CleanroomProcesses

17.04.2023
Bearing mapping made by BRIEM
Briem Steuerungstechnik GmbH

Mapping of rooms and devices in the GDP environment

Numerous guidelines describe the need for temperature mapping before using rooms or devices for storing medicinal products. The term "mapping" refers to a documented measurement of the ambient conditions of storage rooms. It is also referred to as a "temperature distribution study" (EU-GDP guidelines).
In addition to the actual measurement, an important component of mapping is the evaluation and analysis of the measurement data. This means that mapping can be used to create a "thermal image" of the warehouse and thus prove that the rooms are suitable for storing the pharmaceuticals.
During mapping, numerous measuring devices record the climate data at previously defined measuring points over a specified period (e.g. 7 days). Based on the evaluation of the measurement data, the critical measurement points can then be analyzed (cold spot = coldest point, hot spot = warmest point, average warmest/coldest point...). These points are then the correct measuring points for permanent monitoring.

BRIEM is your competent partner when it comes to mapping. We support you throughout the entire process. Our package includes everything you need, from the initial consultation through to approval by the authorities.

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