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Başlık:
Advanced aseptic processing technology
Yazar:
Agalloco, James, 1948-
ISBN:
9781439825440
Yayın Bilgileri:
London : Informa Healthcare, c2010.
Fiziksel Tanımlama:
xi, 481 p. : ill.
Seri:
Drugs and the pharmaceutical sciences
Seri Başlığı:
Drugs and the pharmaceutical sciences
İçerik:
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 / Jr̲g 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 / Jr̲g Zimmermann -- 40. Innovation in aseptic processing : case study through the development of a new technology / Benot̋ Verjans -- 41. Isolated robotics / Christopher Procyshyn -- 42. The future of aseptic processing / James Agalloco and James Akers.
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