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Early Bird

Pre-Filled Syringes: End-to-End Processing Training Course (ONLINE EVENT: November 6-7, 2024)

2 Days: Nov 6th 09:30 - Nov 7th 17:00 GMT+1
  • Conference
  • Management Forum
  • ID: 5893061
OFF until Oct 02nd 2024

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.

Agenda

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

Overview: Trends in PFS Drug Delivery

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

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

  • PFS Dosing Systems
  • PFS Closing Methods
  • Containment

Terminal sterilisation of pre-filled syringes - strange but feasible

  • Points to consider
  • Aseptic filling vs terminally sterilised

Overview: Trends in PFS: Machine Technology

  • Pumps ‘fit for purpose’
  • In Process Control (IPC), filling & stoppering
  • Use of Robotics

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
  • How to set up a manual VI

Day 2

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

  • Walk through a typical facility 2° packaging line
  • Trends in secondary packaging
  • PFS handling: reduction of glass-to-glass contact

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

Moving from vial to pre-filled syringe

  • Points to consider
  • Available options

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
  • Mr 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.

  • Dale Charlton
  • Mr 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.

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.