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Home > Science, Technology & Agriculture > Industrial chemistry and manufacturing technologies > Industrial chemistry and chemical engineering > Pharmaceutical chemistry and technology > Validation of Pharmaceutical Processes: Sterile Products, Second Edition
Validation of Pharmaceutical Processes: Sterile Products, Second Edition

Validation of Pharmaceutical Processes: Sterile Products, Second Edition


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About the Book

Details the design of systems, qualification of equipment, callibration and certification, and explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. The book contains new chapters on installation qualification, operational qualification, and change control; F, D and Z values; steam-sterilization-in-place technology and validation; and disinfectants.

Table of Contents:
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

Review :
"easy to read and informative.an excellent blend of theoretical knowledge and applied practical considerations." -American Journal of Pharmaceutical Education "this comprehensive bookwillprove very useful to those designing a facility for producing sterile and nonsterile productsa 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 Promo Copy


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Product Details
  • ISBN-13: 9780824793845
  • Publisher: Taylor & Francis Inc
  • Publisher Imprint: Marcel Dekker Inc
  • Edition: New edition
  • Language: English
  • No of Pages: 856
  • Sub Title: Sterile Products, Second Edition
  • Width: 178 mm
  • ISBN-10: 0824793846
  • Publisher Date: 05 Nov 1998
  • Binding: Hardback
  • Height: 254 mm
  • No of Pages: 856
  • Returnable: N
  • Weight: 1565 gr


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