|
 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.
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."
 Fedors 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.
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.
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.
David Vaczek
Senior Editor | 
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