Advanced Aseptic Processing Technology  book cover
1st Edition

Advanced Aseptic Processing Technology

ISBN 9781439825433
Published July 23, 2010 by CRC Press
496 Pages 100 B/W Illustrations

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Book Description

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.

Table of Contents

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

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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.