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 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 :
I.
Introduction
II. Sterilization
III. Sterilization and
Sanitization
IV. Sterilization Validation and the Regulatory
Environment
V. Fundamentals of Microbial Death
Logarithmic Order of Death
D Value
Z Value
F Value
Probability of a Nonsterile Unit
VI. Biological Indicators
VII.
Physical Measurements
Temperature
Pressure
Gas Concentration
Relative Humidity
Calibration
Physical/Chemical Indicators and Integrators
VIII. Methods
Development and Validation Approaches
Overkill Method
Bioburden Method
Bioburden/Biological Indicator (BB/BI) Sterilization Method
IX.
Common Elements in Sterilization Validation
Equipment Qualification
Equipment Specifications
Equipment Start-up (Shakedown or Commissioning)
Installation Qualification
Operational Qualification
Cycle Development
Empty Chamber Studies
Loaded Chamber Studies
X. Routine Use/Ongoing Monitoring
XI.
Validation Maintenance/Change Control/Revalidation
XII. Sterilization
Process-Specific Guidance
XIII. Steam Sterilization
Sterilizers
Sterilization-in-Place
Bulk Sterilization
XIV. Dry-Heat Sterilization and
Depyrogenation
Dry-Heat Ovens
Tunnels
XV. Gas Sterilization
Half-Cycle Method
Minimum-Cycle Method
Half-Minimum Method
Medical Device Sterilization
Equipment/Isolator/Environment Sterilization
XVI. Radiation
Sterilization
XVII. Conclusion
XVIII. References
XIX.
Bibliography
XX. About the Author