Advanced Aseptic Processing Technology

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Advanced Aseptic Processing Technology

By James P. Agalloco and James Akers

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Published: July 2010
ISBN: 9781439825433
eISBN: 9781439825440
First Edition
800 pages
Format: Hardcover
Size: 7 x 10 inches
100 Black and White Illustrations

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This book is intended to provide complete coverage of emerging aseptic processing technology, in particular those technologies that are reshaping the production of sterile healthcare products including: isolators, restricted access barrier systems, robotics, disposables and others.

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The authors are active in this area on almost a daily basis, and frequently find it necessary to explain the considerations associated with these newer technological advances to audiences that are largely unfamiliar or uncomfortable with them. The new ideas and adaptations of older technologies that have emerged have had a profound impact on the global healthcare industry. In important ways the industry has fallen behind other clean and aseptic industries in process design and control and this book helps point the way forward. To bridge the gap between practices associated with more conventional aseptic processing, this book outlines the transformation of concepts and practices into the next generation of aseptic processing.

The book is an ambitious undertaking particularly in an area experiencing continual innovation. This challenge is made even greater when a very well defined and rather rigid collection of process control strategies have for cleanroom based technologies. There has been a great temptation to bring these well-understood principles, which form the cornerstone of regulatory guidance in the area of aseptic processing into the separative technology era. It is time to rethink the approach to aseptic process control away from the heavy emphasis on microbiological monitoring that has prevailed in clean rooms to other approaches that will require a profound paradigm shift. The shift will take us from confirmation of acceptable environmental conditions through extensive monitoring of manned environments to installations where environmental control is accomplished by the elimination of contamination sources. Far more can be accomplished by designing the contamination out of the system, than by endeavoring to demonstrate its absence through extensive sampling and analysis

Preface
1. An Introduction to Advanced Aseptic Processing Technology
2. Getting Started, Establishing an Aseptic Processing Systems Technology Group
3. Aseptic Processing Facility Design
4. Innovations in Aseptic Processing Technology
5. Ergonomics in Enclosure Design
6. Design & Engineering of Enclosures for Containment Applications
7. Design and Engineering of Isolators
8. Definition of Restricted Access Barrier Systems
9. Rapid Transfer Port Systems
10. Aseptic Processing Transfer Systems
11. Disposable Equipment in Aseptic Technology
12. A Comparison of Capital and Operating Costs for Aseptic Manufacturing Facilities
13. Risk Assessment and Mitigation in Aseptic Processing
14. Sterile Product Manufacture Using Form Fill Seal Technologies
15. Genesis of the Closed Vial Technology
16. Aseptic Containment
17. Points to Consider - Filling Isolator
18. Sterility Test Isolators- A User’s Perspective
19. Advanced Aseptic Processing Fill Finish Trends
20. Process Simulation for Advanced Aseptic Processing
21. Qualification / Validation of Aseptic Processing Environments, Systems & Equipment
22. Isolator Integrity Leak Inspection
23. Environmental Monitoring of Advanced Aseptic Processing
24. Decontamination of Advanced Aseptic Processing Environments
25. Hydrogen Peroxide Gas Decontamination
26. Isolation Technology: Hydrogen Peroxide Decontamination
27. Single Injection Vapor Phase Hydrogen Peroxide Decontamination of Isolators and Cleanrooms
28. Chlorine Dioxide Decontamination / Sterilization
29. FDA Regulatory Perspective
30. The Evolution of Advanced Aseptic Processing for Pharmaceutical Manufacturing: Perspectives of a Regulatory Scientist
31. A Perspective on European Regulations for Advanced Aseptic Processing
32. Advanced Aseptic Processing Technologies in Japan
33. Pilot Plants and Isolation Technology
34. High Speed Aseptic Filling
35. Kit Assembly
36. Radiopharmaceutical Filling Line
37. Powder handling installation for high potent bulk pharmaceutical ingredients
38. Isolator Technology for Aseptic Filling of Anti-Cancer Drugs
39. RABS Case Study
40. Innovation in Aseptic Processing: Case Study through the Development of a New Technology
41. Isolated Robotics
42. The Future of Aseptic Processing

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.

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