Dublin, Jan. 28, 2020 (GLOBE NEWSWIRE) -- The "Pre-Filled Syringes: End-to-End Processing" 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.

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.

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.

Agenda

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
• Containment

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

• Isolator
• RABS
• V-CRT

Panel discussion

• 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
• 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

Regulatory requirements for pre-filled syringes

• ISO design compliance
• Pharmacopoeia compliance
• New MDR - what about it?
• Responsibilities in contracted operations

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

Panel discussion

• 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/gdzeon

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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