Humidity and temperature mapping
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!
Temperature mapping is a study, where the temperature distribution within an area is studied, documented and analysed.
For applications that are subjected to the GxP quality guidelines within regulated industries, mapping is essential to decide where, within an area, testing, production, storage and distribution can be carried out based upon a scientific risk-based assessment, using the results from a mapping study. Further to a mapping study, the design of an area may be improved or simply blocked off for any GxP purpose. Environmental monitoring systems can be installed to ensure that the area complies to the defined temperature limits to ensure patient safety.
Various guidelines exist as to why temperature mapping is required and how it should be carried out:
Influencing factors considered during mapping
- WHO Technical Report Series, No. 961: Temperature mapping of storage areas.
- EU Guidelines in Good Distribution Practice of medicinal products for human use.
- Good Manufacturing Practices: Temperature Mapping of Controlled Temperature Chamber.
- FDA 21 CFR various chapters.
- USP1079.
- ICH Topic Q 1 A (R2) Stability Testing of new Drug Substances and Products.
- PDA Technical Report 39: Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment.
Some of the main points to consider when defining the mapping protocol, the acceptance criteria and the products used to carry out a mapping:
- Comply to FDA 21 CFR Part 11.
- 60 second to 15 minute log interval.
- ISO-17025 traceable 3 point calibration with a guaranteed error no more than a ±0.5°C at each calibration point.
- Monitor door openings and power outages.
- Show minimums, maximums, average, standard deviation and mean kinetic temperature.
- Summer /winter mapping and loaded/empty/normal conditions.
- Requirement to map relative humidity/dew point.
Rotronic can offer mapping hardware:
Rotronic offers a range of USP 1118 monitoring devices for time, temperature and relative humidity.
| Temperature | Relative Humidity | Dew Point | ||||
|---|---|---|---|---|---|---|
| TL-1D with the HW4 software | ±0.3 °C | |||||
| HL-1D with the HW4 software | ±0.3 °C | ±3.0 %RH | ||||
| RMS-LOG-L/868/915 with RMS software | ±0.1°C | ±0.8 %RH | ||||
| Optidew and RMS-LOG-T30-L/868/915 with RMS software |
±0.1°C | ±0.15°C | ||||
- 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
Rotronic can offer mapping services:
- Support with the definition of the protocol and the area acceptance criteria.
- 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 GxP-compliant documentation.
- Recommendations for optimization.
Rotronic can offer rental mapping services:
Rotronic also offers the possibility to rent an RMS and a partnership solution, where we will work with you on all phases on the project:
- Using the standard Rotronic setup and documentation.
- Using RMS hardware with Traceable calibration performed quarterly at standard points (0, 23, 50°C).
- Additional costs for additional calibrations as per customer requirements.
- Access to RMS Mapping Cloud account.
- Optional 4G router for live data during mapping (dependent on wireless, requires mains power).
- Evaluation and analysis of the recorded data.
- Preparation of GxP-compliant documentation.
- Recommendations for optimization.
Simply place the loggers in the defined areas for the defined amount of time and return them to Rotronic.
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