DeltaTrak®, a leading manufacturer of cold chain management solutions and life science products has increased production of all products that help ensure product efficacy for vaccines and pharmaceuticals. All these products are designed to monitor and record temperature, and can be used during transport and/or storage of vaccines and pharmaceuticals.
Many vaccines and pharmaceuticals have temperature sensitivity where they must be kept between 2° and 8° centigrade. If temperature limits are exceeded, these chemicals change to where they lose potency. It is vital that professionals who are administering these preventative drugs know they have not been exposed to temperature abuse.
There are four primary categories of products that DeltaTrak provides for the life sciences industry that meet FDA 21 CFR Part 11 compliance. All of these products are used by pharmaceutical companies with the goal of product efficacy.
For the transportation and temporary storage of vaccines, DeltaTrak offers the FlashLink CT BioLogger, an electronic data logger with preset temperature alarm limits at 2 and 8 degrees centigrade. These data loggers include ShadowLog®, a feature that guarantees temperature data is collected even if an operator fails to start the device.
Strip chart recorders are a very cost effective solution for monitoring temperature during transportation. They provide temperature history information without the need for any external data extraction system.
Time and temperature labels provide a visual yes/no verification of the cumulative temperature abuse value in degree minutes by showing an irreversible color change. Models are available at the 8°C temperature threshold.
Certified glycol min/max thermometers are used in refrigerators and can be programmed to sound audible alarms when temperature limits are exceeded. Because the sensor is surrounded by a glycol solution, they are not susceptible to ambient temperature changes when the door is opened and closed.