Developing thermally controlled transportation (1)
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Once testing is completed successfully, process implementation occurs. Provisions also should be made for training, quality
assurance, maintenance of appropriate records for regulatory inspectors, and periodic reevaluation. The latter is necessary
because "Even a qualified process is subject to change over time" (1).
Additional resources.
Technical Report No. 39 also includes a list of references, a glossary of terms, an appendix describing International Conference on Harmonization (Geneva, Switzerland,
http://www.ich.org/) and World Health Organization (Geneva, Switzerland,
http://www.who.int/en/) stability tests, and an example of a study design for a refrigerated product. Finally, a sample transportation control strategy
document outlines the effect of various temperature excursions on a particular product and advises whether it can still be
used and to what degree the shelf life has been affected.
Regulators also continue to work on cold chain management. Health Canada (Ottawa, ON, Canada
http://www.hc-sc.gc.ca/index_e.html) issued the final version of its guidance document, "Guidelines for Temperature Control of Drug Products during Storage and
Transportation," in October 2005 (2). It contains specific recommendations for production transportation, containers, and
container labeling.
Cold chain management tools
Drug makers have many options to help ensure temperature-sensitive products move through the supply chain under appropriate
conditions, including time-temperature indicators, data loggers, radio frequency identification (RFID) technology, and insulated
shippers and refrigerants. Several products and vendors have come to light since previous articles on this topic appeared
(3, 4).
Pressure-sensitive temperature indicator labels integrate phase-change chemistry to irreversibly change color and provide
a visual indication that thermal parameters have been exceeded. Customized designs can be set to thresholds from 0 to 200
°C and are produced in an ISO-9001:2000-certified, FDA-registered facility. Labels can be supplied on rolls for automated
application (Customized Irreversible temperature indicators, American Thermal Instruments, Inc., Beavercreek, OH,
http://www.americanthermal.com/). The company also offers a stock-freeze indicator (Freeze√ Freeze Indicator).
A disposable, electronic temperature indicator, developed by a supplier of refrigerants and insulated shipping containers,
reads "OK" if a shipment has not been temperature abused in transit. Each unit is programmed to the customer's time–temperature
requirements and then tested to make sure it is reading accurately. The battery-powered unit weighs only 0.5 oz and can function
as long as two years after activation. Double-sided tape affixes the indicator to the product being stored or shipped (KoolWatch
electronic temperature indicator, Cold Chain Technologies, formerly FDC Packaging, Holliston, MA,
http://www.coldchaintech.com/).
An advanced data-logging system incorporates monitoring and alarming software to provide deviations alerts. Rather than recording
data at a single location like traditional monitoring systems, the software monitors temperature and humidity using data loggers
arranged in a network throughout a shipment or site. The software connects to the independent data loggers and provides a
centralized way to view the information. Distributing data-recording responsibilities among multiple sensors also enhances
system reliability. If one sensor fails, others continue monitoring conditions (viewLinc Enterprise monitoring and alarming
software, Veriteq, Richmond, BC, Canada,
http://www.veriteq.com/).
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