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These
applications are varied">
Return to Main
Page | Contact Us | Sales Information
·
These
applications are varied, and depend upon the regulatory environment, the
type of product or material, and the published time-temperature tolerance of
the product based on potency and effectiveness testing. The field is
complex, but certain generalizations are possible:
CRT Pharmaceuticals
A large fraction of 'pills'
and other preparations are classified as "controlled room temperature"
pharmaceutical products. The criterion for time-temperature tolerance
of these products is the following definition: "A temperature maintained
thermostatically that encompasses the usual and customary working
environment of 20° C to 25° C (68°-77° F) that allows for brief deviations
between 15° C and 30° C (59°-86° F) that are experienced in pharmacies,
hospitals, and warehouses."
The greatest difficulty with
this CRT criterion is that shipping and mail/express service delivery of
CRT-designated products typically exposes them to temperatures that are well
outside the defined limits (below 15° C in winter and above 30° C in
summer). Thermal abuse outside the CRT envelope compromises potency
and perhaps represents a major heath problem. There is no assurance of
the effectiveness of transit temperature conditioning, and the vagaries of
delivery to homes almost guarantees that a certain percentage will be
temperature damaged.
Our CheckPoint®
III labels are ideal for monitoring of CRT pharmaceuticals, as they are
specifically adapted to indicate very rapidly when exposed to temperatures
outside the upper criterion for CRT conditions.
Temperature labels are
generally designed for use at chill and frozen temperatures, so their use at
room temperature is subject to some question. Our L series labels may
possibly be suitable for transit high temperature protection for CRT
pharmaceuticals shipped over a few day time span. The L series
response to temperatures over the limit is appropriate to the type of
shipping protection that is required.
Vaccines and Special
Preparations
Certain vaccines, serum based
products, and pharmaceutical devices are susceptible to above chill
temperatures. These would be well suited for CheckPoint®
protection. Generally, our B series or L series labels are best for
these applications. Each particular item in this general category has
specific temperature requirements, and these can be fitted with custom
formulation in short runs (a specialty that is easy to achieve with
CheckPoint®
technology).
Call us to set up a trial
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