Intelsius, ATI Team with Data Logger Solution

The companies foresee growing pressure for monitored shipments.
Intelsius (www.intelsius.com) in a partnership with American Thermal Instruments (ATI; www.americanthermal.com) will include a complementary ATI LOG-IC electronic temperature data logger in every refrigerated and controlled-room-temperature shipper.
 
Customers can specify any of ATI’s range of data loggers, with the opportunity to compare their performance with alternate loggers they may have already qualified. The loggers will be integrated in Intelsius’ Orcatherm, BioTherm, and
PharmaTherm shippers, says Andrew Mills, CEO, Americas division, Intelsius.
“This is the first time this type of partnership has occurred in the industry. At the end of the day, it’s all about patient safety and making sure the patient gets a product that won’t cause adverse reactions.
 
 “Ultimately [also], we are giving our customers visibility into what is happening in their cold chain so manufacturers do not lose product in transit,” Mills adds.
The partnership includes a combined sales and marketing program. The companies collaborated to develop devices and device software to Intelsius parameters. As Intelsius shippers are designed as 100% recyclable, “we wanted to make sure the logger was removable so it would not be entered into the normal recycling waste stream,” Mills says.
 
FDA 21 CFR Part 11 compliant loggers, LOG-IC devices support transmission of logged data by USB port or wirelessly via RF technology. Base model Tracker tags offer high and low excursion data showing how long programmed temperatures were exceeded. Logger tags offer more complete temperature profiles.
 “The LOG-IC data logger is a very flexible device. We can place it directly into the payload or, alternatively, with our probe device, the data logger fits in a slot at the top of the lid. Intelsius shippers feature a built in channel for the probe,” says Matty Toomb, vice president of sales and marketing, ATI.
 
 “With the LOG-IC data loggers, we feel we are offering unique logistics support and software reporting capabilities at a significant cost advantage compared to competing solutions. One of the key advantages is the form
factor—the devices are the size of a sugar packet, so you are maximizing payload space,” Toomb adds.
 
New European Medicines Agency guidance supports the use of devices that can capture and report temperature histories, Mills notes.
For ensuring that investigational drugs are kept under suitable conditions in transport between the manufacturer or distributors and investigator sites, the EU GMP guidance states: “Storage conditions during transportation should be validated and/or monitored using a suitable temperature measuring device, capable of showing fluctuations in temperature, e.g., temperature logger.”
“Chemical indicators will tell you something has occurred, but they won’t tell you how long the excursion lasted. In 2009, we saw well-documented cases in distribution of the H1N1 vaccine [when damaged product] led to FDA recalls,” Mills says.
“CDC estimates 17% to 37% of providers in the $4 billion U.S. vaccination and immunization program exposed vaccines to improper storage temperatures. If you were using data loggers consistently to better understand your lanes, you could save $1 billion worth of drugs being lost. There is a good case to be made for using data loggers to save money,” Mills adds.
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