FREE TOOL · ICH Q1A(R2) MKT · PHARMA + FOOD PROFILES

Cold-Chain Excursion & MKT Calculator

Paste a temperature log. Get mean kinetic temperature, every excursion with duration and peak, and a verdict against the right standard.

COLD.CHAIN · MKTICH Q1A(R2) · RUNS IN YOUR BROWSER

MEAN KINETIC TEMPERATURE

— °C

Paste readings or load the sample.

Finding excursions after delivery is too late. Live alerts the moment a reefer drifts — temperature monitoring · instant quote.

Paste readings from any data logger (Testo, Elitech, LogTag, Sensitech, IOTee) — one temperature per line, or the raw CSV. Chart, MKT and excursion table appear here.

MKT & EXCURSIONS

How do you assess a cold-chain temperature excursion?

Count every reading outside the product's range and convert to time using the logger interval: a 2–8 °C vaccine log at 15-minute intervals with four readings above 8 °C has a one-hour heat excursion. Record the peak and duration of each excursion, then compare with the manufacturer's stability data — that decides release, not the average. Mean kinetic temperature (MKT) adds an Arrhenius-weighted single figure: MKT = (ΔH/R) ÷ −ln(Σe^(−ΔH/(R·Tᵢ))/n) with ΔH/R = 10,000 K; it is the release criterion for controlled-room-temperature products (must stay ≤ 25 °C per USP <659>) and supporting evidence for refrigerated ones. UAE food rules are simpler: chilled ≤ 5 °C, frozen ≤ −18 °C, discard chilled food that spent 4 cumulative hours above 8 °C.

Temperature profiles and standards

Ranges applied by the calculator. Last reviewed 2026-09-23.

Cold-chain temperature profiles, ranges and governing standards
ProfileRangeMKT limitStandard
Refrigerated pharma / vaccines2 to 8 °C—WHO TRS 961 Annex 9 / GDP: every excursion is assessed by duration against the product's stability data. MKT is supportive evidence only — it does not excuse a freeze or heat excursion.
Controlled room temperature15 to 25 °C25 °CUSP <659> / ICH Q1A(R2): MKT must not exceed 25 °C; spikes up to 40 °C lasting under 24 h are tolerated as long as MKT stays within limit.
Chilled food0 to 5 °C—Dubai Municipality Food Code: hold chilled food at 5 °C or below. Above 8 °C for more than 4 hours cumulative → discard.
Frozen food-40 to -18 °C—UAE / Codex: keep at −18 °C or colder. A brief rise to −15 °C in transit is tolerated; thawed product must not be refrozen.

MKT formula

MKT = (ΔH/R) / −ln( Σ e^(−ΔH/(R·Tᵢ)) / n ) − 273.15

ΔH = 83.144 kJ/mol (activation energy), R = 8.3144 J/mol·K, so ΔH/R = 10,000 K; Tᵢ = each reading in kelvin; n = number of readings. ICH Q1A(R2), USP <1150> and USP <659>.

Know about the excursion before the truck arrives

A logger tells you afterwards. A connected sensor tells the driver and the dispatcher while the door is still open.

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Link to this calculator so readers can check their own logger files:

<a href="https://iotee.ae/cold-chain-mkt-calculator/">Cold-Chain Excursion &amp; MKT Calculator</a>

Cold Chain & MKT — FAQ

Mean kinetic temperature (MKT) is a single temperature that would cause the same degradation as the actual fluctuating profile, because chemical degradation accelerates exponentially with temperature (Arrhenius). Per ICH Q1A(R2) and USP <1150>: MKT = (ΔH/R) ÷ [−ln( Σ e^(−ΔH/(R·Tᵢ)) ÷ n )], with ΔH/R = 10,000 K and Tᵢ in kelvin. It is always at or above the arithmetic mean; a few hot hours pull it up much more than the same number of cold hours pull it down.
No. MKT is defined for controlled-room-temperature products (USP <659>: MKT ≤ 25 °C, spikes to 40 °C under 24 h). For refrigerated pharma and vaccines, WHO TRS 961 Annex 9 and EU GDP require each excursion to be assessed against the product's stability data by duration and peak temperature — a freeze excursion of minutes can destroy an adsorbed vaccine regardless of MKT. Use MKT as supporting evidence in the deviation report, never as the sole release criterion.
The Dubai Municipality Food Code and Abu Dhabi Agriculture and Food Safety Authority require chilled food to be held at 5 °C or below and frozen food at −18 °C or below, with a tolerance of −15 °C briefly during transport. Chilled food above 8 °C for a cumulative 4 hours must be discarded. Refrigerated vehicles need a calibrated thermometer and temperature records available to inspectors.
Enter the interval your logger records at — commonly 5, 10 or 15 minutes for transport and 30–60 minutes for warehouses. Excursion durations are counted as readings × interval, so a 15-minute logger cannot resolve a 4-minute door-opening spike. Real-time telematics sensors report every 1–5 minutes and raise an alert on the first out-of-range reading.
Any text export: one temperature per line, or CSV/TSV rows where the last numeric column is the temperature (time,temp or date,time,temp,humidity all work). Testo, Elitech, LogTag, Sensitech, Tempmate, DeltaTrak and IOTee sensor exports have been tested. Up to 20,000 readings; nothing leaves your browser.

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