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Volume 5, Issue 12 - December 20, 2007

Envirotainer, a provider of active temperature-controlled air transportation solutions for refrigerated pharmaceutical shipments.

RFID World, the first RFID-focused industry event, and the largest, offering demonstrations of actual solutions and networking with supplier partners delivering the full breadth and scope of RFID.

HealthPack, a conference dedicated to innovations and solutions to help medical device professionals create the next product generation.

RFID For the Cold Chain
By David Vaczek
Senior Editor

As companies assess their cold-chain practices, RFID-based temperature-monitoring systems offer inherent advantages when compared with standard data monitors.

RFID-enabled data loggers have yet to be widely deployed, yet the need to protect high-value, temperature-sensitive drugs will focus increasing attention on RFID cold-chain solutions, says Gene Fedors, vice president, education programs, RFID Technical Institute Inc. (Hatboro, PA).

“RFID is shaping up to be a very effective solution to an acute problem—the protection of high-value substances that can go bad in a relatively short period of time and at a very high cost,” Fedors says.

“RFID-enabled sensors, working with a wireless communications infrastructure, give you something we never had before. You can act on negative events and prevent product from going bad. The more relevant sensory information you receive in real time and the quicker your ability to respond to adverse conditions, the more potential value these solutions will have,” he adds.

Solutions will emerge that incorporate infrastructures for temperature monitoring with capabilities for the tracking of product and supply-chain ownership, promoting RFID’s cost-effectiveness in the cold chain.

“Temperature sensors add another dimension of value to RFID. Having one solution for temperature tracking and one for supply-chain tracking will be too expensive. Over time, there will be one infrastructure that is dynamic and flexible enough to handle multiple tracking metrics,” says Fedors.

In semipassive solutions, tags are programmed to wake up and record events at intervals, providing periodic snap shots of a shipment’s status. A tag LED light signals deviations from programmed temperature ranges. RFID readers wirelessly access the tag data—typically at the end of a shipment—for downloading to analysis software.

“These systems use much lower-cost, simpler tags. The chips can be programmed using RFID, and RFID is used to extract the information noninvasively. You can track temperature in relation to time and location, but you have to manually engage the tags and download the data,” Fedors says.

Semipassive systems impose “greater responsibility on training, policy, procedures, and enforcement to ensure proper execution,” he adds.

Information Mediary Corp (Ottawa) introduced this year a semipassive tag solution with its credit card-sized Log-ic ECM tags. Evidencia (Memphis, TN) is distributing the tags and also offers its ThermAssureRF wireless temperature recorder with programmable chip and transponder technology.

Henry Ames, director of strategic marketing, Sensitech Inc. (Beverly, MA), agrees.

“One of the strongest value propositions for RFID in the pharmaceutical industry will be in the cold chain, because high-value biologics are the future of medicine. The rate of adoption will be driven by the intersection of the regulatory environment and opportunities for return on investment.”

RFID WorldFedors says that cold-chain RF solutions are falling into two categories: solutions using active tags with wireless communication components and stand-alone solutions employing low-cost, battery-assisted semipassive tags.

“Active tag solutions provide real-time monitoring and reporting through the supply chain, but you have the cost and complexity that goes along with implementing the systems infrastructure. Semipassive tags provide a similar degree of sensory data and do not require the extensive infrastructure. But the real-time response capability is limited. How valuable timely information is to protecting your cold-chain assets is the dividing line as to whether you go with one or the other,” Fedors says.

Sensitech offers an active system in its ColdStream Plant-to-Shelf product. Monitor data is automatically uploaded to remote servers and on to a Web-based central repository. Users receive views of time, temperature, and location data that are segmented for the graphic illustration of events. Users can monitor processes and temperature patterns in near to real time and receive automatic alerts via cell phone or pager messaging, such as a temperature drifting out of range. Segmented data can be analyzed for tracing deviations from standard operating procedures arising in supply-chain handling, says Ames.

“When an excursion occurs with a [standard] data monitor, you are getting the information after the fact. You have to go back and look at the logistics information to recreate the shipment,” Ames says.

Fedors says that both types of solutions have their place and will gain adoption “until such time as active RFID components come down in price. We will see parallel development, providing a dual range of solutions. Active-tag continuous-monitoring systems will be favored for high-value, critical supply items, but there are plenty of processes where a full infrastructure would not be justified.”

How will the RFID cold-chain infrastructures develop?

“We are seeing a number of companies that provide real-time tracking solutions adding sensors to move into the cold-chain market. I think we will see third-party logistics providers drive the bulk of the infrastructure build out,” Fedors says.

“3PLs can sell an RFID-tracking solutions as a specialized service in their global networks, as a very attractive value proposition. They can then advise their partners as to what pieces they have to add to complete the solution.”

RFID use in the cold-chain still faces the hurdle of FDA approval, as the impact of RFs electromagnetic energy on sensitive biologics has yet to be conclusively demonstrated. Sensitech has launched a pilot with two drug companies to gauge the impact of its Class 4 tags and readers on biologics.

“We have demonstrated a negligible impact on the temperature in preliminary tests where we bombarded the product at extreme proximity and extreme frequency. We now need to test the impact on the products’ molecular structure,” Ames says.

RFID-enabled temperature systems provide the visibility into cold-chain processes that shippers require as they seek to meet regulations emerging worldwide. Both active and passive solutions make data more accessible by eliminating the need to remove a data monitor from the package. Through the continuous close-to-real-time tracking of supply processes enabled by active tag solutions, quality managers can more quickly identify deviations from standard package handling procedures and pinpoint the supply-chain mishandling that is a major cause of shipment-temperature excursions.

Read the Current
issue of PMP News

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David Vaczek
Senior Editor

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Material of the Month

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