4 Common Questions on MKT Answered: Trending, Interpreting Reports, & Default Activation Energy

4 Common Questions on MKT Answered
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Paul Daniel
Sr. Regulatory Compliance Expert
Feb 25th 2017
Industrial Measurements
Life Science
Science & Sensing Technologies

In this week's blog, Paul Daniel answers a few questions that we often receive on using mean kinetic temperature. But first - make sure you don't miss this week's webinar on Data Integrity. We have over 650 people registered, but still room for you!

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Dear Paul,

I have a couple questions regarding the mean kinetic temperature value for a recent temperature study of three of our warehouses here at our nutraceutical distribution center. We generated a "historical data report" using the Vaisala mapping software, however, we still have some uncertainties on what numbers we need and how to correctly read the report.

First, in the software we noticed under "Options > Historical Data Report Statistics" that we can change the values of the statistics time interval to our sample time of 14 days and this changes the sample time in the actual report. We also notice that we can change the MKT activation energy, which changes the MKT value in the report. But, here our interpretation is fuzzy. What exactly is the activation energy value and what should it be set at? Second, in the report, there are two columns labeled as Groups. What are these columns indicating?

Third, there is an MKT value on line 54 and a Min MKT value at line 68. Is there a Max MKT value?

Fourth, which MKT value is the correct one to use in our trending reports?

Finally, as stated, we are performing temperature studies every quarter of 2016 on three different warehouses. If we want to trend the MKT data over the course of year, is it best to take the average of all MKT scores to find a global average or is there a better calculation for trending the MKT score?

We appreciate your time and attention to our queries!

B

 

Dear B,

Thank you for contacting us! I always enjoy answering questions that are specific to our solutions ☺

Also, you are not alone in your questions – we are often asked about MKT. This is why we created a webinar on the topic. If you haven't already, please check it out:

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Now to answer your questions:

  1. By default, the MKT activation energy should be set at 83.144 kJ/mo. This value was historically selected as the customary value for GMP reporting because it made the math a lot easier (for manual calculations), and it is a representative of reaction rates for zero order thermal degradation of most biological molecules at ambient temperatures. So, unless you have done a study to determine a more representative value for a specific product, stick with this default value. See this application note for more information about the calculation of MKT.

    2) The "Groups" columns simply indicate that these statistics are the statistics for a selected group, usually all the temperature channels included in the report.

    3) The MKT value on Line 54 is for that particular temperature channel only – in this case, Logger 1 / Channel 1. The value on Line 68 is the lowest MKT score for the group included in the group statistics. However, since your group consists of only one logger, the value is the same. When reporting on single loggers, it is recommended to not include group statistics in your report.


    The max MKT value is not missing. There is no max MKT value. It is rather the presence of the Min MKT value is a historical error. We should not have included it in the group statistics in the first place. There are two reasons for it:


a) Its inclusion was based on us simply following the reporting characteristics of another calculated value – Lethality (FO) – in which the minimum is important.

b) MKT is generally not a reported value for a group but is reserved for investigation of excursions, as you can't have a problem with MKT unless you already have a problem with your temperature values.

  1. To answer your question about the correct value to use in your reports, I would need to know more about your application to make recommendations on how to trend your MKT values. Remember that the MKT itself is a logarithmic weighted average already for each space over time, so there is little use in averaging MKT across different spaces.

    But, if you do report MKT for Trending, it should be for each individual sensor using a time frame for that calculated value that matches the average time an item is stored in your warehouse (such as 14 days or 30 days). You could then present the MAX MKT values for a given location over the course of the year, but this measurement isn't intended to be a performance indicator.

    Recall that MKT is an investigative tool for evaluating high-side temperature excursions in well-controlled room temperature environments. I would caution against using it for anything else, as it can hide actual operational problems. I would instead focus on maximum temperatures and the number + duration of high-side excursions for each warehouse. Then I would look for the highest excursions and longest excursions, and provide an MKT value from the worst location to inform the audience about the averaged impact of the excursion.

I hope this was helpful! Please contact us again if you need further assistance…

Best Regards, Paul Daniel

 

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Author

Paul Daniel

Senior Regulatory Compliance Expert

Paul Daniel is the Senior Regulatory Compliance Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems.

At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications.

Paul also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.