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SpotSee|7 May 2021

WarmMark® Time Temperature Indicator

WarmMark is a single-use, ascending time and temperature indicator that not only changes color when temperatures warm to a specified threshold, but also indicates whether exposure to that duration is brief, medium, or prolonged based on that sensor’s specific temperature threshold.

WarmMark is a single-use, ascending time and temperature indicator that not only changes color when temperatures warm to a specified threshold, but also indicates whether exposure to that duration is brief, medium, or prolonged based on that sensor’s specific temperature threshold.

Although pharmaceutical products can be damaged by excessive heat, that damage isn’t always total. Some products remain safe and efficacious despite brief or moderate temperature excursions. In these cases, using sensors that accurately monitor both the extent and duration of temperature excursions is an important strategy to ensuring product safety throughout your cold chain.

Many Temperature Thresholds Are Available

WarmMark time and temperature labels are available in a wide range of temperature thresholds, three of which are designed specifically for COVID-19 vaccines. The COVID-19 temperature labels have thresholds at 2°C/35°F with a 48-hour run-out, 8°C/46°F with runouts at 6 hours and one at 14 days, and 25°C/77°F with a 6-hour runout. This means these labels can be used at vaccine distribution facilities – such as mass vaccination sites and clinics – as well as during shipping.

Within the broad WarmMark product line, the lowest-temperature indicator features duration-of-excursion warnings (spots) that turn red after 1, 3, and 12 hours above its -18°C/0°F temperature threshold. The 0°C/32°F, 8°C/46°F, 20°C/68°F, and 25°C/77°F indicators have duration-of-excursion thresholds designed for 2, 12, and 48 hours. The highest threshold indicator, at 37°C/99°F, features duration-of-excursion spots that turn red after 0.5, 2, and 8 hours. Custom temperature thresholds also are available from SpotSee®.

Because WarmMark sensors are tamper-resistant, accurate, and irreversible, you know you can trust their results. These indicators provide irrefutable data that proves whether acceptable temperatures were maintained or whether they were exceeded, door-to-door, throughout the cold chain. With that data, you gain insights that can protect current shipments, prove proper handling, reveal temperature-related issues in your cold chain, and work proactively to remedy challenges before they can affect future shipments.

To activate the WarmMark label, simply fold-up and remove the clearly marked tab. Then simply affix this low-cost indicator label inside the shipping carton for time and temperature monitoring door-to-door.

These easy-to-use time and temperature indicators can be deployed anytime pharmaceuticals are shipped, at any point in the cold chain. For example, they can be used when shipping active pharmaceutical ingredients to a manufacturer, when shipping finished products to a distributor, and when shipping pharmaceuticals from a distributor to a pharmacy or healthcare provider. They also can be deployed in cartons of products that are on-site, waiting to be administered at mass vaccination sites.

Key Features of WarmMark:

  • Single-use
  • Time and Temperature Sensing
  • Changes Color When Specified Time Above a Threshold Temperature is Exceeded
  • Irreversible
  • Read-at-a-Glance
  • Activate by Folding

WarmMark helps you:

  • Gain visibility into sensitive shipments
  • Prove that shipments maintained safe temperatures, or
  • Spot products exposed to higher than acceptable temperatures
  • Extend quality control throughout your cold chain
  • Minimize wasted products
  • Protect patients from mishandled medicines
  • Provides irrefutable proof of handling conditions

Because the WarmMark time and temperature indicator turns red when specified temperatures have been breached, it’s easy to spot products that experienced high temperatures and to determine whether they remain safe and efficacious or whether they should be destroyed. Knowing the duration of exposure adds another layer of protection within the supply chain and can significantly reduce product wastage. Because WarmMark labels are irreversible, they provide concrete data to support immediate disposition decisions.

As pharmaceuticals become increasingly temperature sensitive, professionals must monitor cold chain and ambient temperature products closely. SpotSee’s WarmMark is a valuable tool that helps shippers can use to ensure pharmaceutical products reach their destinations while maintaining their optimum quality levels.

Globally, pharmaceutical regulators are becoming attuned to cold chain issues as biologics, vaccines and other temperature‐sensitive products are commercialised for a global clientele.
Delivering Covid-19 vaccines to 7.8 billion people is a daunting challenge that will stretch supply chains past their limits.
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