SHELF LIFE PREDICTION OF DIAGNOSTIC FLUORESCENT TULAREMIA DRY IMMUNOGLOBULINS

We described the results of studying the stability of the main indicators of medical product quality for invitro 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 andrecommended storage conditions when used on a real scale time and accelerated research methods. At thesame time, one of the main criteria for the study of stability is its study during sample storage not onlyin the primary packaging of an industrial output, but also after the first opening of the package, duringthe use period of the reconstituted preparation. On the basis of data obtained in both long-term andaccelerated trials, a shelf life of three years is recommended. It was experimentally proved that duringthis period of time, the quality indicators of the drug remain at a level one that complies with therequirements of technical and operational documentation. In the course of application the recoveredproduct demonstrates stability of its biological and physical-and-chemical properties within 5 days at astorage temperature of 2 to 8°С.