Keeping it On the MKT
For the pharmaceutical industry, like the food industry, it could be said that scrutiny over quality is that much greater – and understandably so. The mean kinetic temperature (MKT) requirement places a significant responsibility on all managers of pharmaceutical storage facilities. It is generally accepted as the yardstick by which quality storage is measured, and forms an integral part of the auditing procedures by the Medicines and Healthcare Regulatory Authority (MHRA).
The MKT is defined by the United States Pharmacopoeia (USP) 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
It is a calculated, fixed temperature parameter, which simulates the effect of temperature variations over a period of time. In particular, it takes into account the likelihood of accelerated product degradation due to high storage temperatures. It is not a simple averaging calculation because it gives greater weighting to higher temperatures in determining the average from a datum. Whilst high ambient temperatures haven’t always been a feature of British summers, recent experience has highlighted the need to plan for preventive action. So what means are available to help control storage conditions to within the MKT? There are three approaches that can be considered: air conditioning; ventilation; and evaporative cooling.