatt software, which linked that ID to an "accession number" stored in the laboratory software used to identify a patient at the hospital, a treatment program and the specific strain of biological tissue. Once a sample was placed within the vial, the sample's accession number, patient name and brief history were linked to the tag's ID number in the Cryogatt software.
A Cryogatt reader with an integrated antenna was installed at the area in which samples are prepared. In addition, a similar reader was located in a freezer room for entering and retrieving the samples to or from cold storage.
"This reliability trial continues," Kennedy says, "and now, after two years, we have had zero vial tag failures and zero reader or system failures." The testing included reading boxes of 100 tagged vials repeatedly throughout the past two years without failure, she reports. NIBSC is continuing to trial the technology, with no end date yet set. NIBSC did not respond to a request for comment.
In August 2014, the Cryogatt-HID solution was also installed within a chest freezer at Bristol Royal Infirmary. "We are in discussion with 43 other establishments in the U.K. at present," Kennedy states. "The market throughout the world is enormous."
Independent of the cold environment, Aufreiter says, the Vigo version of the Piccolino tag is used in many other RFID applications for which a small, embeddable form factor is key. For example, the tags are in use for brand protection, as well as the automated identification and management of consumable industrial goods, like cartridges or tools.
