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2023 PDA_Training-1988x680

PDA EU00163 All about Pre-Filled Syringe Systems

Apr 25 - Apr 26, 2024
Copenhagen, Denmark

  • Education
  • Europe
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Program Highlights

Overview

Join us on a journey, from the components of a syringe to the customer needs of a pre-filled syringe system.

This two-day interactive course will provide an overview of relevant practical aspects and trends of developing and processing of pre-filled syringes. It will also address basics in regulatory requirements related to materials, components and processes of pre-filled syringes.Special focus is given to the performance and pharmaceutical requirements, user requirements will be touched.

In hands-on sessions, participants will have the opportunity to study pieces of equipment such as syringes, stoppers, needle shields and tip caps in more detail. Processing steps, inspection and quality aspects will be demonstrated using state-of-the-art technology. Discussions of real case examples and Q&A sessions will complement the course.

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Agenda

  • Day 1
  • Day 2

  • Thursday, 25 April 2024

    9:00
    Welcome & Introduction

    9:15
    Overview and Introduction into Pre-filled Syringe Market

    • Overview & Trends
    • Stakeholders
    • User’s perspective

    10:15
    Technical Aspects

    • Syringe
    • Stopper
    • Plunger
    • Needle
    • Needle shield
    • Safety devices
    • Autoinjector
    • Basics of regulatory guidelines and technical standards: EU / US / ISO / …
    10:45
    Coffee Break

    11:15
    Technical Aspects (cont.)

    11:45
    Overview and Introduction Into Drug-Syringe Interactions

    • Aggregation
    • Degeneration
    • Oxidation
    • Viscosity
    • Bubbles

     

    12:15
    Overview and Introduction to Manufacturing Process of Pre-Filled Syringes

    • Barrel forming
    • Washing
    • Siliconization
    • Sterilization
    • Basics of regulatory guidelines and technical standards: EU / US / ISO / …

    13:00
    Lunch Break

    14:00
    Fill and Finish

    • Bag opening
    • Tub opening
    • Filling
    • Stoppering

    14:45
    Hands-on Session 1

    15:30
    Coffee Break

    16:00
    Hands-on Session 1 (cont.)

    16:45
    Q & A

    17:00
    End of Training Course Day 1

  • Friday, 26 April 2024

    9:00
    Recap Day 1

    9:15
    The Syringe (Body) - Example Specification

    • Materials (glass, polymer)
    • Shape
    • Cone
    • Diameter
    • Mechanical properties
    • Chemical Properties
    • Siliconization
    • Impact of different drug properties
    • Needle shield, tip cap
    • Nest, tub
    • Integrated needles, luer lock adapter, cone types
    • Back stops, rods
    • Basics of regulatory guidelines and technical standards: EU / US / ISO / …
    10:15
    Coffee Break

    10:45
    Plunger Stopper, Needle Shields, Tip Caps

    • Materials
    • Physical properties
    • Chemical properties
    • Washing
    • Siliconization
    • Impact of different drug properties
    • Syringe system functionality
    • Basics of regulatory guidelines and technical standards: EU / US / ISO / …

    11:45
    Manufacturing Aspects Regarding Filling, Finishing and Assembly

    • Rod insertion and labelling
    • Combi filling
    • Robot filling
    • New trends

    12:30
    Lunch Break

    13:30
    Hands-on Session 2

    14:30
    Q & A

    15:00
    End of Training Course

Trainers

Christa Jansen-Otten
Christa Jansen-Otten
West
Bio
Christa Jansen-Otten
West
Since 2016 Christa holds her position as Director of Global Product Management, Prefilled Systems and Delivery, at West Pharmaceutical Services, Inc. She has worked within the pharmaceutical industry for more than 20 years. Christa gained experience as Quality Assurance Manager in one of the world’s leading pharmaceutical companies for sterile filling and packaging. In addition, she spent several years with the leading pre-fillable syringe manufacturer in the Customer Quality Assurance department. She joined West in 2005 and developed an expertise in pre-filable systems and delivery technology in the Technical Customer Service and Marketing departments. Christa holds a diploma in Biomedical Engineering from the University of Aachen.
Klaus Ullherr
Klaus Ullherr
Syntegon Technology
Bio
Klaus Ullherr
Syntegon Technology

Klaus Ullherr (Senior Product Manager) has a degree in electrical engineering. After university, he worked for several years as a project manager in the electrical industry.

In March 2000, he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid (now Syntegon Technology). During the first two years, he was responsible for handling complex customer orders. Since 2002, he is product manager for the business fields syringes and RTU (ready-to-use) containers with global product responsibility.

His main functions are Market Analysis, Initiating New Product Developments, Business development and expert for syringe/nested container processing.He is member of the PDA and works as an expert in the DIN/ISO group for primary packaging. Klaus is also member of ISPE and member of the program committee of the yearly ISPE Aseptic Conference.

He is a well-known speaker and trainer covering trends and solutions for fill/finish equipment especially for pre-filled syringes and other pre-sterilized containers.
Bernd Zeiss
Bernd Zeiss
Gerresheimer Bünde GmbH
Bio
Bernd Zeiss
Gerresheimer Bünde GmbH

Bernd Zeiss is biologist by education and graduated from the University of Göttingen, Germany. After several years working as a biostatistician, in lab automation and in pharma sales, he is a member of the Gerresheimer business development team since 2011. He works in the Gerresheimer Centre of Excellence for prefillable systems as Head of Global Pharmaceutical Support. His main areas of work are technical customer support with regard to prefillable syringe systems and vials, and he is leading the strategic sample stock for primary packaging. Together with pharma customers he is also investigating the interactions of drug container components regarding drug substances.

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the course participants will:
    • Know the stakeholders in pre-fillable and pre-filled syringes
    • Understand what the packaging supplier can support with and what can only be done at the pharma company
    • Understand pre-filled syringe technologies, materials, applications and requirements
    • Are able to develop a syringe system that fits the needs of a dedicated application
    • Are able to compare different syringe types with regard to their advantages and disadvantages
  • Who Should Attend
    • Packaging engineers with little or no experience in pre-filled syringes
    • Pharmacists and formulation developers who want to learn about pre-filled syringes as a device
    • Quality, Purchasing, Business Development, Sales
    • Future regulatory expertsshould attend dedicated training courses
    • Device engineers with focus on Autoinjectors are asked to join dedicated training courses

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Ellehammersvej 20
Copenhagen, Denmark

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Registration Fees

Regular Price
Registration Type Price
All Participants €2.090

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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