Cold room temperature mapping
Walk-in cold rooms combine forced airflow, door traffic and defrost cycles — each leaves a signature in the data.
A 2–8 °C cold room is small enough to map thoroughly and busy enough to surprise you. Typical gradients run from the evaporator outlet (coldest, sometimes below 2 °C) to the door and the top shelves furthest from the airflow.
Placement
- Corners at low and high level, the geometric centre, directly in front of the evaporator, and beside the door.
- Product height, not the ceiling: sensors should sit where product actually sits.
- One sensor outside the room as an ambient reference helps explain door-related events.
What to expect in the data
Defrost cycles show as periodic rises at the evaporator sensor; door openings as short spikes near the door that recover within minutes. Neither is necessarily an excursion, but both must be assessed against the limits and durations in the protocol. Run the study for several days so that daily patterns and weekday deliveries are captured.
Reading the three signatures in the data
Almost everything interesting in a cold-room dataset is one of three patterns, and telling them apart is most of the analysis.
| Pattern | Where it appears | Cause |
|---|---|---|
| Regular rises every 6–12 h, 15–45 min long | Evaporator sensor most strongly; others muted | Defrost cycle |
| Sharp spike, recovery in 5–20 min | Sensors near the door | Door opening |
| Slow rise over hours, all sensors together | Whole room | Warm goods in, or plant struggling |
| Sawtooth of 0.5–1.5 °C, continuous | All sensors | Normal control cycling |
| One sensor drifting away from the rest | One position only | Sensor fault, or something physically changed at that position |
Defrost and door events are not automatically excursions, but they are not automatically excusable either. Both get assessed against the limits and durations the protocol set, and both need the ambient reference sensor to interpret: a rise at the door sensor that coincides with nothing outside is not a door opening.
The evaporator, which is the cold spot
In a 2–8 °C room the freezing risk is real and it is directly in the evaporator discharge, where air leaves several degrees below the room set point in order to average out to it. Product stacked in that airflow can sit below 0 °C while the room reads 5 °C, and for vaccines and biologicals that is an irreversible loss that no averaging will show.
So one sensor goes directly in the discharge, deliberately, and the report says what it found. If that position is below the lower limit, the answer is an exclusion zone — marked physically, not just in a document — or a deflector, not a wider acceptance criterion.
Duration and timing
- Run at least 72 hours so that several complete defrost cycles are captured. A 24-hour study may see one, or none, and cannot show whether they are consistent.
- Include a normal working day with real door traffic. A weekend study characterises a room nobody is using.
- Log every 1 to 5 minutes. Door events are short, and a 15-minute interval can put a whole excursion between two readings.
- Place one sensor outside the room. It costs one logger and explains most of the features above.
- Let sensors equilibrate before the study clock starts — a logger carried in from a 20 °C corridor takes time to settle, and the first hour will otherwise look like a warm spot.
Frequently asked questions
- How long should a cold room mapping study run?
- Several days, long enough to include weekday deliveries, a weekend and multiple defrost cycles — commonly five to seven days.
- Where is the cold spot in a cold room usually?
- Directly in the evaporator air stream, where product can be exposed to sub-2 °C air; the hot spot is usually near the door or on the top shelf furthest from airflow.
References
- [1]WHO Technical Supplement 8 to TRS 961 Annex 9: Temperature mapping of storage areas (2015)
- [2]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.
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