Advanced Aseptic Processing Technology - Couverture rigide

Couverture rigide

ISBN 10 : 1439825432 ISBN 13 : 9781439825433

Editeur : CRC Press Inc, 2010

Synopsis

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. 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

A propos du livre

Biographie de l'auteur :

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.

Présentation de l'éditeur :

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.

À propos de cette édition

• Éditeur: CRC Press Inc
• Date d'édition: 2010
• ISBN 10: 1439825432
• ISBN 13: 9781439825433
• Reliure: Relié
• Numéro d'édition: 1
• Nombre de pages: 494