5PSQ-145 Abstract withdrawn

<h3>Background and Importance</h3> The mean kinetic temperature (MKT) corresponds to a single calculated temperature at which the total amount of degradation during a given period is equal to the sum of the individual degradations that would occur at various temperatures. <h3>Aim and Objectives</h3> Demonstrate the importance of the integration of mean kinetic temperature tool, to integrate and standardise its use in hospital pharmacy. <h3>Material and Methods</h3> A temperature excursion of three cold rooms 2–8°C) occurred in our pharmacy service for a duration of 12 hours. We conducted a study for the analysis of the thermal stress undergone by the products at variable temperatures for the period from 12 hours before the excursion to 24 hours after, using the MKT. The MKT was establishing based on J. D. Haynes’s formula. <h3>Results</h3> The implemented system provided temperature values readings at 10 minute intervals. However, we selected 18 specific monitoring points. For each point the MKT was calculated and subsequently we determine the average MKT, derived from the individual MKT values of all selected points. The minimum and maximum temperatures recorded for each cold room are as follows: 3.90°C to 13.05°C for the first cold room, 3.85°C to 17.85°C for the second, and 14°C to 17°C for the third one. The MKT average was successively, 6.26°C, 7.29°C and 7.20°C. The MKT results of each cold room were in compliance with a norm of 5±2°C for thermolabile products intended to be stored in cold rooms. Therefore, temperature fluctuations have no impact on the stability of the products and the total excursions equivalent to 12 hours may be tolerated. To manage these temperature excursions in our hospital practice, we rely either on technical drug document obtained from the regulatory authority, or to stability databases, especially since we do not have the resources for conducting analytical testing of the samples. <h3>Conclusion and Relevance</h3> The MKT will be an important tool globally to set excursion limits for storage. This tool may help hospital pharmacists in the decision making process as to whether to keep or discard a product after excursion. However, MKT alone is not enough to assess the impact of temperature excursion, so it’s necessary to make an analytical control. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest