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 - 1 008 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 QTA 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 Shelf-Life of a product varies depending on how the product is stored, transported and handled.
Tridentify's QTA Tracer System® that monitors temperature sensitive
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transfusion medicine, eliminates uncertainties whether the quality has been compromised or become unsuitable for use due to deterioration or loss of effectiveness.
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or pharmaceutical products, eliminates uncertainties whether the quality has been compromised or become unsuitable for use due to deterioration or loss of effectiveness. Tridentify's Shelf-Life Management function is based on stability data for the specific API, pharmaceutical or product being monitored.
The QTA Tracer System® triggers an alarm notification when the shelf-life has been consumed. Tridentify's Shelf-Life Management function is based on stability data for the specific pharmaceutical component or product being monitored.
Below is an example from our Web Portal.
