If your mapping data is within acceptable QA limits for your product and your MKT is less than 25☌ your area is in the clear! If done correctly, all of the numbers used to determine MKT yields one temperature. or can be imported into your own validated MKT Excel spreadsheet. The data generated can then be imported into MKT programs, such as iStability® MKT, from my good friends at ScienTek Software, Inc.
Vacker Group supplies all types of data loggers in United Arab Emirates, Qatar, Kuwait, Kingdom of Saudi Arabia (Riyadh, Dammam & Jeddah), Bahrain, Jordan, Iraq and Oman. Please read complete article on calculation of MKT. We also supply temperature data loggers with MKT valuein which you can see the MKT value in the report. We typically run mappings for 72 consecutive hours at 10 to 15 minute intervals. This is the method of calculation of Mean Kinetic Temperature (MKT) from the readings of data loggers using Excel sheet. For larger areas, such as warehouses, IIS will use dataloggers. For smaller areas, IIS will use a GE-Kaye Validator 2000. This is usually performed by mapping the area.
MKT CALCULATION SPREADSHEET HOW TO
How to apply MKT? Generating MKT may be easier than most people think. Mean Kinetic Temeprature (MKT) is a mathematical formula (the Arrhenius Equation) used to determine the overall effect of temperature on drug products. What does this all mean? In lamen's terms it means keeping the area where drug product is stored controlled so that the temperatures do not adversely effect the drug product. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variations.
MKT CALCULATION SPREADSHEET DOWNLOAD
Articles may be labeled for storage at “controlled room temperature” or at “up to 25°”, or other wording based on the same mean kinetic temperature. Spreadsheet calculation You will download from Moodle an Excel spreadsheet that solves the equations found in the Appendix. Spikes above 40° may be permitted if the manufacturer so instructs. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40° are permitted as long as they do not exceed 24 hours.
USP 34-NF29 General Notices: Preservation, Packaging, Storage, And LabelingĬontrolled Room Temperature-A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25° (68° to 77° F) that results in a mean kinetic temperature calculated to be not more than 25° and that allows for excursions between 15° and 30° (59° and 86° F) that are experienced in pharmacies, hospitals, and warehouses.
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