PDA EU00163 All about Pre-Filled Syringe Systems

Gothenburg, Sweden
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Program Highlights
Note In response to considerable demand, all participants will now be given access to electronic course notes, which may be printed once for use during the course approximately 1-2 weeks in advance. Hard copies of course notes will be no longer  provided to participants.

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.

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

Standard Registration

Member Price

€1.895

GovernmentMember Only

€1.895

Health AuthorityMember Only

€1.895

Early Career ProfessionalMember Only

€1.895

StudentMember Only

€1.895

AcademicMember Only

€1.895

Non-Member

€1.895

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

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, 19 October 2023

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

Day 2

Friday, 20 October 2023

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

Agenda is subject to change.

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 , Sweden

PDA recommends the reservation at the following hotel

Gothia Towers Hotel
Mässans Gata 24
41294 Gothenburg,
Sweden

PDA Europe has reserved a limited number of rooms until the 15th August 2023.

Book your room at the PDA Group Rate via the above-mentioned reservation button.


Just a 20-minute walk from the hotel you will find The Garden Society of Gothenburg - one of Europe's best-preserved 19th-century parks. At the other end of town you will find the Botanical Garden, a world-class botanical garden with over 16,000 species to admire.

How to Get Here
By Air Airport buses travel to and from Landvetter Airport (appox. 20 min. journey) stopping at Korsvägen/Svenska Mässan. They run directly between these stops.
By Car E6 / E20 (from north) and road 45 (from Karlstad): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Take the first exit on the left, turn right onto Örgrytevägen and then take the next exit right towards Svenska Mässan. E6 / E20 (from south) and road 40 (from Borås): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Then take the second exit right towards the hotel.