Automation of microtiter plate-chromogenic substrate LAL endotoxin assay method by use of a modified Cetus Pro/Pette Express system
Martin, P.A.; Gaunnac, G.L.; Tsuji, K.
Journal of Parenteral Science and Technology a Publication of the Parenteral Drug Association 40(2): 61-66
1986
ISSN/ISBN: 0279-7976 PMID: 3723252 Document Number: 283099
An automated microtiter plate-chromogenic substrate LAL system for the assay of bacterial endotoxin has been developed using a Cetus Pro/Pette EXPRESS system, modified with the addition of a solid-state incubator block. The automated system assays 96 samples in approximately 22 min. Sensitivity of the automated system is approximately 0.01 EU/ml with a linear assay range from 0.03 to 0.14 EU/ml and the relative standard deviation (RSD) of approximately 6%. The automated microtiter plate-chromogenic substrate LAL system has been validated for testing a variety of pharmaceutical injectable products and materials. The automated system has been shown to represent significant improvements in speed, accuracy, and precision of the LAL assay method for endotoxin.