Validation & Qualification

Temperature Mapping

What a definition is not

A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.

A study that places calibrated data loggers throughout a storage space, chamber, or transport unit under defined loading and door-opening conditions to characterize its spatial and temporal temperature — and often humidity — profile, identifying hot or cold spots and confirming the space consistently holds its specified range.

Logger placement follows a documented rationale rather than guesswork — typically the corners, center, and near the door of the space, since those locations are most likely to reveal the extremes of a temperature distribution. Mapping is usually performed both empty and at maximum defined load, since airflow and thermal mass change significantly between the two conditions.

The results of the mapping study are what determine where routine, continuous monitoring probes are ultimately placed — the map identifies the worst-case locations, and ongoing monitoring is set up to watch exactly those spots going forward.

KEY POINTS
  • Logger placement is based on a documented rationale, commonly corners, center, and door locations
  • Performed at both empty and maximum-load conditions, since these differ significantly
  • Determines where routine continuous-monitoring probes are subsequently installed
  • Repeated periodically or after any change to the space, its load pattern, or its HVAC system
REGULATORY BASIS

WHO Technical Report Series 961, Annex 9; USP <1079>; EU GDP Guidelines (2013/C 343/01)

Frequently asked questions

What is Temperature Mapping?

A study that places calibrated data loggers throughout a storage space, chamber, or transport unit under defined loading and door-opening conditions to characterize its spatial and temporal temperature — and often humidity — profile, identifying hot or cold spots and confirming the space consistently holds its specified range.

Which regulations cover Temperature Mapping?

WHO Technical Report Series 961, Annex 9; USP <1079>; EU GDP Guidelines (2013/C 343/01)