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Advanced aseptic processing technology

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Advanced aseptic processing technology/ edited by James Agalloco, James Akers.
其他作者:	Agalloco, James,
出版者:	London :Informa Healthcare, : c2010.,
面頁冊數:	xi, 481 p. :ill.
內容註:	1. An introduction to advanced aseptic processing technology / James Agalloco and James Akers -- 2. Getting started, establishing an aseptic processing systems technology group / Amnon Eylath -- 3. Aseptic processing facility design / Sterling Kline -- 4. Innovations in aseptic processing technology / James Agalloco and James Akers -- 5. Ergonomics in enclosure design / Brian Smith and David Pallister -- 6. Design and engineering--containing applications / Brian Smith and David Pallister -- 7. Design and engineering of isolators / Didier Meyer -- 8. Definition of restricted access barrier systems / J�org Zimmermann -- 9. Rapid transfer port system : the key element for contained enclosures in advanced aseptic processing / Brigitte Lechiffre and David Barbault -- 10. Aseptic processing transfer systems / Gary Partington -- 11. Disposable equipment in advanced aseptic technology / Maik W. Jornitz and Jean-Marc Cappia -- 12. A comparison of capital and operating costs for aseptic manufacturing facilities / Jorge Ferreira, Beth Holden, Jeff Kraft, and Kevin Schreier -- 13. Risk assessment and mitigation in aseptic processing / James Agalloco and James Akers -- 14. Sterile product manufacture using form fill seal technologies / Harold Baseman -- 15. Genesis of the closed vial technology / Daniel Py and Angela Turner -- 16. Aseptic containment / Julian Wilkins -- 17. Points to consider in the design of a filling isolator / Valerie Welter -- 18. Sterility test isolators-a user's perspective / Robert J. Keller -- 19. Advanced aseptic processing fill finish trends : options to consider, restricted access barrier systems, and/or isolators / Jack Lysfjord -- 20. Process simulation for advanced aseptic processing / James Agalloco and James Akers -- 21. Qualification/validation of aseptic processing environments, systems, and equipment / James Agalloco -- 22. Isolator integrity leak inspection / Scott Pool -- 23. Environmental monitoring of advanced aseptic processing technology / James Akers and James Agalloco -- 24. Decontamination of advanced aseptic processing environments / James Agalloco and James Akers -- 25. Hydrogen peroxide gas decontamination / James R. Rickloff -- 26. Isolation technology : hydrogen peroxide decontamination / David Watling -- 27. Single-injection vapor-phase hydrogen peroxide decontamination of isolators and clean rooms / Kunihiro Imai, Souma Watanabe, Yasusuke Oshima, Mamoru Kokubo, and James Akers -- 28. Chlorine dioxide decontamination/sterilization / Mark A. Czarneski -- 29. Current expectations for aseptic processing : a regulatory perspective / Richard L. Friedman -- 30. The evolution of advanced aseptic processing for pharmaceutical manufacturing : perspectives of a regulatory scientist / David Hussong -- 31. A perspective on European regulations for advanced aseptic processing / James Agalloco and James Akers -- 32. Advanced aseptic processing technologies in Japan / Tsuguo Sasaki and Morihiko Takeda -- 33. Pilot plants and isolation technology / James Agalloco -- 34. Highly automated isolator-based vaccine filling : a case study / James Akers, Kazuhito Tanimoto, and Masahito Kawata -- 35. Technological advancements in aseptic processing and the elimination of contamination risk / James Akers and Yoshi Izumi -- 36. Radiopharmaceutical filling line / Frank Mastromonica and Simon Steingart -- 37. Powder handling installation for high potent bulk pharmaceutical ingredients / Bert Brabants -- 38. Isolator technology for aseptic filling of anti-cancer drugs / Paul Martin -- 39. RABS case study / J�org Zimmermann -- 40. Innovation in aseptic processing : case study through the development of a new technology / Beno�it Verjans -- 41. Isolated robotics / Christopher Procyshyn -- 42. The future of aseptic processing / James Agalloco and James Akers.
標題:	Asepsis and antisepsis. -
電子資源:	http://marc.crcnetbase.com/isbn/9781439825440Distributed by publisher. Purchase or institutional license may be required for access.
ISBN:	9781439825440 (ebook : PDF)

Advanced aseptic processing technology
Advanced aseptic processing technology[electronic resource] /edited by James Agalloco, James Akers. - London :Informa Healthcare,c2010. - xi, 481 p. :ill. - Drugs and the pharmaceutical sciences. - Drugs and the pharmaceutical sciences..

Includes bibliographical references and index.

1. An introduction to advanced aseptic processing technology / James Agalloco and James Akers -- 2. Getting started, establishing an aseptic processing systems technology group / Amnon Eylath -- 3. Aseptic processing facility design / Sterling Kline -- 4. Innovations in aseptic processing technology / James Agalloco and James Akers -- 5. Ergonomics in enclosure design / Brian Smith and David Pallister -- 6. Design and engineering--containing applications / Brian Smith and David Pallister -- 7. Design and engineering of isolators / Didier Meyer -- 8. Definition of restricted access barrier systems / J�org Zimmermann -- 9. Rapid transfer port system : the key element for contained enclosures in advanced aseptic processing / Brigitte Lechiffre and David Barbault -- 10. Aseptic processing transfer systems / Gary Partington -- 11. Disposable equipment in advanced aseptic technology / Maik W. Jornitz and Jean-Marc Cappia -- 12. A comparison of capital and operating costs for aseptic manufacturing facilities / Jorge Ferreira, Beth Holden, Jeff Kraft, and Kevin Schreier -- 13. Risk assessment and mitigation in aseptic processing / James Agalloco and James Akers -- 14. Sterile product manufacture using form fill seal technologies / Harold Baseman -- 15. Genesis of the closed vial technology / Daniel Py and Angela Turner -- 16. Aseptic containment / Julian Wilkins -- 17. Points to consider in the design of a filling isolator / Valerie Welter -- 18. Sterility test isolators-a user's perspective / Robert J. Keller -- 19. Advanced aseptic processing fill finish trends : options to consider, restricted access barrier systems, and/or isolators / Jack Lysfjord -- 20. Process simulation for advanced aseptic processing / James Agalloco and James Akers -- 21. Qualification/validation of aseptic processing environments, systems, and equipment / James Agalloco -- 22. Isolator integrity leak inspection / Scott Pool -- 23. Environmental monitoring of advanced aseptic processing technology / James Akers and James Agalloco -- 24. Decontamination of advanced aseptic processing environments / James Agalloco and James Akers -- 25. Hydrogen peroxide gas decontamination / James R. Rickloff -- 26. Isolation technology : hydrogen peroxide decontamination / David Watling -- 27. Single-injection vapor-phase hydrogen peroxide decontamination of isolators and clean rooms / Kunihiro Imai, Souma Watanabe, Yasusuke Oshima, Mamoru Kokubo, and James Akers -- 28. Chlorine dioxide decontamination/sterilization / Mark A. Czarneski -- 29. Current expectations for aseptic processing : a regulatory perspective / Richard L. Friedman -- 30. The evolution of advanced aseptic processing for pharmaceutical manufacturing : perspectives of a regulatory scientist / David Hussong -- 31. A perspective on European regulations for advanced aseptic processing / James Agalloco and James Akers -- 32. Advanced aseptic processing technologies in Japan / Tsuguo Sasaki and Morihiko Takeda -- 33. Pilot plants and isolation technology / James Agalloco -- 34. Highly automated isolator-based vaccine filling : a case study / James Akers, Kazuhito Tanimoto, and Masahito Kawata -- 35. Technological advancements in aseptic processing and the elimination of contamination risk / James Akers and Yoshi Izumi -- 36. Radiopharmaceutical filling line / Frank Mastromonica and Simon Steingart -- 37. Powder handling installation for high potent bulk pharmaceutical ingredients / Bert Brabants -- 38. Isolator technology for aseptic filling of anti-cancer drugs / Paul Martin -- 39. RABS case study / J�org Zimmermann -- 40. Innovation in aseptic processing : case study through the development of a new technology / Beno�it Verjans -- 41. Isolated robotics / Christopher Procyshyn -- 42. The future of aseptic processing / James Agalloco and James Akers.

Mode of access: World Wide Web.

ISBN: 9781439825440 (ebook : PDF)Subjects--Topical Terms:

867287
Asepsis and antisepsis.
Index Terms--Genre/Form:

542853
Electronic books.

Advanced aseptic processing technology
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245 0 0 $a Advanced aseptic processing technology $h [electronic resource] / $c edited by James Agalloco, James Akers.
260 $a London : $b Informa Healthcare, $c c2010.
300 $a xi, 481 p. : $b ill.
490 1 $a Drugs and the pharmaceutical sciences
504 $a Includes bibliographical references and index.
505 0 $a 1. An introduction to advanced aseptic processing technology / James Agalloco and James Akers -- 2. Getting started, establishing an aseptic processing systems technology group / Amnon Eylath -- 3. Aseptic processing facility design / Sterling Kline -- 4. Innovations in aseptic processing technology / James Agalloco and James Akers -- 5. Ergonomics in enclosure design / Brian Smith and David Pallister -- 6. Design and engineering--containing applications / Brian Smith and David Pallister -- 7. Design and engineering of isolators / Didier Meyer -- 8. Definition of restricted access barrier systems / J�org Zimmermann -- 9. Rapid transfer port system : the key element for contained enclosures in advanced aseptic processing / Brigitte Lechiffre and David Barbault -- 10. Aseptic processing transfer systems / Gary Partington -- 11. Disposable equipment in advanced aseptic technology / Maik W. Jornitz and Jean-Marc Cappia -- 12. A comparison of capital and operating costs for aseptic manufacturing facilities / Jorge Ferreira, Beth Holden, Jeff Kraft, and Kevin Schreier -- 13. Risk assessment and mitigation in aseptic processing / James Agalloco and James Akers -- 14. Sterile product manufacture using form fill seal technologies / Harold Baseman -- 15. Genesis of the closed vial technology / Daniel Py and Angela Turner -- 16. Aseptic containment / Julian Wilkins -- 17. Points to consider in the design of a filling isolator / Valerie Welter -- 18. Sterility test isolators-a user's perspective / Robert J. Keller -- 19. Advanced aseptic processing fill finish trends : options to consider, restricted access barrier systems, and/or isolators / Jack Lysfjord -- 20. Process simulation for advanced aseptic processing / James Agalloco and James Akers -- 21. Qualification/validation of aseptic processing environments, systems, and equipment / James Agalloco -- 22. Isolator integrity leak inspection / Scott Pool -- 23. Environmental monitoring of advanced aseptic processing technology / James Akers and James Agalloco -- 24. Decontamination of advanced aseptic processing environments / James Agalloco and James Akers -- 25. Hydrogen peroxide gas decontamination / James R. Rickloff -- 26. Isolation technology : hydrogen peroxide decontamination / David Watling -- 27. Single-injection vapor-phase hydrogen peroxide decontamination of isolators and clean rooms / Kunihiro Imai, Souma Watanabe, Yasusuke Oshima, Mamoru Kokubo, and James Akers -- 28. Chlorine dioxide decontamination/sterilization / Mark A. Czarneski -- 29. Current expectations for aseptic processing : a regulatory perspective / Richard L. Friedman -- 30. The evolution of advanced aseptic processing for pharmaceutical manufacturing : perspectives of a regulatory scientist / David Hussong -- 31. A perspective on European regulations for advanced aseptic processing / James Agalloco and James Akers -- 32. Advanced aseptic processing technologies in Japan / Tsuguo Sasaki and Morihiko Takeda -- 33. Pilot plants and isolation technology / James Agalloco -- 34. Highly automated isolator-based vaccine filling : a case study / James Akers, Kazuhito Tanimoto, and Masahito Kawata -- 35. Technological advancements in aseptic processing and the elimination of contamination risk / James Akers and Yoshi Izumi -- 36. Radiopharmaceutical filling line / Frank Mastromonica and Simon Steingart -- 37. Powder handling installation for high potent bulk pharmaceutical ingredients / Bert Brabants -- 38. Isolator technology for aseptic filling of anti-cancer drugs / Paul Martin -- 39. RABS case study / J�org Zimmermann -- 40. Innovation in aseptic processing : case study through the development of a new technology / Beno�it Verjans -- 41. Isolated robotics / Christopher Procyshyn -- 42. The future of aseptic processing / James Agalloco and James Akers.
530 $a Also available in print edition.
538 $a Mode of access: World Wide Web.
650 0 $a Asepsis and antisepsis. $3 867287
650 0 $a Medical instruments and apparatus $x Sterilization. $3 794732
655 7 $a Electronic books. $2 lcsh $3 542853
700 1 $a Agalloco, James, $d 1948- $3 2121997
700 1 $a Akers, James E. $3 1603121
776 1 $z 9781439825433
830 0 $a Drugs and the pharmaceutical sciences. $3 1603217
856 4 0 $u http://marc.crcnetbase.com/isbn/9781439825440 $q application/PDF $z Distributed by publisher. Purchase or institutional license may be required for access.