求助英文书Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality By Michael J. Akers
Available to Purchase
Publisher:
Informa Healthcare
Published: August 2010
ISBN: 9780849339936
eISBN: 9781420020564
First Edition
536 pages
Format: Hardcover
Size: 7"x10"
Quick Overview
Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common.
1. Introduction, Scope, and History of Sterile Products
2. Characteristics of Sterile Dosage Forms
3. Types of Sterile Dosage Forms
4. Sterile Product Packaging Systems
5. Overview of Sterile Product Development
6. Formulation Components--Solvents and Solutes
7. Sterile Products Packaging Chemistry
8. Formulation and Stability of Solutions
9. Formulation of Dispersed Systems
10. Formulation of Freeze-Dried Powders
11. Overcoming Formulation Problems
12. Overview of Sterile Product Manufacturing
13. Contamination Control
14. Sterile Manufacturing Facilities
15. Water and Air Quality in Sterile Product Manufacturing
16. Personnel Requirements in Sterile Product Manufacturing
17. Sterilization Methods in Sterile Product Manufacturing
18. Sterile Filtration
19. Sterile Product Filling, Stoppering, and Sealing
20. Freeze-Dry Processing--Lyophilization
21. Aseptic Processing
22. Inspection, Labelling, Secondary Packaging
23. Barrier and Other Advanced Technologies in Aseptic Processing
24. Stability, Storage, and Distribution of Sterile Drug Products
25. Good Manufacturing Practice
26. Quality Assurance and Control
27. Sterility Testing
28. Pyrogens and Pyrogen/Endotoxin Testing
29. Particulate Matter Testing
30. Sterile Package Integrity Testing
31. Administration of Injectable Drug Products
32. Clinical Hazards of Injectable Drug Administration
33. Biopharmaceutical Considerations with Injectable Drug Delivery
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