Dublin, Aug. 05, 2024 (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 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.
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
For more information about this conference visit https://www.researchandmarkets.com/r/el9rjp
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