Stability or Shelf-life concerns?

"Is it still good?"

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 trigger.

  • Chemical time-temperature 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 technology section.

Applications:

and nearly any other product where temperature stability or cold chain integrity is critical.

  EN61000-6-1, EN61000-6-3, EN61000-4-2, EN610004-3, EN61000-4-8;  FCC 15B

LifeTrack: think of it as a new type of stability "fuel gauge"

Backward compatible: 

Are you 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.

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