RT Journal Article
SR Electronic
T1 Dry Heat Inactivation of Endotoxin on the Surface of Glass
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 4
OP 12
VO 44
IS 1
A1 Ludwig, John D.
A1 Avis, Kenneth E.
YR 1990
UL http://journal.pda.org/content/44/1/4.abstract
AB The thermal inactivation of three endotoxin preparations on the inner surface of glass capillary tubes was studied. The samples were exposed to precisely controlled dry heat conditions at study temperatures ranging from 170° to 350°C, and were assayed using the gel-clot method of the Limulus Amebocyte Lysate test. Plots of the log of the amount ofpyrogenic material remaining versus heating time revealed apparently biphasic destruction curves. The initial slopes were linear to a minimum 3-log unit reduction, and were followed by slower destruction rates for the terminal slopes. D values were calculated from the initial slopes of the destruction data, and Z values were estimated from the D values. The D and Z values were found to vary with the initial charged amounts of endotoxin. A second-order equation was found to be an inappropriate model for the inactivation process at temperatures between 170° and 250°C, but was found to be suitable for temperatures between 250° and 325°C. The data were successfully fit to a biexponential equation for all the temperatures studied. The overall inactivation rate of the endotoxin material formulated with fillers was apparently faster than that for the pure endotoxin preparations.