Endotoxin removal using 6,000 molecular weight cut-off polyacrylonitrile (PAN) and polysulfone (PS) hollow fiber...

The removal of pyrogenic and microbial contaminants from high purity water and parental solutions during production is a concern to pharmaceutical manufacturers. In a previous study, 6000 molecular weight cut-off (MWCO) polyacrylonitrile (PAN) and polysulfone (PS) ultrafilters were shown to remove poliovirus (Titer reduction [Tr], > 6 logs) and phages T1 and PP7 (Tr, 7 logs) from ultrapure water, 0.85% saline with 1% trypicase soy broth, and Dulbecco's Eagle minimal essential medium with 10% fetal bovine serum (15). In this study, we evaluated the ability of the 6,000 MWCO PAN and PS ultrafilters to remove purified endotoxin (Escherichia coli lipopolysaccharide) which was added to commercial Water for Irrigation. An endotoxin concentration reduction of > 6 logs was achieved with both PAN and PS ultrafilters (detection sensitivity, 0.0031 EU/ml) when a minimum of 3.92 x 10(3) EU/ml of endotoxin was added to Water for Irrigation. These results indicate that the 6,000 MWCO PAN and PS ultrafilters are very effective in removing endotoxin from fluids such as Water for Irrigation.