Dual Heat and Freeze Indicators
Range of Products
Product Implementation Support
|Click image for a product demo
Risk of Product Damage Increases Through the Cold Chain
The risk of undetected heat damage is greatly increased as heat-sensitive products move through the cold chain. The controls followed by the manufacturer and distributors may not be maintained during shipping, at storage points, in physician offices, and by patients. See Independent Physician Research
HEATmarker® Monitors from Manufacture to Patient Administration
HEATmarker is a miniaturized, self-adhesive indicator that is affixed by the biologic or pharmaceutical manufacturer to individual units of temperature sensitive medical products (vials, syringes, etc.) to monitor storage and handling of products until the time of use. The square portion of the indicator contains a color changing material that progressively and irreversibly darkens as the product is exposed to temperature over time.
HEATmarker can be Correlated to the Heat Stability of the Individual Product
HEATmarker develops color in the same way many biologics, pharmaceuticals, and devices degrade as they are exposed to heat - faster at higher temperatures and slower at lower temperatures. HEATmarker accumulates all of the temperature conditions experienced by the product to which it is affixed. When the color of the square matches or is darker than the surrounding circle, the HEATmarker indicator is showing that the product has been exposed to potentially damaging heat.
Temptime produces more than 20 different standard categories of HEATmarker that monitor a wide range of mean kinetic temperature profiles from days at refrigerated temperature to nine years at 27°C.
Value for Healthcare Professionals and Manufacturers
A HEATmarker on each unit of a temperature sensitive medical product can:
- Avoid administration of heat damaged medications to patients by clearly showing whether or not the product has been exposed to excessive heat.
- Support Call Center efforts – provide definitive information about potentially heat damaged products to healthcare professionals and patients.
- Enhance quality risk management and support continual quality improvement.
- Strengthen conformance to International Code on Harmonization (ICH) Q9 and ICH Q10.
- Reduce unnecessary waste – limit the destruction of products incorrectly suspected of heat damage.
The HEATmarker Supports Global Effort to Save Lives
Major vaccine manufacturers worldwide have used more than 3 billion HEATmarkers for vaccination campaigns sponsored by the World Health Organization (WHO), Global Alliance for Vaccinations and Immunization, and the governments of India, Indonesia and Pakistan. A joint study by the WHO and PATH showed that in 2006 HEATmarker:
- Identified more than 23 million doses of vaccine that were damaged by heat and therefore were not administered to children; and
- Identified more than 31 million doses of vaccine that were exposed to potentially damaging heat, but were still effective for use – Avoiding waste of those vaccines.
The WHO estimates that over the next 10 years, HEATmarker will enable the delivery of an additional 140 million doses of vaccine, saving 140,000 lives and decreasing the morbidity rates for countless others.