Advanced Aseptic Processing Technology

ISBN-13: 9781439825433 / Angielski / Twarda / 2010 / 496 str.

James P. Agalloco; James Akers

Opis

Advanced Aseptic Processing Technology

Spis treści

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

Benoˆıt Verjans

41. Isolated robotics

Chris Procyshyn

42. The future of aseptic processing

James P. Agalloco and James E. Akers