Advanced Aseptic Processing Technology

1. An introduction to advanced aseptic processing technology 2. Getting started, establishing an aseptic processing systems technology group 3. Aseptic processing facility design 4. Innovations in aseptic processing technology 5. Ergonomics in enclosure design 6. Design and engineering-containment applications 7. Design and engineering of isolators 8. Definition of restricted access barrier systems 9. Rapid transfer port system: the key element for contained enclosures in advanced aseptic processing 10. Aseptic processing transfer systems 11. Disposable equipment in advanced aseptic technology 12. A comparison of capital and operating costs for aseptic manufacturing facilities 13. Risk assessment and mitigation in aseptic processing 14. Sterile product manufacture using form fill seal technologies 15. Genesis of the closed vial technology 16. Aseptic containment 17. Points to consider filling isolator 18. Sterility test isolators-a user's perspective 19. Advanced aseptic processing fill finish trends: options to consider, restricted access barrier systems, and/or isolators 20. Process simulation for advanced aseptic processing 21. Qualification/validation of aseptic processing environments, systems, and equipment 22. Isolator integrity leak inspection 23. Environmental monitoring of advanced aseptic processing technology 24. Decontamination of advanced aseptic processing environments 25. Hydrogen peroxide gas decontamination 26. Isolation technology: hydrogen peroxide decontamination 27. Single-injection vapor-phase hydrogen peroxide decontamination of isolators and clean rooms 28. Chlorine dioxide decontamination/sterilization 29. Current expectations for aseptic processing: a regulatory perspective 30. The evolution of advanced aseptic processing for pharmaceutical manufacturing: perspectives of a regulatory scientist 31. A perspective on European regulations for advanced aseptic processing 32. Advanced aseptic processing technologies in Japan 33. Pilot plants and isolation technology 34. Highly automated isolator-based vaccine filling-a case study 35. Technological advancements in aseptic processing and the elimination of contamination risk 36. Radiopharmaceutical filling line 37. Powder handling installation for high potent bulk pharmaceutical ingredients 38. Isolator technology for aseptic filling of anti-cancer drugs 39. RABS case study 40. Innovation in aseptic processing: case study through the development of a new technology 41. Isolated robotics 42. The future of aseptic processing

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• Biologia, ciências da vida
• Engenharia: geral
• Tecnologia farmacêutica
• Indústria farmacêutica

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