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I am sure that most of the Blog readers are familiar with MKT (Mean Kinetic Temperature) calculations, but just in case you are not, MKT is defined by the United States Pharmacopeia as:

"The single calculated temperature at which the total amount of degradation over a particular period is equal to the sum of the individual degradations that would occur at various temperatures".

The International Conference on Harmonization (ICH) stability testing guidelines defines MKT as:

"A single derived temperature which, if maintained over a defined period, would afford the same thermal challenge to a pharmaceutical product as would have been experienced over a range of both higher and lower temperatures for an equivalent defined period".

Even though most temperature data loggers have the ability to calculate this and offer it as a solution to evaluating temperature deviations from desired limits, or commonly called temperature excursions in cold chain jargon, some US based shippers of cold chain products are reluctant to accept this as a standard way of determining whether a product is within spec's and to determine, the stability, efficacy and safety of the medicinal products.

However the trend in other regions of the globe, like the EU, is that they are starting to embrace this approach for determining safety, quality and the efficacy of these products.

There also seems to be some confusion in some quality circles as to the number of decimal places that the this value should be calculated down to. From my experience I have seen one and perhaps two places in some circumstances (test labs' for example), but usually not more than this.

The report that is provided by DeltaTrak as part of the logger PDF report provides the calculation to one decimal point which I believe is the common standard within the industry.

Would certainly like to have some feedback on this from the readers, if possible to confirm these details.

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Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

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