Measuring room temperature and humidity

In the rules on the system for the reception, storage and traceability of medicinal products (Art. 82/2015) in the 4th and Article 5 states the conditions for storage of medicines and that the temperature and humidity in the rooms must be regularly monitored, documented and controlled. In this respect, it is essential to regularly measure the temperature and humidity in the room.

In the Official Journal of the European Union (2013/C 68/01, March 2013) state that the temperature in the premises must be kept within acceptable limits (point 3.1); that before the storage area is used, it must be subjected to validation (mapping) within representative boundaries, and to fit small spaces temperature monitoring devices (point 3.2.1); adequate records of repairs, maintenance and calibration of key equipment must be kept and the results retained – humidity and temperature gauges or others temperature and humidity recording devices (point 3.3); that medicinal products which must be stored at a certain temperature, for example low temperature, may only be returned to the sales stock, where there is documented evidencethat the medicinal product has been stored at all times under approved storage conditions (point 6.3); the trader is responsible for ensuring that temperatures during transport are maintained within acceptable limits (point 9.1); the equipment for monitoring the temperature during transport in vehicles and/or containers must be maintained and regularly – calibrated at least once a year (point 9.2)

But how can we regularly monitor, document and control room temperature and humidity?

Measuring room temperature and humidity is now possible with a data logger or memory unit from our partner EBRO, which can simultaneously measure, store and monitor the temperature in your room.

No more manual inventories!

There are several different loggers to choose from, the most popular being the EBI 20-TH1 and the EBI 300-TH.

Of course, there are more options for data loggers, such as WiFi systems, radio systems, etc.

See also the following brochures for more information:

• Cold chain monitoring _ following GXP and FDA guidelines
• USB dataloggers for cold chain monitoring

Author Barbara Čičak
November 2020