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Sterile drug products = formulation,...

Akers, Michael J.

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Sterile drug products = formulation, packaging, manufacturing, and quality /

Record Type:	Electronic resources : Monograph/item
Title/Author:	Sterile drug products/ Michael J. Akers.
Reminder of title:	formulation, packaging, manufacturing, and quality /
Author:	Akers, Michael J.
Published:	New York :Informa Healthcare, : 2010.,
Description:	ix, 505 p. :ill.
[NT 15003449]:	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.
Subject:	Drugs - Sterilization. -
Online resource:	http://marc.crcnetbase.com/isbn/9781420020564Distributed by publisher. Purchase or institutional license may be required for access.
ISBN:	9781420020564 (ebook : PDF)

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

Sterile drug productsformulation, packaging, manufacturing, and quality /[electronic resource] :Michael J. Akers. - New York :Informa Healthcare,2010. - ix, 505 p. :ill. - Drugs and the pharmaceutical sciences. - Drugs and the pharmaceutical sciences..

Includes bibliographical references and index.

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.

Mode of access: World Wide Web.

ISBN: 9781420020564 (ebook : PDF)Subjects--Topical Terms:

915655
Drugs
--Sterilization.Index Terms--Genre/Form:

542853
Electronic books.

Sterile drug products = formulation, packaging, manufacturing, and quality /
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020 $a 9781420020564 (ebook : PDF)
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090 $a RS199.S73 $b A44 2010
092 $a 615.1 $b A315
100 1 $a Akers, Michael J. $3 661538
245 1 0 $a Sterile drug products $h [electronic resource] : $b formulation, packaging, manufacturing, and quality / $c Michael J. Akers.
260 $a New York : $b Informa Healthcare, $c 2010.
300 $a ix, 505 p. : $b ill.
490 1 $a Drugs and the pharmaceutical sciences
504 $a Includes bibliographical references and index.
505 0 $a 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.
530 $a Also available in print edition.
538 $a Mode of access: World Wide Web.
650 0 $a Drugs $x Sterilization. $3 915655
655 7 $a Electronic books. $2 lcsh $3 542853
776 1 $z 9780849339936 (hb : alk. paper) $z 0849339936 (hb : alk. paper)
830 0 $a Drugs and the pharmaceutical sciences. $3 1603217
856 4 0 $u http://marc.crcnetbase.com/isbn/9781420020564 $q application/PDF $z Distributed by publisher. Purchase or institutional license may be required for access.