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2020 Medical Device

PDA Europe Virtual Training Course - Test Methods for Pre-filled Syringe Systems

Sep 10 - Sep 11, 2020
9:00 AM
6:00 PM
| W. Europe Standard Time
  • Virtual
  • Education
  • Online
  • Europe


The course will be an interactive lecture around Pre-filled Syringe Systems including ISO compliance testing. The participants will benefit from first hand information of both lecture leaders based on practical experience. The lecture includes the life cycle of a PFS from the idea to the finished marketed product.


  • Day 1
  • Day 2
  • Thursday, 10 September 2020


    Introduction to Syringe Systems and Components

    Regulatory Requirements of Finished Pre-filled Syringes – Part 1

    • System Characterization / Physical Characterization

    Regulatory Requirements of Finished Pre-filled Syringes – Part 2

    • Pharmaceutical Characterization

    Luer cone and Luer lock Compliance Testing for Glass and Polymer Syringes

    Wrap-up of Day 1

    End of Day 1
  • Friday, 11 September 2020

    Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 1

    • Cone Breakage / Flange Breakage / Leakage

    Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 2

    • Break Loose and Gliding Force / Needle Testing / Particulate Matter

    Additional Testing for Use in Delivery Devices


    Wrap-up of Day 2

    End of Training Course


Horst Koller
Horst Koller
HK Packaging Consulting GmbH

Learning Objectives

Upon completion of the course the participants will have solid knowledge of

  • Materials used for PFS Systems
  • Luer Cone and Luer Lock Compliance Testing
  • Requirements for the empty sterile sub-assembled syringe ready for filling
  • Test Methods for Drug Product Filled Syringes
  • PFS used in Delivery Systems

Who Should Attend

The course is designed specifically for those who are involved or interested in the development, manufacturing and QC-testing of a Pre-filled Syringe System:

  • Engineers and Managers in Device Development and all other technical functions surrounding syringe systems
  • Manufacturing Supervisors
  • Quality Personal / Regulatory Personal
  • Clinical and commercial Drug Product Manufacturing

Registration Fees

Register Now
Registration Type Price
All Participants €400

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