1st Edition

Advanced Aseptic Processing Technology

Edited By James Agalloco, James Akers Copyright 2010
    496 Pages 100 B/W Illustrations
    by CRC Press

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    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

    Benoˆıt 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.