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PDA EU00168 Test Methods for Pre-Filled Syringe Systems

Oct 07 - Oct 08, 2021
2:00 PM
-
4:30 PM
| W. Europe Standard Time
Online
  • Virtual
  • Education
  • Online
  • Europe
Register Now

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, 7 October 2021

    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

    16:30
    End of Day 1

  • Friday, 8 October 2021

    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

    16:30
    End of Course

Trainers

Horst Koller
Horst Koller
HK Packaging Consulting GmbH
Bio
Horst Koller
HK Packaging Consulting GmbH

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 focussing 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.

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 €500

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