Leads readers through the multitude of tasks involved in the
control of microbiological contamination in the production of
parenteral drugs. 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.
General
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