Course Descriptor
This programme is designed to provide an introduction to current aseptic techniques related to working in an aseptic filling environment. This blended programme provides both a theoretical introduction to contamination control, environmental monitoring, filter integrity testing and filling systems, while also allowing trainees hands-on interaction with both isolator and RABs units while conducting glove integrity tests, media fills and troubleshooting. An introduction to Grade B gowning will also be included in the programme.
Course delivery method: Blended online and onsite training
- Two mornings online theory
- Two Days NIBRT Practicals
Course Costs:
- Two mornings online theory only: €950
- Full course of Two mornings online theory and 2 days NIBRT Practicals: €2,850
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March Delivery |
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September Delivery |
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Introduction to Fill Finish Operations
€950.00 – €2,850.00
Dates:
- 11/09/2023 - 12/09/2023
4 Places Remaining
- 11/09/2023 - 19/09/2023
Out of stock
Fee:
€2850Suitable for:
- Manufacturing
- QA/QC
- Engineering Technicians
- Specialists
- Operators
Who should attend
- Manufacturing
- QA/QC
- Engineering Technicians
- Specialists
- Operators
Key topics covered
- 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
Learning outcomes
Upon completion of this course the trainee will be able to:
- Demonstrate an increased proficiency of techniques and skills relating to aseptic processing
- Evaluate environmental monitoring programmes 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
Assessment
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.
