Microbial Contamination Control in Parenteral Manufacturing 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.

Partial Contents

1. Historical and Emerging Themes in Parenteral Manufacturing Contamination Control
2. Microbial Contamination Hazard Analysis in Sterile Product Manufacturing
3. Overview of Modern Parenteral Processes
4. The Role of USP in the Microbiological Assessment of Parenteral Manufacturing
5. Sterile Concepts and Bioindicators
6. Biological Safety Cabinets and Isolators Used in Pharmaceutical Processing
7. Developing a Process for Aseptic Facility Design and Validation
8. Pharmaceutical Water Systems: New Orientations in System Design
9. Airborne Contamination Control
10. Disinfection Practices in Parenteral Manufacturing
11. Sterile Filtration
12. Process Development of Alternative Sterilization Methods
13. Terminal Sterilization and Parametric Release

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