Dublin, Nov. 07, 2023 (GLOBE NEWSWIRE) -- The "Pre-Filled Syringes: End-to-End Processing Training Course" conference has been added to ResearchAndMarkets.com's offering.
This intensive two-day course is designed to provide a comprehensive, practical, and actionable review of the production of Pre-Filled Syringes (PFS). It will cover all aspects of the PFS manufacturing process, from production and packaging for fill/finish to final post-fill inspection.
Quality will be a central focus of the program, with extensive coverage of manufacturing process improvements, including advancements in cleanroom technology and sterilization. Other sessions will address visual inspection and the latest regulatory requirements to ensure participants are fully up to date with industry standards. The expert speakers will provide valuable guidance and advice based on their practical experience in this field, and there will be ample opportunities for discussion.
This event is suitable for a wide range of professionals, including those from pharma start-ups, small and medium-sized pharma companies, Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), machine suppliers, hospital dispensaries, and anyone new to PFS or seeking to deepen their understanding in a relaxed and open environment.
It will be particularly valuable for individuals working in PFS with responsibilities in device programs, 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 highly beneficial.
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.
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 conference visit https://www.researchandmarkets.com/r/i7axyt
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