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.