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EBOOK
Title Validation of pharmaceutical processes : sterile products / edited by Frederick J. Carleton, James P. Agalloco.
Imprint New York : M. Dekker, 1999.
Edition 2nd ed., rev. and expanded.

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Subject Sterilization.
Pharmaceutical technology -- Quality control.
Pharmaceutical technology -- Standards.
Technology, Pharmaceutical.
Quality Control.
Sterilization -- methods.
Alt Name Carleton, Frederick J., 1925-
Agalloco, James P., 1948-
Alternate Title Validation of aseptic pharmaceutical processes.
Description 1 online resource (xii, 840 pages) : illustrations
Edition 2nd ed., rev. and expanded.
Note Revised edition of: Validation of aseptic pharmaceutical processes. c1986.
Bibliography Note Includes bibliographical references and index.
Note Print version record.
Contents 1. Why Validation? / Robert G. Kieffer and Joseph D. Nally -- 2. Organizing for Validation / Ronald J. Simko -- 3. Validation and Facility Design / J. Robert Adamson -- 4. Calibration and Certification / Robert E. Bremmer -- 5. Design, Installation, and Calibration of Thermocouple Measuring Systems / Clarence A. Kemper -- 6. Qualification and Change Control / Bohdan M. Ferenc -- 7. Monitoring of Nonviable Particles / Alvin Lieberman -- 8. Viable Environmental Microbiological Monitoring / Pamela D. Deschenes -- 9. Validation of Environmental Control Systems Used in Parenteral Facilities / Franco De Vecchi -- 10. Validation of Utilities / Barry D. Garfinkle -- 11. The Validation of Pharmaceutical Water Systems / Theodore H. Meltzer -- 12. Microbiology of Sterilization Processes / Timothy J. Leahy, Kerry L. Roche and Maura R. Christopher -- 13. F, D, and Z Values / John Shirtz -- 14. Validation of Steam Sterilization in Autoclaves / Phil DeSantis -- 15. Steam Sterilization-in-Place Technology and Validation / James P. Agalloco -- 16. Dry-Heat Sterilization and Depyrogenation / Laurie B. Colman and Gayle D. Heffernan -- 17. Validation of Gas Sterilization / David F. Bekus -- 18. Validation of Radiation Sterilization Processes / John F. Reger -- 19. Validation of Sterilizing-Grade Filters / John McGrath and Richard Levy -- 20. Validation of Unique Filtration Processes / Carole S. Genovesi -- 21. Disinfectants / James D. Wilson -- 22. Cleaning and Sanitization of Cleanrooms and Materials / Anne Marie Dixon -- 23. Validation of Aseptic Processing / James P. Agalloco and James E. Akers -- 24. Component Preparation Processes / Dominic A. Ventura and Stephen W. Goodsir -- 25. Validation of Lyophilization / Edward H. Trappler -- 26. Validation of Packaging Operations / Charles S. Levine -- 27. Retrospective Validation / James P. Agalloco -- 28. Regulatory Aspects of Validation / Ralph Badagliacca.
ISBN 0585134073 (electronic bk.)
9780585134079 (electronic bk.)
0824793846
OCLC # 44953676
Additional Format Print version: Validation of pharmaceutical processes. 2nd ed., rev. and expanded. New York : M. Dekker, 1999 0824793846 (DLC) 98044757 (OCoLC)39982679
Table of Contents
 Preface 
 Contributors 
1Why Validation? / Robert G. Kieffer, Joseph D. Nally1
2Organizing for Validation / Ronald J. Simko17
3Validation and Facility Design / J. Robert Adamson31
4Calibration and Certification / Robert E. Bremmer59
5Design, Installation, and Calibration of Thermocouple Measuring Systems / Clarence A. Kemper101
6Qualification and Change Control / Bohdan M. Ferenc131
7Monitoring of Nonviable Particles / Alvin Lieberman151
8Viable Environmental Microbiological Monitoring / Pamela D. Deschenes197
9Validation of Environmental Control Systems Used in Parenteral Facilities / Franco De Vecchi217
10Validation of Utilities / Barry D. Garfinkle261
11The Validation of Pharmaceutical Water Systems / Theodore H. Meltzer279
12Microbiology of Sterilization Processes / Timothy J. Leahy, Kerry L. Roche, Maura R. Christopher353
13F, D, and Z Values / John Shirtz381
14Validation of Steam Sterilization in Autoclaves / Phil DeSantis413
15Steam Sterilization-in-Place Technology and Validation / James P. Agalloco451
16Dry-Heat Sterilization and Depyrogenation / Laurie B. Colman, Gayle D. Heffernan483
17Validation of Gas Sterilization / David F. Bekus527
18Validation of Radiation Sterilization Processes / John F. Reger541
19Validation of Sterilizing-Grade Filters / John McGrath, Richard Levy555
20Validation of Unique Filtration Processes / Carole S. Genovesi585
21Disinfectants / James D. Wilson617
22Cleaning and Sanitization of Cleanrooms and Materials / Anne Marie Dixon645
23Validation of Aseptic Processing / James P. Agalloco, James E. Akers669
24Component Preparation Processes / Dominic A. Ventura, Stephen W. Goodsir703
25Validation of Lyophilization / Edward H. Trappler721
26Validation of Packaging Operations / Charles S. Levine751
27Retrospective Validation / James P. Agalloco791
28Regulatory Aspects of Validation / Ralph Badagliacca807
29Process Control and Quality Systems for a Changing World / James E. Akers821
 Index831



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