In test labs, your product's
stability experts can constantly monitor the temperature history of your
perishable products, analyze this data versus an extensive stability database,
and instantly warn if your product has deteriorated. But what do you do
for products in the field?
"That new study said what? ..."
Sometimes, new data can show that
storage methods that were formerly believed to be adequate may not be. For
example, in 2008, Koch et. al., "Duration
of Red-Cell Storage and Complications after Cardiac Surgery", NEJM 358:
1229-1239 showed that blood-bank red cells are more storage sensitive than
previously believed. Although regulations allow up to 42 days of
storage, the study showed that use of fresh (14 days or younger) red-cells gives
superior 1-year mortality rates (7.4% vs 11.0%, P<0.001). The data is
compelling, but simply throwing out all red cells after 14 days of storage is
not logistically feasible because the blood banks will run out of blood.
What to do?
For problems like these, and
other problems, a stability "fuel gauge" -- an indicator that lets you know at a glance if the
material is still good, or is still compatible with new storage criteria, can be
useful. However you probably aren't having much luck
finding this. Temperature loggers, temperature alarms, and chemical
time-temperature integrators all have major drawbacks.
Temperature logger data must be
downloaded and interpreted by stability experts to be useful. This is
extremely slow, labor intensive, and expensive, and fails to promptly warn
users in most situations.
Temperature alarms, which trigger
when a preset time-temperature criteria is exceeded, usually won't work. What
if your product sits for a long time at a temperature one degree away from the
preset alarm value? Your product may still go bad, but the alarm will not
indicators are often inaccurate. They are difficult to customize, often do
not fit a product's real stability characteristics (e.g. monitor damage due to
both heat and cold), and are usually difficult to read.
LifeTrack -- the stability "fuel
gauge" you're looking for. This device can be quickly programmed to
exactly duplicate the time-temperature stability characteristics of your
material, and let you know, at a glance, how much remaining stability
lifetime is left.
Improved safety: In view of the Supreme Court's recent decision in Wyeth v Levine, do you want to risk the foreseeable problems that can be caused by the inadvertent use of deteriorated product?
Why CliniSense? Simple
-- we invented the concept and hold the patents
(contact us if you are interested in a non-exclusive license).
How does it
work? A detailed discussion can be found in our
LifeTrack: think of it as a new type of stability "fuel gauge"
presently using an analog time-temperature indicator, but are not totally happy
with it? We can program our
demonstrator unit to replicate any standard analog time-temperature indicator. If the TTI that you are presently using has some characteristics that are not ideal,
let us know, and we can program our device to do exactly what you want.