| Description |
1 online resource (760 pages) |
| Series |
Drugs and the Pharmaceutical Sciences |
|
Drugs and the pharmaceutical sciences
|
| Contents |
Book Cover -- Half-Title -- Title -- Copyright -- Preface -- Contents -- Contributors -- 1. Historical and Emerging Themes in Parenteral Manufacturing Contamination Control -- 2. Microbial Origins, Microbiological Function, and Contamination Hazard Analysis in Sterile Product Manufacturing -- 3. Overview of Modern Parenteral Products and Processes -- 4. The Role of USP in the Microbiological Assessment of Parenteral Manufacturing -- 5. Sterility 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 -- 14. Raw Material Contamination Control -- 15. Endotoxin: Worst-Case Parenteral Pyrogen -- 16 Screening Active Pharmaceutical Ingredients and Excipients for Endotoxin -- 17 Viral and Prion Clearance Strategies for Biopharmaceutical Safety -- 18 Statistical Sampling Concepts -- 19 Environmental Monitoring -- 20 Prevention and Troubleshooting of Microbial Excursions -- 21 Simulation of Aseptic Manufacture -- 22 Standard Methods of Microbial Identification -- 23 Rapid Methods of Microbial Identification -- Index |
| Summary |
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 |
| Notes |
Publisher supplied metadata and other sources |
| Subject |
Parenteral solutions -- Contamination.
|
|
Parenteral solutions -- Quality control
|
|
Parenteral solutions -- Contamination
|
|
Parenteral solutions -- Quality control
|
| Form |
Electronic book
|
| ISBN |
9780824751708 |
|
0824751701 |
|
