6 Degrees of Separation: -20°C and -40°C (Part 7)


Do you want a pizza, fifty frozen burgers, how about some test standards?  I knew you would go for the test standards!  Once again, we are back discussing temperature within the life science industry, and this time we are chatting about -20°C and -40°C freezer temperatures.

The -20°C and -40°C storage temperatures are important in storing drug product, raw materials, and test standards.  Each product has certain allowable storage temperatures in order to keep the product from degrading or losing its potency.  The following crucial steps should be considered when looking to purchase a laboratory grade freezer.

First, the user should define a set of user requirements for the units, which includes operating range and control accuracy.  There are many different manufacturers of laboratory grade freezers and each freezer has certain positives and negatives.  You should look at size of the freezer, electric control or manual control, and racking or shelves within the unit.

Once you have decided what you need, you will also expect to plan for validating that the unit you purchase to meet your planned user requirements.   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 for how to...click here!


Now that you have validated or qualified the freezer, you should install a monitoring system that can continuously monitor temperature while alerting users to any temperature deviations outside of the required parameters, -20°C and -40°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 the final post in this series of our temperature related discussions!


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