Validation of Sterilization Processes (single user digital version)

Sep 2004
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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

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

  • 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
  • About the Authors