- Basic Requirements of Manufacturing of Sterile Medicinal Products
- Pre-requisites for sterile Manufacturing
- Process of Microbial Destruction
- Sterilization Process Design versus Over Kill Approach
- Sterility Assurance Level
Methods of sterilization:
- Moist Heat Sterilization
General Consideration
Qualification and Calibration
Heat Distribution Study
Heat Penetration Study
- Dray Heat Sterilization
General Consideration
Key Process Features
Tunnel Sterilizer Validation
Endotoxin Challenges in the Validation Process
- Sterilization by Filtration
Introduction to Filtration Process
Filter Qualification
Retention Efficiency
Aseptic Processing
Other Integrated Systems Requiring Qualification & Validation
Facility design & Construction
Heating Ventilation & Air Conditioning System HVAC System
Water System
Compressed Gas System
Filling and Lyophilization Processes
Environmental Qualification, Validation and Monitoring
Aseptic Process Validation
- Ethylene Oxide Gas Sterilization
General Consideration
Process qualification and Validation
- Vapor Phase Hydrogen Peroxide
General Consideration
Process qualification and Validation
- Radiation
Gama, Beta, Ultraviolet
General Consideration
Process qualification and Validation
- Case Studies and Technical Writing
- Course Evaluation
12(hours)