Validation of Sterilization Processes (single user digital version)
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- PDF Single user
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- $75.00
- Nonmember Price
- $89.00
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This booklet covers the below chapter that is taken from PDA's bestselling Microbiology in Pharmaceutical Manufacturing, 1st Edition,
and provides practical advice for anyone interested in current aspects of microbiology in pharmaceutical manufacturing.
Validation of Sterilization Processes
The goal of this booklet is to describe approaches and methods that can be used to validate sterilization procedures. It will approach the subject in a manner that emphasizes the commonality of methods and practices used in the validation of different sterilization methods.
Winner, 2004 PDA/DHI Technical Book Distinguished Editor/Author Award
Validation of Sterilization Processes
The goal of this booklet is to describe approaches and methods that can be used to validate sterilization procedures. It will approach the subject in a manner that emphasizes the commonality of methods and practices used in the validation of different sterilization methods.
Winner, 2004 PDA/DHI Technical Book Distinguished Editor/Author Award
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 5.81 MB)
Table of Contents
Table of Contents :
I.
Introduction
II. Sterilization
III. Sterilization and
Sanitization
IV. Sterilization Validation and the Regulatory
Environment
V. Fundamentals of Microbial Death
VI. Biological Indicators
VII. Physical Measurements
VIII. Methods Development and Validation Approaches
IX. Common Elements in Sterilization Validation
X. Routine Use/Ongoing Monitoring
XI. Validation Maintenance/Change Control/Revalidation
XII. Sterilization Process-Specific Guidance
XIII. Steam Sterilization
XIV. Dry-Heat Sterilization and Depyrogenation
XV. Gas Sterilization
XVI. Radiation Sterilization
XVII. Conclusion
XVIII. References
XIX. Bibliography
XX. About the Author
About the Authors