DUBLIN--(BUSINESS WIRE)--The "Pre-Filled Syringes" conference has been added to ResearchAndMarkets.com's offering.
This course has been designed to provide a comprehensive, practical and useable overview of the production of pre-filled syringes and will provide the latest information on manufacture, packaging for fill/finish through to final (post-fill) inspection.
Quality will be a key focus for the day and topics such as quality of syringe manufacture, quality of syringe components, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.
Agenda
Pre-filled syringes for biotech: improvement in the manufacturing process development PFS systems
- New PFS formats
- Safety devices
- Self-injection devices
- Leachable and extractable considerations
Syringe manufacture from components to the final product - an overview
- The initial choice - bulk or pre-sterilised components?
- Siliconisation - not beloved, but required
- Secondary packaging and more - assembly of PFS into auto-injectors
The next step: fill/finish for nested syringes, vials, and cartridges
- A unique machine for processing pre-sterilised syringes, vials and cartridges
- Integrated capping
- Maximum product yield by using special start-up and end-of-production filling processes
- State-of-the-art peristaltic pump technology together with a combi filling station
- State-of-the-art single-use filling technology including data from the performance qualification
- Mock-up study for optimised use of barrier system
- Upstream processes for bringing the different containers to the point of fill
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 of PFS
- Materials
- Dimensional requirements
- Compatibility with existing filling lines
Design verification testing of device function for PFS
- Meeting the US FDA requirements for combination products
- Meeting the essential requirements of the Medical Device Directive (MDD) in the EU
- Identifying and verifying the critical functional and performance requirements for the components and finished pre-filled syringes
State-of-the-nation address for PFS and summary
For more information about this conference visit https://www.researchandmarkets.com/research/hs6w9v/1day_course?w=4
