Temperature Mapping, Temperature Distribution Study for GxP Applications

Mapping data can be the base to initiate changes to room air conditioning.



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Temperature mapping is a GxP service that analyses and documents the climatic conditions in a (storage) room.

The purpose of the analysis is to show where temperature-sensitive pharmaceuticals, life science products, food, etc. should be stored and where not. The thermal qualification of storage environments ensures that products meet the quality requirements and the required guidelines (FDA CFR 21).

The temperature distribution study (mapping) is conducted according to USP1079 (Good Storage and Shipping Practices) and the results are handed over to the customer with a compliant mapping report.

Why is a Mapping valuable?

With the knowledge gained from the mapping, the customer is able to contract any necessary modifications to the HVAC system, store products correctly according to their storage conditions and thus avoid costly damage to temperature-sensitive products.Although most mappings refer to temperature, this also applies to relative humidity under the given circumstances.


What makes a mapping successful?

Experienced qualification engineers determine the application-specific requirements. Risk areas are identified, and a test plan developed for the temperature study. The climate data are collected with Rotronic temperature and humidity loggers. The measuring instruments are calibrated in a traceable manner and the certificates handed over to the customer before and after the temperature distribution study.

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