Formule MKT 2

What is Mean Kinetic Temperature (MKT)?

Mean Kinetic Temperature (MKT): A Scientific Explanation

What is Mean Kinetic Temperature (MKT)?

Mean Kinetic Temperature (MKT) is a calculated value that estimates the overall impact of temperature variations on temperature-sensitive products during storage and transportation. In other words, MKT represents an equivalent average temperature that simulates the effect of temperature fluctuations on a product over its lifecycle, taking into account not only the extreme temperatures but also the duration of each exposure.

MKT is particularly used in industries such as pharmaceuticals, biopharmaceuticals, food, and other sectors where products are sensitive to temperature changes. These products can undergo chemical or physical alterations due to temperature fluctuations, compromising their quality, effectiveness, or safety. MKT provides a better understanding of the global thermal impact on these products, even if the actual temperature varies over time.

Why is MKT Important?

MKT is a valuable indicator in evaluating the integrity of temperature-sensitive products. Unlike simple average temperature, which does not account for temperature variations or their duration, MKT takes into consideration the cumulative effect of temperature fluctuations, assigning more weight to periods of higher temperatures, which are generally more damaging to the products.

This indicator helps manufacturers, distributors, and regulators determine if a product has been exposed to temperature conditions that could affect its characteristics (such as stability, effectiveness, or safety) during transport or storage. Moreover, in industries dealing with products like medications, vaccines, or perishable goods, MKT provides a reliable method to ensure that products remain within required temperature ranges throughout their supply chain.

How to Calculate MKT?

The calculation of Mean Kinetic Temperature involves using a formula that combines measured temperatures at various times and the duration of exposure to those temperatures. The standard formula used to calculate MKT is as follows:

where:

  • T_i is the temperature measured at time i (expressed in degrees Celsius or Fahrenheit).
  • Δt_i is the duration for which temperature T_i was maintained (expressed in hours, minutes, or seconds).
  • n is the number of measurements taken during the studied period.

However, for a more precise calculation of MKT, especially when considering the effect of each temperature variation on the product’s stability, a formula that incorporates the concept of thermal activation factor (often based on Arrhenius-type equations) is commonly used. The more advanced formula, integrating this factor, is:

where:

  • T_i is the temperature measured at a given moment,
  • Δt_i is the duration of exposure to that temperature,
  • τ is a time constant, representing the average exposure duration of the product to a given temperature,
  • a is an empirical parameter that represents the product’s sensitivity to temperature variations (often estimated through laboratory studies on product stability).

This more complex model allows for weighting the impact of periods during which the product is exposed to extreme temperatures (e.g., high or low temperatures), which are typically more harmful than periods at moderate temperatures.

Practical Applications of MKT

Mean Kinetic Temperature is widely used in industries where thermal management is critical. In the pharmaceutical field, for instance, medications or vaccines requiring strict cold chain management can be monitored using MKT. If the temperature exceeds specified limits for a significant duration, MKT can indicate a risk of product degradation.

In the food industry, MKT is used to ensure that perishable goods such as meat or dairy products are stored and transported at safe temperatures, preventing bacterial growth and other temperature-related alterations.

Conclusion

Mean Kinetic Temperature (MKT) is a crucial concept for assessing the thermal impact on temperature-sensitive products. By accounting for the cumulative effect of thermal fluctuations, MKT provides a reliable method for ensuring product quality and effectiveness while meeting regulatory standards. When calculated properly, MKT offers valuable data for improving supply chain management and logistics of temperature-sensitive products, whether they are medications, food items, or other goods sensitive to temperature.

Détecter les excursions de température pendant le transport

Full temperature traceability of pharmaceuticals in 7 seconds

How to combine modern technology and many years of experience in supply chains of pharmaceuticals around the world?

The cooperation between the French-Polish company Blulog and Thermolabo from France shows how to.

The strength, efficacy, and potency of a drug can be profoundly degraded by changes in temperature and drugs should be stored and transported only within temperature conditions under the terms of their Marketing Authorisations (MA) if defined.

Any excursion outside this range may result in having an influence on the main degradation factors of drugs and/or potentially lowering or losing the therapeutic effectiveness of a drug.

Exposed to external conditions, transport is one of the least reliable pharmaceutical processes and in the real life, excursions during transportation are not rare events.

An effective temperature monitoring is therefore an essential component of Good Distribution Practice (GDP) followed by the people dealing with transport, storage, and distribution of pharmaceuticals before their final dispense to patients.

In this context, Stéphane Mure founded Thermolabo in 2015 to help pharmacists and Qualified Persons (QP) to provide billions of people access to high quality medicines.

Thermolabo’s activity was initially focused on temperature data management and dataloggers supply services. We were constantly obliged to address the same problems generated by traditional dataloggers and decided to look on how to provide our customers a compliant, easy to use, geolocated and low-cost way to monitor their pharma products.

After testing GSM, Bluetooth and IoT technology, it become quickly clear that only NFC Contactless technology can fit with all expectations and we engage a partnership with Blulog to develop a pharma-centric contactless monitoring solution.” says Stéphane Mure, CEO at Thermolabo.

From the beginning, the French company initiative was driven by simplicity.

“Above all, a NFC contactless datalogger is very easy to use. With one movement in less than 2 seconds, thanks to Sensolabo® it is now possible to read, send and instantly store the data and being alerted by email without any technical installation.”

The developed solution now brings enhancement in all fields:

“Sensolabo® strengthens compliance by eliminating data manipulations and reduces goods receiving time and workload…it only takes 5 seconds to start and 2 seconds to process..that give you all your time to monitor serenely”.

The French company bases its services on modern technologies. The key is cooperation with Blulog, a Polish-French company that has found and patented an intuitive solution to support temperature monitoring. The system works on the NFC technology. Credit card size data loggers perform measurements with a setup measurement interval and are equipped with a coin cell battery and the data is encrypted and collected in the application.

Our data loggers measure the temperature with accuracy of +/- 0.2 ° C in the range from 0 to 30 ° C and +/- 0.4 ° C in the remaining range. Detailed data is available at all times using any Android, NFC-equipped phone or special readers. Then users can store data on a secure server, get access automatically generates reports and charts.” says Jérémy Laurens, CEO of Blulog.

The data loggers can be mounted in refrigerators, medical staff rooms, but also in containers or vehicles used for transporting medicines. Such a range of possibilities means that the Thermolabo services based on Blulog technology are used in France or other drug companies throughout Europe, Asia and the Middle East. What’s more, an important advantage of the system is the simplicity and rapidity of use – to start the device, users have just to press the button for a few seconds.

The technology is already used by pharmaceutical companies and drug distributors around the world, major NGO-s and different medical entities, as well as other international companies, including DHL

 

 

pharmacienne qui se pose des questions

Recommendations concerning the transport of health care products under controlled temperatures

Good Manufacturing and Distribution Practices

Within the framework of their public health responsibilities (articles R. 5124-36, R. 5124-48, R. 5121-23 and L. 5124-2 paragraph 2 of the Public Health Code, Good Manufacturing and Distribution Practices, etc.), pharmaceutical establishments must provide a high level of quality in the manufacturing of health care products for dispensing to patients.

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