دانلود کتاب Advanced aseptic processing technology

Content: 1. An introduction to advanced aseptic processing technology James P. Agalloco and James E. 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 P. Agalloco and James E. Akers 5. Ergonomics in enclosure design Brian Smith and David Pallister 6. Design and engineering-containment applications Brian Smith and David Pallister 7. Design and engineering of isolators Didier Meyer 8. Definition of restricted access barrier systems Joerg 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 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 P. 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 K. Imai, S. Watanabe, Y. Oshima, M. Kokubo, and J. Akers 28. Chlorine dioxide decontamination/sterilization Mark A. Czarneski 29. Current expectations for aseptic processing: a regulatory perspective Rick 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 P. Agalloco and James E. Akers 32. Advanced aseptic processing technologies in Japan Tsuguo Sasaki and Morihiko Takeda 33. Pilot plants and isolation technology James P. Agalloco 34. Highly automated isolator-based vaccine filling-a case study James Akers, Shibuya Kogyo, and Handei Bekin 35. Technological advancements in aseptic processing and the elimination of contamination risk James E. 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 Joerg Zimmermann 40. Innovation in aseptic processing: case study through the development of a new technology Benoit Verjans 41. Isolated robotics Chris Procyshyn 42. The future of aseptic processing James P. Agalloco and James E. Akers