Validation of Pharmaceutical Processes: Sterile Products, Second Edition - Rilegato

Rilegato

ISBN 10: 0824793846 ISBN 13: 9780824793845

Casa editrice: CRC Press, 1998

Riassunto

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.

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Contenuti

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

Dettagli dell'edizione

• Editore: CRC Press
• Data di pubblicazione: 1998
• Lingua: Inglese
• ISBN 10: 0824793846
• ISBN 13: 9780824793845
• Rilegatura: Copertina rigida
• Numero edizione: 2
• Numero di pagine: 856
• Redattore: Carleton Frederick J., Agalloco James P.
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile