1. INTRODUCTION
The extent of physicochemical degradation of drug products depends on factors such as product stability, how a product is stored and shipped, and how it is packaged. Temperature at which a product is stored or shipped is likely to vary during the life of the product, which can impact its degradation rate and stability, thereby leading to the product failing to maintain its critical quality attributes.
Mean kinetic temperature (MKT) is a way to summarize the time history of a product’s temperature exposure with a single “effective” or “virtual” temperature. It is defined as the 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. MKT integrates the time–temperature history by making assumptions about the kinetics of a product’s chemical degradation. Therefore, MKT takes into account the fact that long temperature excursions at slightly elevated temperatures can be just as, or more, impactful than short temperature excursions at elevated temperatures.
2. SCOPE
This chapter applies to every link in the supply chain from the manufacturer through any entity that transports or stores a finished drug product, with the sole exception of the patient. Examples:
Manufacturers of drug products, radiopharmaceuticals, biological products, and biotechnological products
Repackaging operations in which the product may be owned by a company other than the primary manufacturer
Healthcare providers and institutions such as hospitals; outpatient, ambulatory, and urgent care centers; home health providers; vaccine clinics; emergency departments; and medical, dental, and veterinary offices
Pharmacies including but not limited to retail, infusion/compounding, specialty, mail order, hospital, nursing home, and hospice
Importers and exporters
Wholesale distributors
Third-party logistics providers, brokers, freight forwarders, consolidators, and other organizations involved in storage; road, rail, sea, and/or air transport services; or mail distributors that offer expedited or controlled-temperature shipping services
Manufacturers of active pharmaceutical ingredients, excipients, medical devices (with the exception of drug combination devices), and dietary supplements are not within the scope of this chapter. However, the principles and mitigation strategies presented in this chapter may be useful for materials other than finished drug products.
3. MEAN KINETIC TEMPERATURE
MKT is the 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. MKT may be considered as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variation.1 Seevers et al. demonstrated that the choice of activation energy doesn’t change the MKT significantly. It is not a simple arithmetic mean. The use of MKT is considered an acceptable practice for storage and can be considered for excursions during transit.
The temperatures used for calculating MKT can be conveniently collected using electronic devices that measure temperatures at frequent intervals (e.g., every 15 min). MKT can be calculated directly or the data can be downloaded to a computer for processing. Software to compute the MKT is available commercially.
The arithmetic mean of the weekly high and low temperatures is then used in the calculation of MKT. MKT is calculated by the following equation (derived from the Arrhenius equation):
Source from USP and Please refer to USP for details:
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