FIELD: biotechnology.
SUBSTANCE: method for tracking the concentration of at least one contaminant type in fluid flow is proposed, as well as the use of the specified method in a continuous process to obtain a biopharmaceutical, biological, high-molecular product. The method includes providing technological blocks, ensuring fluid flow through the technological blocks, sampling from fluid flow in a given valid way, determining the concentration of a contaminant in the sample, providing a filter separating technological blocks with pore sizes between 0.05 mcm and 2 mcm, where sampling from fluid flow is carried out by sampling from fluid flow immediately before its passage through the specified filter. The method is carried out under conditions of continuity, isolation and a reduced number of pathogens, wherein the contaminant type is a microbial contaminant and/or a toxic contaminant.
EFFECT: inventions provide for obtaining the sample representing an average concentration of the contaminant or a higher concentration than the average concentration of the contaminant in continuous fluid flow.
14 cl, 3 dwg, 2 ex
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Authors
Dates
2021-09-13—Published
2017-11-03—Filed