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2020 Medical Device

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

Sep 10 - Sep 11, 2020
2:00 PM
-
4:00 PM
| Central Europe Standard Time
Online
  • Virtual
  • Education
  • Online
  • Europe

Overview

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.

Agenda

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

    14:00
    Introduction


    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


    16:00
    End of Day 1
  • Friday, 11 September 2020

    14:00
    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


    16:00
    End of Course

Trainers

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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