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2021 UPS_1988x680

PDA EU00163 All About Pre-Filled Syringe Systems

Oct 07 - Oct 08, 2021
Gothenburg, Sweden

  • Education
  • Europe

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Overview

Join us on our journey from the components of a syringe to a customer needs oriented 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 relevant regulatory requirements related to materials, components and processes of pre-filled syringes. Special focus is given to the perspectives of health care practitioners and patients covering the relationships of syringe properties with aspects of drug administration. 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.

Agenda

  • Day 1
  • Day 2
  • Thursday, 07 October 2021

    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
    • 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
    • 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 Day 1

  • Friday, 08 October 2021

    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
    • 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
    • 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 Course

Trainers

Christa Jansen-Otten
Christa Jansen-Otten
West
Klaus Ullherr
Klaus Ullherr
Syntegon Technology (former Bosch Packaging Technology)
Bernd Zeiss
Bernd Zeiss
Gerresheimer Bünde GmbH

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the course participants
    • 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

    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
     

Got a Question? We have answers

Contact Us

Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

The Swedish Exhibition & Congress Centre Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden

The Swedish Exhibition & Congress Centre Gothia Towers Hotel

How to Get Here

By Air

Nearest Airport: Gothenburg-Landvetter Airport – GOT
Airport Phone:
+46 10 109 31 00

By Car

22.9 km, 20 min by car. Gothia Towers is located at Mässans gata 24, Göteborg.

E6/E20 (from the north) and road 45 (from Karlstad): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the first exit on the left, then turn right on to Örgrytevägen and then take the next right exit for the hotel.

E6/E20 (from the south) and road 40 (from Borås): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the second exit on the right for the hotel.

Other Options

Flygbussarna airport coach: to Korsvägen/the Swedish Exhibition & Congress Centre, opposite the hotel.

Public transportation: Korsvägen stop, 100 meters from hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

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

* 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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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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