Mean Kinetic Temperature (MKT): A False Sense Of SecuritySource: Infitrak, Inc.
Accurate measurement and documentation has become an increasingly important issue for biopharmaceutical industries as regulatory agencies put increasing pressure on manufacturers to ensure the safety of their customers. This scrutiny has come with the benefit of increased product shelf life and better, more efficient distribution practices (cGMPs). Tied to this efficiency are the use of remote monitoring solutions and data loggers that are able to not only measure and document environmental excursions (temperature, humidity, etc) but alert quality assurance and other personnel of an impending issue.
While the FDA, Health Canada, International Conference on Harmonization (ICH) and European Union (EU) all agree that stable, measurable shipping and storage conditions need to be maintained, the amount of detail behind these conditions varies from region to region. Most, however, require well documented verification of these storage environments, and documenting of any corrective actions taken if temperatures exceed specified storage conditions.