Temperature mapping studies
Mapping studies for temperature-controlled units such as chambers, refrigerators, freezers, and incubators, plus seasonal summer and winter studies for warehouses.
Why mapping matters
A single display reading does not show what your product experiences on the top shelf by the door. A mapping study places calibrated sensors throughout the space to document temperature distribution, find the hot and cold spots, and confirm the unit holds its range in use.
The results tell you where to place the permanent monitoring probes and give you evidence that storage conditions are controlled.
How we run a study
Each study follows an approved protocol with a justified sensor layout, pre- and post-study calibration verification, and defined acceptance criteria. Where the risk warrants it, we add door-open and power-failure recovery tests and run both empty and loaded conditions.
Warehouses are mapped in summer and winter to capture seasonal extremes. We work with Kaye Validator AVS, Ellab, and DataTrace systems.
What we deliver
- Mapping protocols with sensor placement rationale
- Empty and loaded chamber studies
- Door-open and power-failure recovery tests
- Seasonal summer and winter warehouse studies
- Sensor calibration verification
- Summary reports with hot and cold spot analysis
- Monitoring probe placement recommendations
Regulations and standards
- 21 CFR 211.142 and 211.150
- USP <1079>
- ISO 22716
- ICH Q1A storage conditions
Common questions
How often should temperature mapping be repeated?
Remap on a risk-based schedule and after any change that could affect temperature distribution, such as a relocation, a major repair, a change in load pattern, or a modification to the HVAC or refrigeration system.
How many sensors does a mapping study need?
It depends on the size and geometry of the space. A small chamber commonly uses sensors at the corners and center, while a warehouse needs a three-dimensional grid that covers racking heights, doors, and areas near heat sources. The layout is justified in the protocol.
Why map a warehouse in both summer and winter?
Outdoor conditions change how the building and its HVAC behave. Seasonal studies show the space stays within range at both extremes.
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Whether it's a single qualification or an audit on the calendar, send a few details and we'll reply within one business day.