Agalloco / Akers Advanced Aseptic Processing Technology

1. Auflage 2013
ISBN: 978-1-4398-2544-0
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 496 Seiten

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.

Autoren/Hrsg.

Agalloco, James

Akers, James

Fachgebiete

• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie

Inhaltsverzeichnis

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

Über Autor(innen)

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.