Course overview
This course offers a comprehensive introduction to the world of pre-filled syringes (PFS), designed specifically for those who are new to the field or looking to refresh their understanding of the fundamentals. Participants will gain a clear overview of the entire processing journey, from component selection and design considerations through filling, assembly, and quality control.
What sets this program apart is the independence of its expert speakers, who provide practical, vendor-neutral insights based on real-world experience across different parts of the industry. Their diverse perspectives help ensure a balanced view of current practices and future directions, free from commercial bias.
In addition to structured presentations, delegates will benefit from interactive workshops designed to encourage discussion, questions, and peer-to-peer exchange. This creates a unique opportunity not only to learn the essentials of pre-filled syringe processing, but also to explore the latest developments and challenges shaping the field today.
CPD Hours: 12
Course Content
- Day 1
- Syringe manufacture from components to the final product - an overview
- PFS filling & closing machines - available options
- PFS filling & closing machines - a closer look
- Terminal sterilisation of pre-filled syringes
- Visual inspection of pre-filled syringes
- Secondary packaging machines for PFS: an introduction
- Trends in PFS: drug delivery
- Day 2
- PFS: from the early days to the latest developments
- Device assembling and control processes for autoinjectors
- A primer on system selection
- Regulatory requirements for pre-filled syringes
- Workshop: for 3 product profiles
- What comes back - typical technical complaints
- PFS state-of-the-union address and event summary
Speakers
Dale Charlton
Dale Charlton is a Freelance Consultant for automation and fill / finish. Dale has spent a lifelong career in Life Sciences and Biotechnology encompassing both the academic and industrial sectors. Dale worked in a technical capacity in basic R&D at a major University and EMBL Heidelberg before embarking on a more formal academic career in biotechnology and studying for a PhD within the Drug Discovery Group of Pfizer into growth factor research (rGH, GHRF, IgF) . With industrial spells at Porton Down and Pittman-Moore (formerly Glaxo Animal Vaccines) in API and API scale-up, Dale settled back into biotech manufacture and moved more into the supply chain of finished drug products for small molecules & biologics, first as the MD of a life sciences distribution company and later as Director of Business Development, Optima pharma in sterile production automation. Having worked in the pharmaceutical industry from R&D to finished drug product, Dale has a unique understanding of the entire drug development life cycle and offers insight from both the pharma and a suppliers perspective.
Andreas Rothmund
Dr. Andreas Rothmund is Qualified Person (retd) at Vetter Pharma-Fertigung in Ravensburg, Germany, an independent contract manufacturer specialised in the aseptic production of pre-filled application systems. He started his industrial career in 1985 as a lab manager. After two years he took over production responsibility for a German company specialised in eye drops and eye ointments, a position he held for nearly eight years.
He joined Vetter in 1994, where he has held several positions, including Head of Production for one of Vetter’s aseptic production units. He holds a degree in organic chemistry from the University of Constance, Germany.
Susanne Hall
Susanne Hall began her career in 1990 at Dr. Karl Thomae (today known as Böhringer Ingelheim) in Biberach as Head of Packaging Technology. In 1993, she joined Vetter’s Research and Development department as Head of Packaging Material Incoming Control and in 2008 was named Team Leader of Secondary Packaging.
Since 2019, she has been the Director of Secondary Packaging and AVI Projects. In this position, Susanne leads three teams that ensure the implementation of customer products from development to commercial into production. For secondary packaging this includes device assembly, labeling and final packaging as well as implementing tests for a controlled safe process and the meeting of customer expectations. She is also responsible for the transfer of products from manual visual inspection to fully automated inspection lines.
Susanne has a diploma in engineering from the College of Engineering where she focused on specialized precision engineering.
