This invention covers electronic time-temperature indicators with any type
of output (visual, RFID, etc.), and other devices and methods by which the thermal history of a
material may be monitored, and the subsequent fitness for use of the tracked
material may be quickly ascertained. In particular, the invention discloses
a rapidly reprogrammable electronic time-temperature tag that may be easily
customized with the thermal time-temperature stability profile of an
arbitrary material, using electronic data transfer methods. Using this
device, a single, low-cost, generic time-temperature tag may be
mass-produced, and then subsequently programmed to mimic the stability
characteristics of nearly any material of interest.
PCT/US2004/012491 has been allowed in the US,
and is pending in the national phase of most major markets worldwide.
The present invention consists of a time-temperature indicator device that
has at least one parameter set to warn when a therapeutic protein drug has
had a thermal history associated with increased risk of unwanted
immunological activity. The indicator device is designed to remain with the
drug as the drug travels throughout different links of the cold chain. In a
preferred embodiment, the indicator device remains associated with the
therapeutic protein from the time of manufacture up until the final few
minutes before the drug is used. In alternate forms of the invention,
additional parameters, including motion, light, and turbidity may also be
monitored. Novel methods for determining therapeutic protein
time-temperature immunological risk parameters, and programming or adjusting
the indicator device, are also disclosed.
This invention covers improved
electronic time-temperature indicators with an RFID output, and other devices
and methods by which the thermal history of a complex material, which may not
obey a simple exponential Arrhenius law degradation equation, may be monitored,
and the subsequent fitness for use of the tracked material may be quickly
ascertained. In particular, the invention discloses a rapidly reprogrammable
electronic time-temperature RFID tag that may be easily customized with the
thermal time-temperature stability profile of an arbitrary material, using
electronic data transfer methods. Using this device, a single, low-cost, generic
time-temperature tag may be mass-produced, and then subsequently programmed to
mimic the stability characteristics of nearly any material of interest. By
utilizing data compression to compress a material's extensive thermal history
into the small user data field transmitted by modern RFID tags, a considerable
amount of information relating to product status and cause of failure may be
rapidly transmitted within the small memory confines of standard RFID tag
protocols.
Non exclusive licenses are available. For inquiries, call (408) 348-1495 or email
szweig@clinisense.com
