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.
Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.
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.
Programme day one
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 filling overview
PFS over time
- Evolution of components
- Evolution of processes and equipment
- Evolution of application and application systems
PFS for biotech: improvement in the manufacturing processes
- Controlled tungsten
- Optimised silicone oil
- Tighter controlled dimensions
- Fit-for-device function
Trends with PFS
- New PFS formats
- Safety devices
- Self-injection devices
- Leachable and extractable considerations
Filling and closing: multi-format machine for nested syringes, vials, and cartridges
- Dosing and filling systems in comparison
- Closing methods and their applications
- Format parts - easy to change
Secondary packaging of PFS/vials/ cartridges
- Materials/dimensional requirements
- Compatibility with existing filling lines
- Handling of ready-to-fill vials and cartridges
Advances in cleanroom technology
- PFS component choice
- PFS filling and closing
- Cleanroom technology
Programme day two
Terminal sterilisation of pre-filled syringes - strange but feasible
- Points to consider
- Aseptic filling vs terminally sterilised
Visual inspection of pre-filled syringes
- Why do we inspect? Regulatory requirements
- 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
Regulatory requirements for pre-filled syringes
- ISO design compliance
- Pharmacopoeia compliance
- New MDR - what about it?
- Responsibilities in contracted operations
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
- Terminal sterilisation vs aseptic filling
- Secondary packaging
- Case study
Open floor: all topics and related topics, including:
- Good distribution practice (GDP)
- Drug delivery devices: auto-injectors, pen injectors, wearable devices
PFS state-of-the-union address and event summary
- Review of market drivers and drug development
- Future trends in PFS
Final discussion session and concluding remarks
For more information about this conference visit https://www.researchandmarkets.com/r/vcf3ky