| Abstract |
A SINGLE-STAGE PROCESS FOR THE DEPYROGENATION OF AN INJECTABLE SOLUTION OF CONTRAST AGENT The present invention relates to a single-stage process for the depyrogenation of an injectable solution of contrast agent for diagnostic imaging, said process operating on solution volumes of up to 800-1500 L and comprising the following steps:a) prefiltering the solution by means of a microfiltering unit, b) passing the solution from step a) through an ultrafiltratio unit consisting of one or more filtration modules whicha re capable of operating simultaneously or individually, said modules being equipped with cellulose-based tangential-ultrafiltration membranes having an average cut-off of 10000 Dalton to prevent passage of bacterial endotoxins, whereby a retentate and a permeate complying with the limits set by the pharmacopoeia for the pyrogen content are obtained; c) recycling teh retentate from said ultrafiltration unit directly to teh solution from step a), andd) collecting the permeate in a collector, where it is homogenized under agitation before being made up. |