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

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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