RT Journal Article
SR Electronic
T1 Extraction of Bacterial Endotoxin from Medical Devices
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 287
OP 291
VO 40
IS 6
A1 Christine W. Twohy
A1 Anthony P. Duran
A1 James T. Peeler
YR 1986
UL http://journal.pda.org/content/40/6/287.abstract
AB A 1984 collaborative study was undertaken to determine the efficacy of an extraction procedure for bacterial endotoxin. Twelve laboratories from government and industry participated in the study. The study consisted of three samples of 8 medical devices contaminated with duplicate amounts at various endotoxin concentrations derived from three different sources: a raw Pseudomonas cepacia (ATCC #25416) endotoxin, the USP reference standard endotoxin EC-5, and Difco E. coli endotoxin 055.B5 (lot 504089). The extraction procedure was performed on the devices and the eluates were tested for endotoxin content using the Limulus Amebocyte Lysate gel tube test. The percent recovery of endotoxin from the devices ranged from 42 to 120%.