The Importance of MKT in the Pharmaceutical Sector
Monitoring production environments, storage facilities and distribution processes is becoming increasingly important, especially in the pharmaceutical and agri-foods sector.
In recent years, regulatory and government bodies worldwide have shown increased scrutiny in these areas and have pushed for the adoption of drug storage standards.
The result has been the adoption of the use of Mean Kinetic Temperature (MKT) in many jurisdictions worldwide.
MKT is a simplified way of expressing the overall effect of temperature fluctuations during storage or transit of perishable goods such as medicines or food items.
MKT can help distributors and manufacturers determine if improper storage and handling of goods occurred and if it has compromised their product.
So how is MKT different than simple numerical averages or arithmetic means? Determining MKT puts a greater weighting on higher temperatures in a temperature series of data. This is because in the pharma and foods sector, there is an accelerated rate of thermal degradation for medicines and other perishable goods. For example, during transportation, goods can be rejected if they deviate from the absolute maximum and minimum thresholds if the calculated MKT is outside the correct conservation thresholds.
Support for MKT is becoming the standard and is supported in a number of regulations worldwide including the United States FDA`s Code of Federal Regulations, Part 203, and the EU`s Guidance on Good Distribution Practices.
Data Loggers are ideal instruments for monitoring production, storage and distribution processes. The Sauermann Group has data loggers that immediately determine the MKT. Any data downloaded from a Sauermann KH 120 datalogger allows the user to access MKT and the vital information needed to comply with regulations and/or make cost effective decisions. In taking these readings, the datalogger indicates the values unit, as well as the minimum, maximum and MKT readings.