Disinfection, Sterilization, and Containment

This course introduces principles of contamination and containment for the biopharmaceutical industry along with responses using various procedures and engineering controls.

Additional procedures discussed include special gowning requirements and restricted personnel movement. Engineering controls presented include implementing air showers for exit procedures and use of isolators. Facility design considerations are also discussed.

Audience

Manufacturing Technicians
Team Leaders and Supervisors
Quality Control Personnel
Quality Assurance Personnel
Maintenance / Engineers

Topics Include

Contamination: Physical, Chemical, and Microbiological
Basic Microbiology
Detergents, Sanitants and Sterilants
Effective Cleaning: Equipment and Facilities
Sterilization Methods: Moist Heat, Dry Heat, Gamma Irradiation, Ethylene Oxide
Containment: Concepts, Strategies, Equipment, and Considerations
Biosafety

Learning Objectives

Define facility and product contamination
Discuss effects of contamination on industry practices with regard to consumer safety
Recognize basic microbiological concepts
Explain sterilization processes including:
- Steam sterilization
- Dry-heat sterilization
- UV light
- Chemical applications
Appreciate the complexities of potent drug manufacturing or process contamination containment strategies