The Resource Sterile drug products : formulation, packaging, manufacturing, and quality, Michael J. Akers

Sterile drug products : formulation, packaging, manufacturing, and quality, Michael J. Akers

Label
Sterile drug products : formulation, packaging, manufacturing, and quality
Title
Sterile drug products
Title remainder
formulation, packaging, manufacturing, and quality
Statement of responsibility
Michael J. Akers
Creator
Subject
Language
eng
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
Member of
Cataloging source
N$T
Dewey number
615/.1
Illustrations
illustrations
Index
index present
LC call number
RS199.S73
LC item number
A44 2010eb
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Series statement
Drugs and the pharmaceutical sciences
Label
Sterile drug products : formulation, packaging, manufacturing, and quality, Michael J. Akers
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
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
Control code
ocn676696292
Dimensions
unknown
Extent
1 online resource (ix, 505 pages)
File format
unknown
Form of item
online
Isbn
9781420020564
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations
Quality assurance targets
not applicable
http://library.link/vocab/recordID
.b25030735
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
  • (OCoLC)676696292
  • pebc1420020560

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
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