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Data Loggers For Pharmaceutical Applications


Data Loggers For Pharmaceutical Applications

Data loggers are commonly used for monitoring temperature in pharmaceutical applications. The SL50 series are small enough to fit inside small bottles. The SL7000 series are versatile enough to be used in a wide variety of applications like fridge or freezer monitoring. The wireless spYdaq system provides near real time monitoring with the added bonus of SMS or email alarms. SpYdaq is easily installed into existing facilities where traditional, hard wired installations, would prove too costly or cause too much disruption. With the exception of the spYdaq system, most of the following data loggers use our feature packed TempIT software that can be used to automatically calculate MKT. 

SL52T-A Temperature data logger with UKAS traceable calibration certificate
SL52USB-A USB temperature data logger with UKAS traceable calibration certificate
SL54TH-A Temperature and relative humidity data logger with UKAS traceable calibration certificate
SL54USB-A USB temperature and relative humidity data logger with UKAS traceable calibration certificate
SL7000 Series Versatile data logger with four channels
SpYdaq Wireless monitoring solution with SMS / email alarms
TempMate Single use temperature data loggers with PDF file output

What is Mean Kinetic Temperature and why is it important?

Most Signatrol temperature data loggers, running TempIT-Pro software, can be configured to compute and record mean kinetic temperature (MKT).

It is widely recognised that calculating MKT gives a far more representative picture of the effect of temperature change on sensitive materials, such as pharmaceuticals and food products, during storage and distribution. The shelf life of sensitive materials is directly related to MKT.

The United States Pharmacopoeia (USP) defines MKT as a 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. In non-technical terms, MKT converts a variable temperature into an equivalent steady temperature, which is used to determine the effect of the excursion on product quality. For example, USP recommendations for “controlled room temperature” state that the temperature should be maintained between 15°C and 30°C, with a MKT of less than 25°C. The calculation gives increased weighting to higher temperature excursions than normal arithmetic methods, recognising the accelerated rate of thermal degradation of materials at higher temperatures.

Measuring MKT with Signatrol data loggers

The Signatrol SL151T temperature loggers are specifically designed to travel with goods and provide a detailed date and time temperature profile that can be used to highlight any problems. The data loggers are housed in a fully weld-sealed, crevice-free, food-grade polystyrene bags that are only 10mm thick. These data loggers are the only ones approved by the Royal Institute of Public Health.

The Signatrol SL151T data logger series uses a patented induction technique for set-up and data download. As a result, there are no plugs, sockets or entries of any kind, thereby avoiding potential “bug traps” and ensuring full sealing. Powered by an internal battery, these data loggers can log at intervals from 30 seconds to 100 hours and have a measurement range from -30°C to +60°C. They have a delayed start feature that allows them to function according to a specific travel schedule and have an internal capacity of 24,576 readings, which means they can keep recording for more than four years.

As well as the Signatrol SL151T series, the Signatrol SL52T and SL7000 data loggers can also be used to measure MKT.

Calculating MKT with Signatrol TempIT-Pro

If you use Signatrol TempIT-Pro software, you can quickly and assuredly calculate MKT. The software has an in-built calculator that carries out this task. TempIT software is free to download. MKT can be also calculated using the Arrhenius equation. 

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Using Signatrol TempIT-Pro software, all you have to do is enter the activation energy during set up (this can vary from 42-125 kJ/mol). The activation energy can be determined by differential scanning calorimetry.

MKT = (-DH/R)/Ln{(SUM(exp(-DH/R*Tn))))/n}

DH is the activation energy, R is the universal Gas Constant (.0083144 kJ/molK), T is the temperature in Deg K, and n is the total number of equal time periods over which data are collected. Ln is the natural log, exp is the natural log base and SUM is the total over n periods.

For more information about Signatrol data loggers and data logging systems, contact us on +44 (0) 1684 299 399 or by using our enquiry form.