Termodensirom · Certification for pharmaceutical storage
75 mapping points.
Temperature and humidity, recorded every 15 minutes, for a minimum of 7 days.
Zone I. 48 sensors.
Depozitare I / Repaletizare · Coridor
Zone II. 27 sensors.
Depozitare II
Three levels.
0.5 m · 4.5 m · 9.0 m
One reference, outdoors.
North face. Natural environment.
Every degree,
accounted for.
We instrument the room.
Before a warehouse holds medicine, it holds a temperature. We place calibrated sensors through the full volume of the space — floor to nine metres — and listen for seven days.
15–25 °C. ≤ 70% RH.
The acceptance band. Every reading answers to it.
Degree by degree.
Measured values, 16.2 – 20.0 °C — inside the band, wall to wall. Scroll: the plan replays the seven days of the study.
Then the room is drawn — as a map of its own temperature.
Calibrated. Certified.
On file.
TZone TZ‑Temp U03 data loggers. Every unit calibrated, every certificate annexed to the report.
- Temperature range
- −30 … +60 °C
- Accuracy
- ± 0.5 °C
- Humidity
- 0 … 85% RH, ± 3%
- Resolution
- 0.1 °C
- Memory
- 32,000 records
- Calibration
- Renewed yearly
Two documents.
Every number.
Raportul de Mapare and Raportul de Calificare de Performanță — the record a regulator opens first.
- Sensor placement drawings
- Calibration certificates
- Exterior reference temperatures
- Recorded curves, every point
- Temperature maps
- Conclusions & recommendations
- Permanent monitoring points
Frequently asked questions.
What is temperature mapping of a pharmaceutical warehouse?
A study that measures temperature and humidity through the full volume of the warehouse, to demonstrate, in line with Good Distribution Practice (GDP), that the space stays within 15–25 °C and at most 70% relative humidity. The number of sensors depends on the size and height of the warehouse — it can be higher or lower; the 75 points on three levels, from 0.5 to 9 metres, are the example of one particular warehouse.
How long does a mapping study take?
A minimum of 7 days of continuous recording, with readings every 15 minutes — over 50,000 measurements per study — followed by the preparation of the reports.
What documents do I receive?
The Mapping Report and the Performance Qualification Report: sensor placement drawings, calibration certificates, the recorded curves point by point, temperature maps, conclusions and the recommended permanent monitoring points.
What instruments are used?
TZone TZ‑Temp U03 data loggers — ±0.5 °C and ±3% RH accuracy — calibrated yearly; every calibration certificate is annexed to the report.