Key Topics Covered:
Who Should Attend?
This is a comprehensive, practical and hands-on course based on current aseptic techniques related to working in a clean room and isolator environment. The course includes microbiological monitoring, sampling, testing, validation, identiﬁcation methods and techniques.
- Deﬁnition and scope of aseptic processing
- Facility design, velocity and airﬂow studies
- Aseptic process simulations (media ﬁlls)
- Gowning and personnel qualiﬁcation and good aseptic technique
- Basic microbiology, environmental monitoring and control systems
- Sanitisation techniques and sterilisation qualiﬁcation
- Filtration and liquid ﬁlter integrity testing
- Glove integrity testing.
- Reading and evaluating media ﬁlls
- Good documentation practices
- Sterility testing and ﬁnal product testing
- Use of isolator and barrier technology.
- Environmental data trending and excursion analysis
- Formulation development
- Process Development
- Analytical Development
- Quality control
- Process and analytical validation
- Manager, supervisors and Trainers involved in Freeze Drying
- Demonstrate an increased proﬁciency of techniques and skills relating to aseptic processing
- Evaluate and improve current aseptic processing procedures at your facility
- Evaluate your environmental monitoring program to collect appropriate data, identify and interpret trends
- Incorporate proper gowning principles
- Describe the importance of ﬁlter integrity testing when ﬁltering water, gases or proteinaceous solutions
- Develop robust media ﬁll protocols including appropriate interventions, observation and documentation procedures
- Discuss ﬁnished product testing requirements
- Correlate basic microbiology concepts and techniques to multiple aspects of aseptic processing
- Integrate industry-approved sanitisation techniques and disinfectant evaluation into a comprehensive contamination control program
- Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing
A competency based assessment will be undertaken at the end of the course. This will certify proﬁciency in both the theory and in the practical skills.