Abstract
One of the ways to neutralize immunobiological production waste is their treatment in sterilizers with saturated water vapor under pressure. Currently, medical and pharmaceutical industries and laboratories use sterilizers with sterilization and disinfection programs preset by manufacturers. Decontamination modes are defined in Federal sanitary rules, norms and hygienic standards, SanPiN 3.3686-21, while the parameters of preliminary phases of the cycle must be tested experimentally and validated for specific conditions. Within the frames of this study, we have tested the modes of disinfection of an automatic steam sterilizer by the example of waste products from the production of cholera vaccine and anti-rabies immunoglobulin manufactured by the FSSI Russian Anti-Plague Institute «Microbe» of the Rospotrebnadzor. The wastes are used nutrient media, carcasses of laboratory animals (rabbits) and consumables. The chamber was loaded with «clean» objects in quantity and configuration, repeating the loading of material with pathogenic biological agents (PBA). The mode of inactivation inside the chamber and the objects was controlled by physical, chemical and biological methods. Based on the results of the experiments, corrective actions were taken to change the program and design of containers for autoclaving. It was concluded that the default disinfection programs set by manufacturers do not fully take into account specific conditions and need to be adjusted with further validation. It is necessary to develop standard operating procedures for personnel involved in the decontamination of pathogenic materials, in which should be stated the order of placement of objects and the means of control in the containers with PBA and the sterilizer chamber. Keywords: steam sterilizers, pathogenic biological agents, disinfection with saturated water vapor, phases of the steam disinfection cycle, validation.
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