Ebook Validation of Pharmaceutical Processes: Sterile Products, Second Edition, by F. J. Carleton, J. P. Agalloco, Carleton
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Validation of Pharmaceutical Processes: Sterile Products, Second Edition, by F. J. Carleton, J. P. Agalloco, Carleton
Ebook Validation of Pharmaceutical Processes: Sterile Products, Second Edition, by F. J. Carleton, J. P. Agalloco, Carleton
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Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program, and suggested solutions.
- Sales Rank: #2964011 in Books
- Published on: 1998-11-05
- Original language: English
- Number of items: 1
- Dimensions: 1.80" h x 7.12" w x 10.32" l, 3.28 pounds
- Binding: Hardcover
- 856 pages
Review
…easy to read and informative….an excellent blend of theoretical knowledge and applied practical considerations.
-American Journal of Pharmaceutical Education
…this comprehensive book…will…prove very useful to those designing a facility for producing sterile and nonsterile products…a good mix of the theoretical and applied.
-Irish Pharmacy Journal
…an excellent presentation on the subject of validation of pharmaceutical processes related to sterile products. It is written in a simple language and can be easily understood at the same time without losing the importance of the subject. The book will be an asset to education institutions in pharmacy and pharmaceutical technology, project and manufacturing personnel of sterile product manufacturing organisations and also to quality assurance and R&D personnel.
-Pharmatimes
…overwhelmingly valuable to anyone who has anything at all to do with the manufacture of sterile products, or with the processes associated with their production.
- Pharmaceutical Development and Technology
Most helpful customer reviews
1 of 1 people found the following review helpful.
Very Good
By Bill
I thought this book was excellent, it was exactly what I was looking for in terms of sterile products validation
0 of 2 people found the following review helpful.
Validation of medical devices?
By A Customer
I was looking for more information on medical devices than was provided and greater detail on the statistical methodology used to validate which was especially sketchy, especially at such a steep price.
0 of 0 people found the following review helpful.
Five Stars
By Erica Castillo
Informative
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