PDA All About Pre-Filled Syringe Systems - Basic Training Course
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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
Highlighted Trainers
Key Presenters
Agenda
Discover What's Happening Each Day
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
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
PDA Extractables and Leachables Training Course
27 Mar - 28 MarPromotions and Press
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Venue Details and Accommodations
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.
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
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!
Registration
Pricing Options
Standard Registration
Member Price
€2,200Non-Member
€2,200
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.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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