Pre-Filled Syringes End-to-End Processing Training Course: Manufacturing, Fill/Finish, Inspection, Cleanroom Advances and Regulatory Updates (Nov 5th - Nov 6th, 2025) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Pre-Filled Syringes: End-to-End Processing Training Course (Nov 5th - Nov 6th, 2025)" training has been added to ResearchAndMarkets.com's offering.

This intensive two-day course has been designed to offer a comprehensive, practical, and usable review of the production of PFS and will provide the latest information on all aspects of the process from manufacture and packaging for fill/finish through to final (post-fill) inspection

Quality will be a key focus of the programme and there will be extensive coverage of improvements in the manufacturing process, including advances in cleanroom technology and sterilisation. Other sessions will address visual inspection and the latest regulatory requirements to ensure that you are fully up to date. The faculty of speakers will provide key guidance and advice from their practical experience in this field and there will be ample opportunity for discussion.

Who Should Attend:

This event is ideal for pharma start-ups, small and medium-sized pharma companies, CROs, CMOs, machine suppliers, hospital dispensaries, and anyone new to PFS or wanting to learn more in a relaxed and open environment. It will be of value to those working in the area of PFS with responsibility for device programmes, product development, product life cycle management, regulatory affairs, quality assurance and combination products. Drug delivery specialists, business development managers and product development managers will also find this course beneficial.

Benefits of attending

• Explore recent improvements in the manufacturing process
• Understand visual inspection
• Know the latest regulatory requirements

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

Key Topics Covered:

Day 1

Syringe manufacture from components to the final product - an overview

• The initial choice - bulk or pre-sterilised components?
• Siliconisation - not beloved, but required
• Handling and process overview

PFS over time

• Evolution of systems
• Evolution of components
• Evolution of application and application systems

Summing-up: Trends in PFS: Drug Delivery

• New PFS formats
• Safety devices
• Self-injection devices

Advances in cleanroom technology

• History
• RABS
• Isolator
• V-CRT - Vetter Clean-Room Technology

Filling and closing: multi-format machine for nested syringes, vials and cartridges

• Dosing and filling systems in comparison
• Closing methods and their applications
• Containment

Terminal sterilisation of pre-filled syringes - strange but feasible

• Points to consider
• Aseptic filling vs terminally sterilised

Summing-up: Trends in PFS: Machine Technology

• Pumps 'fit for purpose'
• In Process Control (IPC), filling & stoppering
• Robotics

Day 2

Visual inspection of pre-filled syringes

• Why do we inspect? Regulatory requirements
• Inspection basics
  • Defects - classification and defect evaluation lists
  • Pros and cons of different inspection methods
• Automated visual inspection of syringes - scope and limitations
• Current developments

Secondary packaging machines for PFS: hero or villain of the PFS world?

• Walk through a typical facility
• Trends in secondary packaging: labelling, safety devices
• Single machines vs combined machines

Autoinjectors

• Target Product Process
• Impact Primary packaging material
• Assembling steps
• Inline Controls
• Function / Release Tests
• Final Packaging

Regulatory requirements for pre-filled syringes

• ISO design compliance
• New MDR - what about it?
• US requirements for combination products

Case study/workshop

• Based on the key user requirements provided, participants will come up with outputs for:
• Design features of the PFS
• Test methods
• Manufacturing processes and manufacturing environment

Shipping PFSs all over the world

• Points to consider
• Shipping validation
• GDP - Good Distribution Practices

PFS state-of-the-union address and event summary

• Review of market drivers & drug development
• Future trends in PFS

Speakers:

Andreas Rothmund

Qualified Person

Vetter Pharma-Fertigung

Dr. Andreas Rothmund is Qualified Person 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

Vetter Pharma

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 adiploma in engineering from the College of Engineering where she focused on specialized precision engineering.

Dale Charlton

Director of Business Development

Optima Group pharma

Dale has spent a life long career in Life Sciences & Biotechnology spanning over 28 years covering work in both the academic and industrial sectors. Following his first degree in Biological Sciences and spells at Porton Down & Pittman Moore vaccines (Formerly Glaxo Animal Health) developing vaccines/adjuvant systems, Dale settled back into the biotech industry proper developing therapeutic Monoclonal Antibodies at Celltech in Slough UK.

Dale successfully undertook a PhD at Pfizer Drug Discovery Sandwich, Kent UK & the University of Nottingham on peptide drug candidates before moving out of academia and into the supply industry in the field of robotics and automation for the biopharmaceutical industry. Dale progressed from Product Specialist to Managing Director of an independent Life Science company until moving to his role as Director of Business Development for the Optima Group pharma, Germany and more recently to ATS Sortimat.

He has a number of scientific publications to his name and has written a number of articles for journals and magazines and regularly gives presentations at numerous international conferences in the field of Fill/Finish.

For more information about this training visit https://www.researchandmarkets.com/r/umtcvo

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