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

Read More: http://informahealthcare.com/doi/book/10.3109/9781420020564