A single-use, ascending time-temperature indicator which alerts users to cumulative time of the exposure to unacceptable temperature conditions. The indicator is field armable with pull tab.
The client is a major player in the medical industry whose focus had been on the last mile delivery of flu shots. It was imperative that their temperature-sensitive flu vaccines were delivered within the exact temperature-range needed so that the flu vaccines do not lose effectiveness.
"Even once the vaccine shipments have arrived at healthcare facilities and have been stored in purpose-built, pharmaceutical-grade refrigerators, they still may experience temperature excursions."
With so many vaccine doses being shipped to pharmacies, physicians’ offices, and hospitals globally, there is a risk of mishaps. Temperature excursions are among the many things that can go wrong. Despite careful packaging in insulated cartons that have been certified and validated, vaccines lose their effectiveness if those cartons are damaged. If weather conditions change or shipping is delayed, it can cause cold packs to thaw, or if routing mistakes occur.
“Potency is reduced every time a vaccine is exposed to an improper condition,” according to the CDC’s 2021 Vaccine Storage and Handling Toolkit. The harm isn’t necessarily visible, either, because the appearance of the vaccine often doesn’t change in relation to inappropriate temperatures.
Even once the vaccine shipments have arrived at healthcare facilities and been stored in purpose-built, pharmaceutical-grade refrigerators, they still may experience temperature excursions. For example, refrigerator door gaskets may not seal properly or refrigeration equipment may fail completely. Alternatively, the refrigerator may be placed near heating vents or in sunlight, causing internal temperatures to fluctuate and possibly damage the vaccines.
Therefore, this clients goal was to find a temperature-controlled solution that maintained efficacy of flu vaccines during shipment from their distribution centers to doctor's, offices, clinics and hospitals.
Without a time-temperature indicator inside the package, healthcare professionals have no easy way of knowing whether the vaccines experienced a temperature excursion.
WarmMark® was the ideal solution for monitoring vaccine temperature during shipping, and even during storage. This single-use, time-temperature indicator monitors for cumulative temperature excursions above a predetermined threshold.
The WarmMark is available with thresholds between -18° and 37°C. When the cold chain is broken for a specific duration, the WarmMark windows change from white to red. The WarmMark temperature indicators trigger only when product temperatures have exceeded a specific temperature for a specific period of time. With at-a-glance ease, the healthcare professionals knew instantly whether the vaccines maintained proper temperatures during shipping. These indicators gave them added confidence that the vaccines have maintained their efficacy.
Not only that, but the indicators were easy for shippers to use, too. They simply just had to pull the activation tab and the indicator was ready to go. Then they placed the WarmMark monitor inside the packaging as close to the product / vaccine as possible.
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