USP Regulatory Blog Series, Part 3
USP <1079.2> Mean Kinetic Temperature More Clearly Defined; Storage and Transportation of Drug Products
In the final blog of this series, we will clearly define sub-chapter USP <1079.2> Mean Kinetic Temperature. The United States Pharmacopeia (USP) is scheduled to make changes to key chapters that may affect life sciences companies. It is important that all life sciences companies become aware of the changes and plan how the changes will affect their storage and distribution.
USP <1079.2> Mean Kinetic Temperature Defined
The United States Pharmacopeia (USP) is scheduled to release changes in August 2020, to sub-chapter USP <1079.2>, which will be made official in December 2020. USP <1079> outlines good storage and distribution practices for temperature-sensitive drugs across all stages of the supply chain. USP <1079.2> is a new sub-chapter providing more guidance around Mean Kinetic Temperature/em> (MKT). Mean Kinetic Temperature expresses the cumulative thermal variability experienced by a product during storage and distribution. Excessive thermal variability will result in an unacceptable MKT value.
Mean Kinetic Temperature Challenges
Challenges with the use of Mean Kinetic Temperature over the years and within the pharmaceutical industry have centered around three main topics:
- How much temperature data is too much when calculating MKT?
- Can MKT only be used for storage or can it also be used within transportation?
- Can MKT only be used for Controlled Room Temperature (CRT) products or can it also be used for refrigerated products?
This new sub-chapter USP <1079.2> defines limiting how much data to use when calculating MKT, along with an explanation of its use for transportation and refrigerated shipments.
Many organizations still use 52 weeks of temperature data to calculate MKT. For the Storage of CRT products, this new chapter defines that a maximum of 30 days of temperature data may be used for the calculation of MKT. Similarly, for the new refrigerated temperature category called “Controlled Cold Temperature,” only 24 hours of data during transportation may be used to calculate MKT. For more information about the new definition Controlled Cold, see Why are USP <659> Packaging and Storage Requirements Important?
The Benefit of USP <1079.2>
The goal of this new sub-chapter is to limit the amount of data used and the time period in the MKT calculation -- calculating over a longer time period increases the amount of data used, which can potentially dilute results and create acceptable MKT values, when the product actually may have been temperature abused. By limiting the timeframe of data used to calculate MKT (maximum of 30 days), it will result in MKT values that better depict the actual temperature a product may experience during storage or transportation.
Read more about USP <1079.2> and the revised USP <1079.2>. This concludes the USP <659> and <1079> series. Return often to learn about other regulatory changes that Sensitech experts are monitoring to help customers become compliant while improving quality and cost to their supply chain.