Current practices in endotoxin and pyrogen testing in biotechnology. The Quality Assurance/Quality Control Task Group. Parenteral Drug Association.
This article presents the results of a nationwide survey of the biotechnology industry regarding endotoxin and pyrogen testing and control. It identifies procedures and methods being used by biotechnology companies, and firms working with biotechnology products, in the testing for and detection of endotoxin and other pyrogenic substances. The review attempts to identify areas of commonality and standardization within the industry and includes topics for discussion at the end of the survey results.
D001709:Biotechnology / Q000592:standards*; D004340:Drug Contamination; D004345:Drug Industry / Q000592:standards*; D004731:Endotoxins / Q000032:analysis*; D008033:Limulus Test; D011749:Pyrogens / Q000032:analysis*; D011785:Quality Assurance, Health Care; D011786:Quality Control; D011795:Surveys and Questionnaires; D014481:United States
D004731:Endotoxins; D011749:Pyrogens