MORRIS PLAINS, N.J.--(BUSINESS WIRE)--In a study of six freeze indicators to determine accuracy and consistency FREEZEmarker®, a freeze indicator based on colloid science technology, outperformed competitive chemical indicators tested, and demonstrated equivalence or superiority to leading electronic indicators on all attributes tested. The results of the study, conducted by Micom Laboratories, were announced today by Temptime Corporation.
Freeze indicators play a very important role in the pharmaceutical cold chain. They are usually packed in boxes holding temperature sensitive vaccines, pharmaceutical and biologic products. There, they monitor temperatures and indicate whether there has been exposure to temperatures outside the specified range that may lead to freeze damage.
“Like all cold chain monitoring devices, freeze indicators are only as good as they are accurate and consistent,” said Michel Comtois of Micom Laboratories, an International Safe Transit (ISTA) Laboratory that conducted the independent testing. “Professionals all along the cold chain rely on these devices to indicate whether a freeze event has occurred. If it has, the product may be irrevocably damaged and should not be administered to patients.”
“The results of this study suggest that FREEZEmarker, the advanced colloid technology indicators, performed as well as, if not better than, electronic indicators,” he added. “They should be considered as cost-effective alternatives during the last mile, and for many other cold chain monitoring needs.”
Study Methodology and Overall Results
Twenty samples of six types of freeze indicators were tested to determine accuracy (performance against specification) and consistency. Of the six indicators tested, two were chemical indicators, two were colloid indicators, (two models of FREEZEmarker®) and two were electronic indicators.
The independent research was conducted at Micom Laboratories in Montreal, Canada, using a level of precision greater than the accepted industry standard (± 0.1°C versus ± 0.5°C).
All FREEZEmarker indicators responded within specification. One chemical indicator and one electronic indicator had data readings outside of the published product specifications, which when used in the field, could lead to false negatives. False negatives occur when a product is exposed to freezing temperature but the indicator fails to trigger. False negatives can lead to public health risks because patients may be administered a product that is freeze damaged and has lost potency.
The chemical indicator that did not meet specifications uses an indicating liquid. More than half -- 55% -- of the samples of this product failed to indicate when a freeze event occurred until they were placed at room temperature at the conclusion of the test, making it impossible to determine whether the device performed to specification in these instances. A similar performance in-field could be potentially harmful to public health unless receivers of the shipment took the time to allow the indicators to warm up to room temperature before making the decision on whether to use the product or not.
In the test, FREEZEmarker D demonstrated greater accuracy than one of the chemical indicators and greater consistency than both. Unlike one chemical indicator and one electronic indicator, both of Temptime indicators consistently performed within specification. In the test, both models of FREEZEmarker demonstrated greater accuracy than one of the chemical indicators and greater consistency (smaller standard deviation) than both. The FREEZEmarker type “D” also had greater or equivalent accuracy and consistency than both of the electronic indicators.
Performance in Sudden Freeze Situations
In this test, indicators were placed in an incubator at 20°C and then exposed to -23°C rapidly. A “sudden freeze” situation can affect the potency of temperature sensitive medicines. FREEZEmarker responded faster than all other competitors – both electronic and chemical. Neither of the electronic indicators responded within the set time - one at 10 minutes and the other at 15 minutes - when exposed to the sudden freeze situation.
About FREEZEmarker Technology
FREEZEmarker is a patented colloid indicator. The active substance is composed of extremely small particles of material that is evenly and stably distributed in a liquid. At a very precise temperature the small particles in the FREEZEmarker become unstable, overcoming the repulsive forces that keep particles separate, and allowing the coagulation that forms the opaque white color that shows a freeze event has occurred. Results of the FREEZEmarker indicator are irreversible.
About Temptime Corporation
Temptime, the world leader in time-temperature indicators, plays a vital role in the improvement of global heath by providing solutions that monitor temperature sensitive medical products. Temptime uses its patented technologies to develop and produce devices that provide definitive, irreversible readings while avoiding the environmental hazards associated with battery operated devices. To learn more about Temptime Corporation and its products, visit www.temptimecorp.com.