Endotoxins: Pyrogens, LAL Testing and Depyrogenation, 3rd Edition (e-Book) book cover


Pyrogens, LAL Testing and Depyrogenation, 3rd Edition

Edited by Kevin L. Williams

CRC Press

440 pages

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Hardback: 9780849393723
pub: 2007-02-23
eBook (VitalSource) : 9780429121036
pub: 2007-02-23
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This source expertly examines the discovery, biological structure, control, and continued clarification of endotoxin from a parenteral manufacturing perspective, with in-depth discussion of state-of-the-art technologies involving Limulus amebocyte lysate (LAL) such as assay development, automation, depyrogenation.� Completely revised and exp

Table of Contents

Background.� Historical and Emerging Themes in Parenteral Manufacturing Contamination Control.� Endotoxin Relevance and Control Overview.� Fever and the Host Response.� Endotoxin Structure, Function and Activity.� Descent of Limulus.� Microbial Biodiversity and LPS Heterogeneity.� Nonendotoxin Microbial Pyrogens: Lesser Endotoxins, Superantigens and Adventitious Agents.� Parenteral Drug Testing.� Risk Assessment in Parenteral Manufacturing.� Endotoxin as a Standard.� LAL Discovery, Mechanism and Application.� LAL Assay Development, Validation and Regulation.� The Pyrogen Test.� Pyrogenicity Case Studies.� Developing Specifications for API, Excipients and Sterile Pharmacy Compounds.� Depyrogenation Validation, Pyroburden, and Endotoxin Removal.� Automation, PAT and Prospective Tests.� Medical Devices.� LAL Testing of Medical Devices.� Clinical.� Receptors, Mediators, and Mechanisms Involved in Bacterial Sepsis and Septic Shock

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology