Introduction to Fill-Finish

Level

Introductory

Format

On-site, practical, including essential theory

Duration

2 days

Cost

$1,881

Overview

This course offers a comprehensive introduction to aseptic techniques used in modern filling environments. Participants learn the principles of contamination control, environmental monitoring, filter integrity testing, and filling system operation. The program also includes hands-on interaction with RABS or isolator units, providing practical experience in performing glove integrity tests, conducting media fills, and troubleshooting common issues encountered in aseptic processing.

Why It’s Essential

• Builds foundational understanding of aseptic filling practices critical to sterile drug manufacturing

• Strengthens knowledge of contamination control and environmental monitoring, helping maintain product sterility and patient safety

• Teaches key filter integrity and filling system operation skills, supporting compliant and reliable production

• Provides hands-on experience with RABs/isolators, including glove integrity testing and media fills, to develop practical competency

Learning Objectives

• 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

Who Should Attend

• This course is intended for individuals working in, or preparing to enter, fill-finish operations who want to deepen their understanding of modern biomanufacturing practices. Through hands-on training, participants observe key stages of the filling process and explore the engineering and quality considerations essential for operators, engineers, and quality professionals alike.

Participants who successfully complete a theoretical assessment will receive a certificate of completion.