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Book Cover
E-book
Author Akers, Michael J

Title Sterile drug products : formulation, packaging, manufacturing, and quality / Michael J. Akers
Published New York : Informa Healthcare, 2010
Online access available from:
Taylor and Francis ebooks    View Resource Record  

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Description 1 online resource (ix, 505 pages) : illustrations
Series Drugs and the pharmaceutical sciences
Drugs and the pharmaceutical sciences.
Contents 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 product development -- 6. Formulation components (solvents and solutes) -- 7. Sterile products packaging chemistry -- 8. Formulation and stability of solutions -- 9. Dispersed systems -- 10. Formulation of freeze-dried powders -- 11. Overcoming formulation problems and some case studies -- 12. Overview of sterile product manufacturing -- 13. Contamination control -- 14. Sterile manufacturing facilities -- 15. Water and air quality in sterile manufacturing facilities -- 16. Personnel requirements for sterile manufacturing -- 17. Sterilization methods in sterile product manufacturing -- 18. Sterile filtration -- 19. Sterile product filling, stoppering, and sealing -- 20. Freeze-dry (lyophilization) processing -- 21. Aseptic processing -- 22. Inspection, labeling, and 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. Microorganisms and sterility testing -- 28. Pyrogens and pyrogen/endotoxin testing -- 29. Particles and particulate matter testing -- 30. Sterile product-package integrity testing -- 31. Administration of injectable drug products -- 32. Clinical hazards of injectable drug administration -- 33. Biopharmaceutical considerations with injectable drug delivery
Summary 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. This is an
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Drugs -- Sterilization.
Quality control.
Dosage Forms -- standards
Quality Control
Sterilization -- standards
Technology, Pharmaceutical -- standards
quality control.
MEDICAL -- Drug Guides.
MEDICAL -- Pharmacology.
MEDICAL -- Pharmacy.
MEDICAL -- Nursing -- Pharmacology.
Quality control
Drugs -- Sterilization
Form Electronic book
ISBN 9781420020564
1420020560