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Parenteral Drug Association Connecting People, Science and Regulation ®

Test Methods for Pre-filled Syringe Systems -Fall Edition

Oct 24 - Oct 25, 2019 |
Oct 25, 2019 |
The Swedish Exhibition & Congress Centre Gothia Towers Hotel | Gothenburg, Sweden
  • Education
  • Europe
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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.

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

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


Horst Koller, CEO, HK Packaging Consulting
Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience. His consulting company is focusing on Technical, Regulatory and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international conferences. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.

Thursday, 24 October 2019


Introduction to Syringe Systems and Components

Coffee Break

Regulatory Requirements of Finished Pre-filled Syringes – Part 1

  • System Characterization / Physical Characterization

Lunch Break

Regulatory Requirements of Finished Pre-filled Syringes – Part 2

  • Pharmaceutical Characterization

Coffee Break

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

Wrap-up of Day 1

End of Day 1

Friday, 25 October 2019

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

  • Cone Breakage / Flange Breakage / Leakage

Coffee Break

Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 1 (cont.)

  • Cone Breakage / Flange Breakage / Closure Testing

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

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

Lunch Break

Additional Testing for Use in Delivery Devices

Wrap-up of Day 2

End of Training Course

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

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All fees given in Euro and excluding VAT (25%)

All Participants

1595 Euro


Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

The Swedish Exhibition & Congress Centre Gothia Towers Hotel
Mässans Gata 24
41294 Gothenburg, Sweden

Hotel Accommodation

optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2019. We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting an official PDA Europe hotel.

You can book your Hotel Accomodation here!

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66

Register Now