PDA EU00163 All about Pre-Filled Syringe Systems - Basic Course

Malaga, Spain
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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 is mainly suited for individuals new in the PFS environment or to refresh dated knowledge. Understanding the specifics of materials like glass, special polymers and elastomers is key for a successful finished PFS drug product. The speakers give guidance into the complex interdependencies of PFS as both primary packaging and medical device.

Fill&Finish necessities will be trained in detail. Next to relevant practical aspects and trends of developing and processing of pre-filled syringes, the course 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 study pieces of equipment such as syringes, stoppers, needle shields and tip caps in detail. Processing steps, inspection and quality aspects will be demonstrated. Discussions of real case examples and Q&A sessions will complement the course.

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
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
Event Location
Higueron Hotel Malaga
Av. del Higuerón, 48, Malaga, Spain 29640 Get Directions

Contact

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
training-europe@pda.org
Registration Customer Care

Standard Registration

Member Price

€ 2.200

Non-Member

€ 2.200

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

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 registration-europe@pda.org 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, 27 March 2025

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 barrel
  • Plunger stopper
  • Staked in needled and luer connectors
  • Needle shield
  • Safety devices and autoinjector
10:45
Coffee Break

11:15
Regulatory and Phamaceutical Aspects

  • Short overview on regulatory guidelines and technical standards: EU / US / ISO / ...
  • Short overview and introduction into drug-syringe interactions

11:45
Overview and Introduction to Manufacturing Process of Pre-Fillable Syringes

  • Glass syringes and COP/COC syringes
  • Barrel forming and needle mounting
  • Washing with WFI
  • Siliconization
  • Nest and tub, bags
  • Sterilization
  • Basics of regulatory guidelines and technical standards: EU / US / ISO / …

12:45
Lunch Break

13:45
Fill and Finish

  • Bag opening
  • Tub opening
  • Filling
  • Stoppering

14:30
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, 28 March 2025

9:00
Recap Day 1

9:15
The Syringe (Body) - walk through 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
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.

Featured Trainers

  • Christa Jansen-Otten

    West

    Read Bio

  • Klaus Ullherr

    Syntegon Technology

    Read Bio

  • Bernd Zeiss

    Gerresheimer Bünde GmbH

    Read Bio

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.

Higueron Hotel Malaga

Av. del Higuerón, 48
Malaga, Spain 29640, Spain
Make a Reservation Online

PDA recommends the reservation at the following hotel

Higueron Hotel Malaga
Av. del Higuerón, 48
Malaga, 29640
Spain

PDA Europe has reserved a limited number of rooms until 28 January 2025.

Book your room now at the special PDA Group Rate via the reservation button above and enjoy exclusive benefits! Secure your discounted room rate, enjoy free parking, discounted access to the Spa, and relax with full access to the pool during your stay. Don’t miss out on these perks – reserve today!

How to Get Here
By Air From Málaga-Costa del Sol Airport (AGP): The hotel is about 20 km away. A taxi will take about 20 minutes, or you can take the C1 train from the airport to the Carvajal station, which is a 5-minute taxi ride or 15-minute walk to the hotel.
By Car The hotel is easily accessible from the AP-7 highway. Use GPS with the address Av. del Higuerón, 48. Parking is available at the hotel.
By Other Options Train: The Carvajal train station (C1 line) is the closest stop, about 2 km away. From there, you can take a short taxi ride or walk. Bus: Local buses serve the Fuengirola area, with a bus stop near the hotel.
Area Attractions
  • Fuengirola Beach (10-minute drive)
  • Bioparc Fuengirola (15-minute drive)
  • Picasso Museum, Málaga (25-minute drive)

Did you know? Málaga is one of the oldest cities in the world, founded around 770 BC by the Phoenicians, making it over 2,800 years old!