ABSTRACT

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, proce

chapter 9|17 pages

Airborne Contamination Control

chapter 11|54 pages

Sterile Filtration

chapter 14|8 pages

Raw Material Contamination Control

chapter 18|21 pages

Statistical Sampling Concepts

chapter 21|35 pages

Simulation of Aseptic Manufacture