Calculate Mean Kinetic Temperature (MKT) for a completed cold-chain shipment to determine cumulative thermal exposure for pharmaceutical product disposition

Steps

1. Retrieve all temperature readings for the shipment from the logger telemetry store, sorted by reading timestamp; verify complete temporal coverage by checking for sequence gaps against the logger's programmed recording interval
2. Apply the MKT formula defined in WHO Technical Report 953 (2009): MKT = (-ΔH/R) / ln[(1/n) * Σ e^(-ΔH/R*Ti)], where ΔH is the activation energy (default 83,144 J/mol for pharmaceutical use unless product-specific data available), R is the gas constant 8.314 J/mol/K, Ti is each reading in Kelvin, and n is the number of readings
3. Convert each Celsius reading to Kelvin by adding 273.15 before applying the exponential; perform the summation in floating-point with sufficient precision to avoid rounding error across thousands of readings
4. Compare the computed MKT against the product's labeled storage condition mean temperature (commonly 15°C for controlled room temperature per USP <659> or 5°C for refrigerated); if MKT exceeds the limit, flag the lot for disposition review
5. Store the MKT result with inputs: shipment ID, logger device IDs used, reading count, time span covered, activation energy used, and computed MKT in Celsius; include this record in the chain-of-custody document package
6. Generate an exceedance report if MKT is out of specification: include the distribution of readings across temperature bands, duration at each band, and the highest single excursion temperature and duration for QA decision support