Pyrogen Removal by Ultrafiltration — Applications in the Manufacture of Drugs and U.S.P. Purified Water

Abstract

In almost all practical cases, the nature of pyrogenic material is the lipopolysaccharide outer coat of gram negative organisms. The pyrogen retention efficiency of an ultrafiltration membrane is strongly influenced by the size and state of aggregation of such lipopolysaccharide molecules. Data is presented, showing the retention characteristics of a number of nominal molecular weight retention membranes when challenged with solutions of LPS in different states of aggregation. Practical examples of pyrogen removal from parenteral drugs, including dextrose solutions, antibiotic preparations and U.S.P. purified water, are presented, with special emphasis on system design approaches and overall process economics.