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 :
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