Mean Kinetic Temperature (MKT) is a single calculated temperature that summarises the cumulative effect of the temperature variations a product was exposed to over a period. It’s not a simple average: it weights higher temperatures more heavily, because their impact on stability is greater.
What it’s for
In the pharmaceutical cold chain, MKT lets you assess the overall thermal stress a batch has undergone, even with brief temperature excursions. If the MKT stays within limits, the cumulative exposure is considered acceptable despite point fluctuations.
How it’s used
It’s calculated from data-logger readings over time (Arrhenius equation). It’s an assessment tool foreseen by quality practices (GDP) to decide on a product’s compliance after temperature deviations, in a scientifically defensible way.
FAQ
What’s the difference between MKT and a simple average?
The arithmetic mean treats all temperatures equally; MKT weights higher temperatures more, reflecting their real impact on product degradation.
Does MKT replace excursion control?
No. MKT assesses cumulative exposure, but individual serious excursions must still be recorded and managed under GDP procedures, regardless of the overall MKT.