RT Journal Article
SR Electronic
T1 Evaluation of Endotoxin Retention by Adsorptive-Based Filtration Media
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 75
OP 87
VO 61
IS 2
A1 O'Brien, Thomas P.
A1 Conway, Robert
A1 Chen, Hsiao-Lin
A1 Buckland, Kim
YR 2007
UL http://journal.pda.org/content/61/2/75.abstract
AB Control of endotoxin contamination is an important issue in pharmaceutical and bioprocess manufacturing. Endotoxins can contaminate process intermediates used in pharmaceutical formulations, aqueous- and non-aqueous-based CIP fluids used in equipment and vial cleaning, and process fluids such as buffers used for chromatographic elution, diafiltration, and suspension of therapeutic protein-based drugs. A study was undertaken to evaluate the effectiveness of adsorptive-based depth and membrane filtration media in removing suspended endotoxin. The following variables were examined in order to determine their effects on endotoxin reduction: absorptive media type, residence time (flux), challenge solution pH, and interferences in endotoxin reduction as the result of challenge solution composition—water for injection, process buffer, and the presence of protein. The endotoxin removal capacities of the various media studied were also determined. The results of the study demonstrated differences in the effect on endotoxin removal of the variables evaluated. In addition, the results provide a strategy for conducting studies to select and validate an appropriate adsorptive filter media for control of endotoxin contamination.