What is temperature mapping?
Why regulated storage spaces are mapped, what a study produces, and how the results are used.
Temperature mapping is a documented study that characterises how temperature is distributed across a storage or process space over time. Calibrated sensors are placed at defined locations, data is recorded for a defined period, and the results are analysed to find the warmest and coldest locations, to check that the whole space stays within its acceptance limits, and to decide where routine monitoring sensors should go.
Why it is done
A single monitoring probe only tells you the temperature at one point. Airflow, door openings, shelving, lighting and equipment all create gradients, so the product on a top shelf near a light fitting can experience a different environment from the product beside the evaporator. Mapping gives evidence that the space, as used, is capable of holding product within its label conditions — which is why guidance for the storage of temperature-sensitive pharmaceutical products asks for it.
What a study produces
- A protocol: purpose, acceptance limits, sensor locations, duration, loading condition, sampling interval.
- Sensor calibration evidence, so that readings are traceable.
- The raw data set and a data-quality assessment (gaps, duplicates, sensor faults).
- Statistics per sensor and overall: minimum, maximum, mean and spread.
- Identified hot and cold spots and any excursions, with duration and magnitude.
- A report with findings, limitations and recommended monitoring locations, reviewed and approved by a responsible person.
How the results are used
The hot and cold spots become the locations for permanent monitoring. Excursions drive corrective actions such as airflow changes, re-zoning of shelving, or exclusion of an area from storage. The study is typically repeated after significant changes and at a defined interval, and often under both empty and loaded conditions, and across seasons where ambient conditions matter.
ValiTrac's mapping engine implements the analysis part of this workflow — data quality, statistics, hot/cold spots, excursions and a draft report — behind an explicit human review gate. It does not replace the protocol, the calibration of the sensors or the reviewer's judgement.
Frequently asked questions
- What is the purpose of temperature mapping?
- To demonstrate with data that a storage space, as used, keeps product within its label storage condition everywhere — and to find the worst-case locations where monitoring sensors should go.
- How long does a temperature mapping study take?
- Typically 24–72 hours for a refrigerator or small chamber and several days to a week or more for a cold room or warehouse, so that daily cycles, deliveries and defrost events are captured.
- Is temperature mapping a regulatory requirement?
- EU GDP requires an initial mapping of storage areas before use and re-mapping after significant changes; GMP Annex 15 expects it as part of qualifying temperature-controlled equipment and areas.
References
- [1]WHO Technical Report Series 961, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (2011)
- [2]WHO Technical Supplement 8 to TRS 961 Annex 9: Temperature mapping of storage areas (2015)
- [3]EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
Have a question on this topic?
Ask ValiTrac AI and see the evidence and calculation behind the answer.
Ask ValiTrac AIFree calculator: MKT & logger data check
Paste logger readings and get MKT per ICH Q1A(R2) alongside min, max, mean and out-of-limit runs with durations.
Open the calculatorTemperature Mapping on ValiTrac
Analyse logger data and identify data-quality issues, statistics, hot/cold spots and excursions.
Explore mappingRelated articles
How many sensors are needed for temperature mapping?
There is no single number: sensor count follows from the geometry, the risk points and the acceptance limits of the space.
How to identify hot and cold spots
Hot and cold spots are defined by the data and the limits together — and the definition should be fixed before the analysis starts.