cGMP Mapping Service

 cGMP Mapping Service

Incorrect temperature or humidity measurements can result in expensive damage to products. This must be avoided under all circumstances and steps taken immediately in the case of unintended changes in climatic conditions!

However, before an FDA-compliant system can be installed, it is first necessary to investigate where and how many measuring points should be set up to monitor the production or storage rooms. This is done with the help of a temperature and humidity mapping procedure. This mapping provides information on how many temperature zones (temperature gradients) there are in the rooms. Using the measured data, it is possible to define the optimum storage places for products or, in the extreme case, to initiate changes in the room climate!. Mapping also takes influencing factors such as direct sunlight, air conditioners, insulation, heat sources, outside temperature, into consideration, resulting in recommendations on how to optimize conditions if applicable.
Mapping is typically performed at very hot and very cold times of the year. The period of measurement analysis is about one to two weeks. A generous number of measuring points are used to ensure that every zone is covered.
We recommend renewed mapping if a production or storage area is modified or if there are other significant changes to the room.

Mapping by ROTRONIC comprises:

  • Analysis of the requirements and definition of the measuring points
  • Placement/Installation of the data loggers with traceable certificates
  • Continuous recording of the climatic conditions
  • Evaluation and analysis of the recorded data
  • Preparation of GMP-compliant documentation
  • Recommendations for optimization from ROTRONIC

Your benefits:

  • Exact data on room climate
  • FDA conformity
  • Knowledge of possible problem areas