6 Degrees of Separation: 2 - 8°C (Part 3)


2-8°C of Separation

When we think of 2-8°C, we automatically think of our household refrigerators which keep our groceries fresh and our beer cold. However, in the life sciences industry, fridges keep the ideal, stable temperature for everything from integral and important testing standards to products and raw materials. In order to keep these integral products, raw materials and test standards safely stored, companies need to purchase, validate, and continuously monitor their fridges.

If you are considering the purchase of laboratory-grade storage fridges, you should first develop a clear list of user requirements. This includes operating range and control accuracy of the unit. Other physical factors like wire racks versus glass racks and the number of racks or size of the unit should be taken into consideration during research. Once you have determined your needs, you should plan to validate the unit you purchase to meet your documented user requirements needs. A thermal validation mapping of the unit initially confirms and verifies that the unit complies with specifications and data sheets provided by the manufacturer. After the initial qualification, the unit should have its performance verified annually to ensure it continues to perform within the expected parameters. We have written a brief guide on validation mapping, entitled Implementing Successful Mapping Solutions. Click here to read the whitepaper.


Now that you have validated or qualified the fridge, you should install a monitoring system that can continuously monitor temperature while alerting users to any temperature deviations outside of the required parameters, 2-8°C in this case.  The monitoring system should have an FDA 21 CFR Part 11 compliant software package that is user friendly to secure your recorded temperature data for regulatory purposes.

Tune in next week for our discussion about ultracold -80°C temperatures.


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