Advanced Aseptic Processing Technology

The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies for aseptic processing that will markedly reduce the level of contamination risk for sterile products and includes coverage on: The use of isolator and barrier concepts for aseptic processing and assembly. The application of robotics as an alternative to gowned personnel. The increasing reliance on automation to minimize or eliminate operator intervention. The design, operational, monitoring and compliance changes necessary for success with advanced aseptic processing. Advanced Aseptic Processing Technology is an essential reference for anyone working with sterile products, and is recommended for individuals in manufacturing,, compliance, regulatory affairs, microbiology, environmental monitoring, sterility testing, sterilization, validation, engineering, development, facility and equipment design, component and equipment suppliers, automation, and robotics.

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 Benoˆit Verjans 41. Isolated robotics Chris Procyshyn 42. The future of aseptic processing James P. Agalloco and James E. Akers

James Agalloco is President of Agalloco & Associates. Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 100 firms in the areas of validation, sterilization, aseptic processing and compliance. . He is a past President of the Parenteral Drug Association and a member of United States Pharmacopeia’s Microbiology and Sterility Assurance Expert Committee since 2005. He has authored or co-authored 43 book chapters and over 100 papers, and has lectured extensively on process validation, aseptic processing, sterilization and isolation technology at various industry meetings, domestically as well as internationally. He also co-edited the book Validation of Pharmaceutical Processes, 3rd edition, Informa Healthcare, 2007. James E. Akers Ph.D. is President and Co-Owner of Akers Kennedy & Associates and a Technical Consultant to Shibuya Kogyo, Co. LTD. Dr Akers received his BA in Biology from the University of Kansas in 1971 and his Ph.D. in Medical Microbiology from the University of Kansas, School of Medicine in 1976. He is past president of the Parenteral Drug Association (PDA) and has participated on many PDA Task Forces. He has written over 100 articles and 28 book chapters on subjects including aseptic processing, validation, biologics manufacturing, isolation technology, and environmental monitoring. Dr Akers is a Chairman of the Microbiology and Sterility Assurance Committee of Experts for the United States Pharmacopeia and has 35 years of experience working in, evaluating and providing design input for clean environments used in research and manufacturing applications.