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.
- ISBN10 0203021363
- ISBN13 9780203021361
- Publish Date 14 May 2014 (first published 20 May 2004)
- Publish Status Active
- Publish Country US
- Publisher Taylor & Francis Inc
- Imprint CRC Press Inc
- Format eBook
- Pages 764
- Language English