Hands-on Training in Aseptic Processing
The hands-on training program in Aseptic processing is offered four times a year. Course title is "The Comprehensive Industrial Course in the Preparation of Parenteral Products". This course provides a comprehensive overview of the fundamental concepts for the preparation of Parenteral products.
- Aseptic Processing
- Environmental requirements and control
- Production process and equipment
- Sterilization principles and processes
- Quality assurance and control
- Good Manufacturing Practices (GMPs)
- Testing principles and methods
- Process Validation
- Product formulation
- Cleaning and sanitization
- Inspection trends
Course Objective and Description
This 40-hour course provides a comprehensive overview of the fundamental concepts for preparation of parenteral products. Participants work in teams to prepare a small volume parenteral (SVP) product and perform relevant quality control tests and environmental evaluations. Emphasis is on sterilization processes and proper procedures and techniques employed in aseptic processing.
Course Participants will:
- Learn principles of production and quality control
- Gain personal experience in processing of small volume parenterals (SVPs)
- Develop an overall understanding of the science and technology of sterile products processing
- Explore applicable regulations
- Exchange ideas with others
With more than 24 hours of hands-on training, the lab program provides experience in planning and preparation of small volume parenteral dosage forms. Each team consisting of no more than five members, will compound and aseptically fill a protein formulation, which will then be lyophilized. The team will also perform the sterility test in an isolator, the bacterial endotoxin test, the particulate matter test, and learn about stability testing. Other experiences will include autoclave validation, environmental monitoring, filter integrity testing, and visual inspection of liquid and lyophilized vials.