The investigation of the efficacy of the cooling element in the mode of "cold chain"

Abstract

The pharmaceutical market of remedies is actively developing in the direction of biotechnologies, due to the increase of using the targeted therapy in contrast to the conventional therapy, the increase of demand for monoclonal antibodies, the prescription of orphan medicines, vaccines and biosimilars [5]. Especial attention is foccused by medical immunobiological preparations (MIBPs) which are used for the immunoprophylaxis and the immunotherapy, and require the special storage conditions, videlicet the organization of storage, transportation and the usage with the help of the "cold chain". Therefore, pharmaceutical enterprises are taking additional measures to ensure the quality of their products from the beginning of the manufacture to the distribution of their products. A significant part of the MIBPs requires the storage conditions of a fairly narrow temperature interval from +2 ºС to +8 ºС, and the temperature of +5 ºС is optimal. Certain vaccines can be stored and transported at a temperature from -80 ° C to +2 ° C [4]. In Ukraine the requirements of the creation of a cold chain and abidance by the terms of storage and transportation of MIBP are regulated by certain regulatory documents [1, 2]. But definite complexities, such as the absence of common standard testing methodologies for insulated containers, refrigeration rooms, refrigerating equipment, carrier vehicles and temperature control devices, as also the lack of standard requirements for a temperature control system in the cold chain, require MIBP manufacturers to apply a scientific approach during the development of the "cold chain" in order to ensure the quality of their remedies [3]. The cooling elements, which are packed together with MIBP, take on an indispensable the role in providing and maintaining the established temperature regimes. Therefore, the efficacy of the cooling element has a direct critical influence on the preservation of the quality of medical remedies.