![]() Taylor of the Medicine Controls Agency 2 presented a different application for MKT. The article clearly states that for those products whose loss rate constant is related to temperature by the Arrhenius relationship, a single virtual temperature can be determined at which the loss rate is equivalent to that of this changing pattern of temperature. Explained differently, MKT can be determined by calculating a “virtual temperature” that would consider expected temperature variability in a given geography. The original purpose of Hayes’ article in 1971 was to address climate-based temperature variations in uncontrolled pharmaceutical storage to relate to a single temperature that could be substituted for product expiry testing. ![]() Hayes’ frequently cited article, 1 I am proposing moving away from the concept of MKT as the tool to evaluate temperature excursions in transport and storage of drug products. We have come a long way in condition monitoring and control in pharmaceutical storage and transport. By Tobias Kuners of Koenders, managing consultant, Tob Management
0 Comments
Leave a Reply. |