INTRODUCTION TO FILL AND FINISH
COURSE DESCRIPTION
Introduction to Fill and 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.
Current Offerings:
April 12-13, 2023
June 14-15, 2023
August 23-24, 2023
October 11-12, 2023
AUDIENCE
This course is designed for those who will work or work in Fill & Finish, 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 is relevant to operators, engineers, or quality specialists.
TOPICS
- Facility design, velocity and airflow studies
- 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
LEARNING OBJECTIVES
On completion of this module, attendees should be able to:
- Demonstrate an increased proficiency of techniques and skills relating to aseptic 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, 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
COURSE DELIVERY MODEL
Introduction to Fill and Finish
$3,695.00 +HST