Shelf life prediction of diagnostic fluorescent tularemia dry immunoglobulins

Abstract

We described the results of studying the stability of the main indicators of medicalnroduct quality for in vitro diagnostics - diagnostic fluorescent tularemia dry immunoglobulins RIF-Tul-StavNIPCHI, developed on the basis of Stavropol Anti-Plague Institute of Rospotrebnadzor to justify the shelf life and recommended storage conditions when used on a real scale time and accelerated research methods. At the same time, one of the main criteria for the study of stability is its study during sample storage not only in the primary packaging of an industrial output, but also after the first opening of the package, during the use period of the reconstituted preparation. On the basis of data obtained in both long-term and accelerated trials, a shelf life of three years is recommended. It was experimentally proved that during this period of time, the quality indicators of the drug remain at a level one that complies with the requirements of technical and operational documentation. In the course of application the recovered product demonstrates stability of its biological and physical-and-chemical properties within 5 days at a storage temperature of 2 to 8°С.