Pre-Filled Syringes: End-to-End Processing (2-Day Virtual Training Course: July 25-26, 2024)
Dublin, May 24, 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.
*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
For more information about this conference visit https://www.researchandmarkets.com/r/qwea7n
*About ResearchAndMarkets.com*
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
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