Temperature map for fridges and freezers

Temperature map and validation of refrigerators and freezers for storage of pharmaceuticals and thermolabile material.

To ensure appropriate storage conditions for drugs, vaccines and blood plasma, control authorities require validation of the temperature of the storage area. For this type of validation, the term temperature map of the space is also often used. The space in this case can be a classic refrigerator, a freezer or, for example, a larger chamber refrigerator or a room with cooling. By validating this space you can see if the implementation and cooling is efficient and meets the appropriate requirements. Measurements are performed in several different locations at a given time interval. The measurement results are then compiled into a validation protocol that meets the requirements of all inspection bodies.

• SÚKL (State Institute for Drug Control) - A temperature map is usually required for warehouses and refrigerators used for storing drugs and vaccines. In almost all cases a temperature map is required for the storage of blood and blood plasma. This is specifically addressed in document DIS-15 - Monitoring and control of temperature in the storage and transport of drugs. We have been performing temperature maps for the healthcare industry for nearly 15 years. That is why you will find our validation protocols in many hospitals and medical facilities and laboratories.
• BAXTER, GRIFOLS (blood plasma purchasers) - These companies also require appropriate storage of blood plasma, which they want to have again supported by validation of the storage area - temperature map. More information can also be found on the websites of these companies Baxter and Grifols.

We will share our experience

We have been performing temperature maps for almost 15 years and the experience we have gathered in that time is a lot. If you are currently dealing with a problem with a temperature map requirement, we will be happy to advise and explain everything. Our validation protocols for temperature maps have come a long way, which has been full of adjustments and fine tuning to ensure everything meets the legislative requirements.

The validation protocol contains all the elements.

In the validation report of the temperature map you will find all the data for a correct evaluation. It contains information about the customer and the measured equipment, the measurement method, i.e. the corresponding validation procedure, the standards used in the measurement, their calibration certificates and the relation of the standards to the national standard, the graphical layout of the sensors, and the photo documentation of the sensor layout in space, a graphical representation of the temperature progression in the equipment, a table with the measured values including statistics, copies of calibration certificates of temperature sensors that are calibrated in an accredited calibration laboratory, evaluation of the measurements, customer specific requirements, conclusion and evaluation of the customer requirements.

The validation protocol has undergone many adjustments and meets the legislative requirements.