Abstract

ZAMANILLO SAINZ, A. et al. Conditions of drugs transportation in international missions of the Armed Forces: Design of a specific stability study of operations. Sanid. Mil. [online]. 2012, vol.68, n.3, pp.147-156. ISSN 1887-8571.  https://dx.doi.org/10.4321/S1887-85712012000300004.

Introduction: The supply of medical materiel and pharmaceuticals is a critical part of medical support in our military operations. The transport of medical materiel and drugs is provided by Air. The drug regulation requires performed storage and transportation conditions so that its quality are maintained during the whole period of drug validity, so a quality transportation should not generate risks to drugs derived from high temperature, cold, humidity or other negative factors, such as microorganisms or pests. We characterize, therefore, the environmental conditions associated to the transport with the measurement of the temperature and relative humidity. Objective: Qualification of drug transport. Design of a specific stability study to Operations (SSO). Materials and Methods: Monitoring is performed for the drugs transport ROLE 2 E (Herat) during an annual cycle. Data logger are used: LOG 32 with measurement range -40 to +70 ^oC and 0 to 100% RH and program for calculating the parameters of qualified shipments for the qualification and evaluation of transport. Different laboratory equipments and their corresponding methods for stability testing. SPSS version 15 for the treatment of results. Results: The maximum and minimum recorded temperatures in the 18 transports monitored, during 13 months, show values that not exceed the limits in the proposed test stability. Mean relative humidity was maintained on a regular basis during the period monitored, at values below 50%. The analytical results of the drugs tested against stability, based on the of fluctuations temperature application in different cycles, give values that are within the specifications of the finished product, without significant differences between control products and the products subjected to thermal variations, showing that the oscillations of 2 ^oC and 50 ^oC set for the trial, during a period of 7 days, do not affect the drugs characteristics selected in this study. Conclusions: Have been evaluated environmental characteristics of transportation during an annual cycle, showing there are not remarkable seasonal differences between the various shipments. From the environmental standpoint, drugs transportation to Role 2 (Herat) is qualified. All medicines produced by the Military Pharmacy Center of Defense, choosen in this study and which have been subjected on the new stability test, remain within specification, by what alteration is not observed in the quality of the same ones. In order to control the drugs transport to the International Mission, temperature fluctuations between 2 ^oC and 50 ^oC during at least 7 days would be considered safe conditions.

Keywords : Drug Transport; Stability; International Mission.

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