FUJIFILM Wako Chemicals U.S.A. Corporation is pleased to announce the release of Endotoxin Indicators, in the form of ready-to-use challenge vials, for depyrogenation processes of dry heat oven validations. Each vial contains >1,000 Endotoxin Units of lipopolysaccharide made from E. coli O55:B5. This product does not contain any stabilizers or fillers and complies with the requirements of USP <1211> and <1228> for endotoxin challenge vials used as endotoxin indicators.
USP <1211> advises an endotoxin challenge must be included to validate any dry heat process. This is usually performed with an item that is inoculated with endotoxin and then proven, through means of the the dry heat process, to be rendered pyrogen free. The process, completed after the depyrogenation cycle, is to confirm the log reduction of the endotoxin concentration by taking the Endotoxin Indicator after baking and comparing the concentration of endotoxin remaining to the non-processed or unbaked Endotoxin Indicator. The goal, as described in USP <1228>, is to recover a minimum 1,000 Endotoxin Units (EU) and confirm at least a 3-log reduction in endotoxin levels during the depyrogenation cycle. By utilizing these Endotoxin Indicators, with our PYROSTAR™ ES-F series LAL reagent in a gel clot or kinetics assay, one can be certain the reagent and indicators comply with all governing standards.
FUJIFILM Wako Chemicals U.S.A. Corporation offers the Endotoxin Indicators, with potency of >1,000 Endotoxin Units (EU), in a box containing 25 ready to use challenge vials to perform your validation study. This product eliminates the additional steps, materials, and time which would be required when creating in house Endotoxin Indicators from a high concentration LPS. When pairing FUJIFILM Wako Chemicals U.S.A.’s Endotoxin Indicators and our PYROSTAR™ ES-F series LAL reagent you are certain to receive high quality products with accurate results. Thus, you can confidently proceed knowing the depyrogenation processes of your dry heat ovens are performing correctly.