PDA EU00168 Test Methods for Pre-Filled Syringe Systems

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Program Highlights

The course is an interactive presentation on prefilled syringes, including ISO compliance testing. Participants will benefit from first-hand information from the presenter based on practical experience. The lecture covers the life cycle of a PFS from idea to final marketed product.

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

Standard Registration

Member Price


GovernmentMember Only


Health AuthorityMember Only


Early Career ProfessionalMember Only


StudentMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.


WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Thursday, 7 October 2021


Session 1: Syringe Systems and Materials

  • Glass / Plastic Materials
  • Glass / Plastic Syringe Manufacturing Processes
  • Advantages & Disadvantage of Syringe Materials

Session 2: Luer Compliance Requirements

  • ISO 80369-7 Dimensional Requirements
  • ISO 803697 – 20 Testing Requirements
  • Relation to ISO 11040-4 /-6 (Glass / Plastic Syringes)

Q&A Session

End of Day 1

Day 2

Friday, 8 October 2021

Welcome Day 2

Session 3: Empty Pre‐assembled PFS

  • ISO 11040-4 / -6 Testing Requirements
  • Test Method Descriptions / Explanations

Session 4: Final Filled PFS

  • ISO 11040-8 Testing Requirements
  • Device Implementation

Q&A Session

End of Course
Agenda is subject to change.

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