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

Copenhagen, Denmark
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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

Standard Pricing

Standard Member Price

€ 2.090

Non-Member

€ 2.090

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, 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 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, 26 April 2024

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

Featured Trainers

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.

Clarion Hotel Copenhagen Airport

Ellehammersvej 20
Copenhagen, Denmark , Denmark

PDA Europe recommends two hotels where you can reserve bedrooms at a reduced rate for that event.

To secure your room, please use the following booking code “PDA Europe”.

Clarion Hotel Copenhagen Airport
Ellehammersvej 20
2770 Kastrup , Denmark

Metro
Take line M2 from central Copenhagen to Copenhagen Airport (approx. 10-15 mins). Then walk through the passageway straight into the hotel lobby.

From the airport
Walk through the passageway from Terminal 3 and straight into the hotel lobby (approx. 2 mins).

Comfort Hotel Copenhagen Airport - The Hangar
Ellehammersvej 18
2770 Kastrup , Denmark

Metro
Take line M2 from central Copenhagen to Copenhagen Airport.

From the airport
The hotel is just a 5-minute walk from Terminal 3.

How to Get Here
By Air Unlock discounted pricing with the following code DEAPILO and simply use the provided link below.
By Other Options By Train: Unlock discounted pricing and simply use the provided link below.