This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.

This source expertly examines the discovery, control, and application of endotoxin form a parenteral manufacturing perspective, including discussioins of assay development, automation, depyrogenation, and the regulation of endotoxin testing by amebocyte lysate(LAL) methods. Completely revised and expanded, this source contains the knowledge necessary to apply endotoxin technologies in the increasingly complex pharmaceutical environment, and offers neew ans state-of-the-art sections on medical devices, regulation standards, validation procedures, and automated system dvelopments.