Automatic Mean Kinetic Temperature Calculation and Reporting

Prodigy functionality provided for pharmaceuticals company

Pharmaceutical industry regulations require that storage and transport temperatures are properly monitored and controlled. In addition, everything must be well documented, including corrective actions when certain temperature conditions are exceeded.

Out of specification temperature and humidity levels can cause serious damage to produced materials and even the final product. This point is especially important in the pharmaceutical industry. Regulatory bodies dictate that pharmaceutical and food products must be stored under controlled environmental conditions.

Temperature and humidity are the most important factors for these products to retain their shape, strength, quality ‘and purity.

The climatic conditions of warehouses are subject to regulatory compliance : monitoring and validation are required , which allow for greater safety during the storage phase of products. When it comes to monitoring climatic conditions when storing heat-sensitive products in warehouses, it is important to ensure that the measuring instruments used always provide reliable and repeatable results. The temperature and humidity values must be automatically detected and documented.

To assess whether storage has affected the quality of the product and its shelf-life Mean kinetic temperature (MKT) is used. MKT is defined as "A single derived temperature which, if maintained for a defined time, causes the same thermal effect to substance or biological product that would occur with a sequence of lower or higher temperatures for a period of time equivalent". It is higher than the arithmetic mean and is calculated using the Arrhenius equation.

Technically speaking, MKT is an expression of the cumulative thermal stress experienced by a product at varying temperatures during storage and distribution. In other words, MKT is @ single calculated temperature which is analogous to the effect of temperature changes over a period of time.

The system is designed to continuously monitor storage area temperature from sensors; alarm when temperature level from any sensor goes out of range (or if the sensor fails). It will also calculate MKT automatically in real time providing accurate data to determine likely product degradation.

MKT is not a simple weighted average. Calculating MKT gives the highest temperatures of greater weight when averaging than a simple numerical mean or arithmetic mean would. This weighting is determined by a geometric transformation of the natural logarithm of the absolute tenperature.

A Prodigy system provides MKT calculation and reporting for a pharmaceuticals manufacturer to allow automatic calculation of ‘the Mean Kinetic Temperature.

The system performs the MKT calculation based on the following equation:

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The following values are used in the calculation;

AH = 83.144 KJ per mol - It is possible to set the value of the activation energy, a parameter necessary for calculating the MKT index.

R = 8.3144x10° KJ per degree per mol

The system allows the customer to select groups of signals to perform the MKT calculation on and define a value of AH if required.

Reports are generated once per month (or on demand) for the configured groups of signals.

Reporting indicates any signal alarms over the month and the MKT value.

Reports can be automatically emailed to users configured on the system.

MKT calculation over any time period selected on a single signal is included from the configuration program and provides a text output of the MKT.

The system takes temperature and humidity data from existing sensor probes in the storage areas.

If you have a similar requirement please contact us for further information.