Validation of Pharmaceutical Processes
Marcel Dekker Inc (Verlag)
978-0-8247-9384-5 (ISBN)
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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.
INTRODUCTION
Why Validation?, Robert G. Kieffer and Joseph D. Nally
Organizing for Validation, Ronald J. Simko
Validation and Facility Design, J. Robert Adamson
SUPPORT AND UTILITY SYSTEMS
Calibration and Certification, Robert E. Bremmer
Design, Installation, and Calibration of Thermocouple Measuring Systems, Clarence A. Kemper
Qualification and Change Control, Bohdan M. Ferenc
Monitoring of Nonviable Particles, Alvin Lieberman
Viable Environmental Microbiological Monitoring, Pamela D. Deschenes
Validation of Environmental Control Systems Used in Parenteral Facilities, Franco De Vecchi
Validation of Utilities, Barry D. Garfinkle
The Validation of Pharmaceutical Water Systems, Theodore H. Meltzer
STERILIZATION, SANITIZATION, AND STERILITY ASSURANCE
Microbiology of Sterilization Processes, Timothy J. Leahy, Kerry L. Roche, and Maura R. Christopher
F, D, and Z Values, John Shirtz
Validation of Steam Sterilization in Autoclaves, Phil DeSantis
Steam Sterilization-in-Place Technology and Validation, James P. Agalloco
Dry-Heat Sterilization and Depyrogenation, Laurie B. Colman and Gayle D. Heffernan
Validation of Gas Sterilization, David F. Bekus
Validation of Radiation Sterilization Processes, John F. Reger
Validation of Sterilizing-Grade Filters, John McGrath and Richard Levy
Validation of Unique Filtration Processes, Carole S. Genovesi
Disinfectants, James D. Wilson
Cleaning and Sanitization of Cleanrooms and Materials, Anne Marie Dixon
Validation of Aseptic Processing, James P. Agalloco and James E. Akers
STERILE PRODUCT MANUFACTURING
Component Preparation Processes, Dominic A. Ventura and Stephen W. Goodsir
Validation of Lyophilization, Edward H. Trappler
Validation of Packaging Operations, Charles S. Levine
Retrospective Validation, James P. Agalloco
Regulatory Aspects of Validation, Ralph Badagliacca
Process Control and Quality Systems for a Changing World, James E. Akers
| Erscheint lt. Verlag | 5.11.1998 |
|---|---|
| Verlagsort | New York |
| Sprache | englisch |
| Maße | 178 x 254 mm |
| Gewicht | 1565 g |
| Themenwelt | Technik |
| ISBN-10 | 0-8247-9384-6 / 0824793846 |
| ISBN-13 | 978-0-8247-9384-5 / 9780824793845 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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