Introduction to Fill-finish provides an introductory overview to current aseptic techniques related to working in an aseptic filling environment. This program provides both an introduction to contamination control, environmental monitoring, filter integrity testing and filling systems, and hands-on interaction with RABs units while conducting glove integrity tests, media fills and troubleshooting.

Who should take this course?
This course is designed for those who will work or work in Fill-Finish, and those looking to learn and enhance their knowledge about operations in a modern biomanufacturing plant. The hands-on training will demonstrate the filling process and discuss engineering or quality aspects that are relevant to operators, engineers, or quality specialists.

Topics

• Aseptic definition, scope and process simulations (media fills)
• Good aseptic technique
• Basic microbiology, environmental monitoring, and control systems
• 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 barrier technology
• Environmental data trending and excursion analysis
• Manual visual inspection
• Facility design, velocity and airflow studies

Learning Objectives
Upon successful completion of this module, trainees will be able to:

• Demonstrate an increased proficiency of techniques and skills relating to aspect processing in filling activities
• Evaluate environmental monitoring programs to collect appropriate data, identify and interpret trends
• Describe the importance of filter integrity testing when filtering water, gasses 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

Assesment
A competency-based assessment will be undertaken at the end of the training course. This will certify proficiency pertaining to both theoretical knowledge and practical skills. 

Delivery

• In English
• Onsite at the CASTL Biomanufacturing Training Facility - Charlottetown, PE