Designing a Contamination Control Program (single user digital version)

Sep 2004
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PDF Single user
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This booklet includes 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.

Designing a Contamination Control Program

This booklet focuses on the various aspects of sterile product manufacturing that must rely on classical aseptic processing methodologies for bulk processing or aseptic filling or both. It describe the design and implementation of a comprehensive contamination control program for aseptic processing.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 8.83 MB)

Table of Contents

Table of Contents :

I. Introduction

  • Sterile Drug Products

    II. The Elements of an Aseptic Process
  • Operator Training and Aseptic Qualification
  • Chemical Disinfection
  • Sterilization of Containers and Closures, Materials, Equipment, and Drug Product
  • Controlled Environments
  • Aseptic Gowning
  • Barriers
  • Defined SOPs
  • Quality Operating Systems

    III. Contamination Control
  • Sources of Contamination
  • Proper Clean Room Behavior
  • Working in Laminar Flow

    IV. Process Simulation Studies (Media Fills)
  • Introduction
  • Sterile Bulk Process Simulations
  • Principles of Challenge: Aseptic Filling and/or Bulk Processing

    V. Additional Measurements
  • Environmental Monitoring
  • Sterility Testing
  • Bioburden
  • Data Trending and Analysis
  • Correlation of Assessments/Annual Product Reviews

    VI. Conclusion
    VII. References
    VIII. Additional Reading
    IX. About the Author