Shelf-life Management
Safely measures temperature and condition throughout the life cycle of biological & pharma products
Shelf-Life Management - based on stability data
​
QTA Tracer System® is a sensor-based, real-time temperature monitoring system that reduces the uncertainty of temperature fluctuations on pharmaceuticals, vaccines, blood, plasma, biologicals and other products throughout the cold chain, from donor to recipient or from manufacturing to patient.
​
Any deviation in temperature is logged and time-stamped. The information is used to continuously calculate the remaining shelf life. It facilitates the analysis of data and delivers confidence in the cold chain process. The advanced algorithm used can be customized to a specific product or an organization’s specific requirements and saved as a user configured profile.
How the QTA Tracer continuously calculates shelf-life in real time
Tracer settings are configurable to meet your needs and comply with national or local regulations.
It would be the easiest thing if blood was always stored and transported at the same temperature.
Then you would know that blood stored at 4°C would be valid for 35 or 42 days - 1008 hours in the latter case. But the reality is that the blood will be exposed to many different temperatures during its lifetime.
The QTA Tracer (MDD MedTech Device Class IIa*) recalculates the "remaining shelf life" in real-time, - adjust the expiration date - for the blood at each log. If the tracer is configured to log every minute, the expiration date will be adjusted every minute. You don't have to guess how much life has been lost when the blood has been exposed to 14°C for two hours. The Tracer does that for you with accuracy, in real-time.
*MDD Certificate extended to end of 2028 due to Article 120 of MDR
Shelf-life management
The lifespan of a product is usually not affected by a single short temperature peak. Using a modern temperature logger, it only indicates that a pharmaceutical, vaccine, blood, plasma, biological or other product has exceeded a set temperature limit which many times results in the product being discarded.
​​
With QTA Tracer System® you can allow short temperature peaks. The system will only trigger alarm when Shelf-Life is consumed. You can also always set max/min temp that product are not allowed to exceed.
The Shelf-Life management function is based on stability data for the specific pharmaceutical, vaccine, blood, plasma, biological and other product being monitored.