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| MKT Datalogger | ||
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Mean Kinetic Temperature (MKT) is a simplified way of expressing the overall effect of temperature fluctuations during storage or transit of perishable goods. All our MadgeTech temperature dataloggers will generate MKT values from data collected in any environment from -200°C to + 400°C. |
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| MKT is expressed as: |
ΔH = activation energy (typically from 60 to 100 kJ/mol for solids and liquids) |
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| OVERVIEW: | ||
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Technically speaking, MKT is an expression of cumulative thermal stress experienced by a product at varying temperatures during storage and distribution. In other words, MKT is a calculated, single temperature that is analogous to the effects of temperature variations over a period of time. MKT is not a simple weighted average. The calculation of MKT gives the higher temperatures a greater weight when computing the average than would a simple numerical average or an arithmetic mean. This weighting is determined by a geometric transformation--the natural logarithm of the absolute temperature. The International Conference on Harmonization (ICH) stability testing guidelines define 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’. By using this unequal weighting of the higher temperatures in a temperature series, MKT takes into consideration the accelerated rate of thermal degradation of materials at these higher temperatures. Therefore, MKT provides for the non-linear effect of temperature. |
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| WHY IS MKT IMPORTANT IN THE LIFE OF PHARMACEUTICALS AND PERISHABLE GOODS? | ||
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The pharmaceutical and food industries are two closely regulated markets. The FDA provides regulations that require warehouse and shipment temperatures to be closely controlled and monitored. In addition, the FDA requires well documented verification of these storage environments and any corrective actions taken if temperatures exceed specified storage conditions. The calculation of MKT is regarded by the FDA as an action taken to verify if a particular perishable has exceeded storage conditions. In addition to compliance with the FDA regulations, MKT can help Distributors and Manufacturers determine if improper storage or handling of goods that might have occurred during shipment and/or unloading, has affected the shelf life of the product.
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| HOW DOES MADGETECH MAKE MKT SIMPLE? | ||
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MadgeTech’s software automatically calculates MKT for any of our temperature loggers as shown in the summary report. The MadgeTech algorithm has been validated against the United States Pharmacopeia (USP) and will yield a value within 0.1 °C for all inputs. It is also important to note that the MadgeTech software uses constants that are more recent and marginally more accurate than the USP. MadgeTech obtains these constants from the CODATA / NIST recommended values available at http://physics.nist.gov/cuu/Constants/. The software assumes activation energy of 83.14472 kJ/mol for its calculation. In fact, any value between 60 and 100 kJ/mol, which covers most solids and liquids, will have only a small effect on the final value. Of course, extreme temperatures even over a very small time period can damage most foods or pharmaceuticals. Per the above example, putting an egg in a 75º C oven for 1/2 hour will bring the MKT to 45.4º C, but the egg will be irreversibly damaged (i.e. cooked). Consequently, there are maximum and minimum temperature limits established by the FDA. |
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