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PDA EU00163 All about Pre-Filled Syringe Systems - Basic Course
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Individual Registration
Group Registration
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
Contact
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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.
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
Featured Trainers
-
Christa Jansen-Otten
West
Read BioChrista Jansen-Otten
West
Since 2016 Christa holds her position as Director of Global Product Management, Prefilled Systems and Delivery, at West Pharmaceutical Services, Inc. She has worked within the pharmaceutical industry for more than 20 years. Christa gained experience as Quality Assurance Manager in one of the world’s leading pharmaceutical companies for sterile filling and packaging. In addition, she spent several years with the leading pre-fillable syringe manufacturer in the Customer Quality Assurance department. She joined West in 2005 and developed an expertise in pre-filable systems and delivery technology in the Technical Customer Service and Marketing departments. Christa holds a diploma in Biomedical Engineering from the University of Aachen. -
Klaus Ullherr
Syntegon Technology
Read BioKlaus Ullherr
Syntegon Technology
Klaus Ullherr (Senior Product Manager) has a degree in electrical engineering. After university, he worked for several years as a project manager in the electrical industry.
In March 2000, he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid (now Syntegon Technology). During the first two years, he was responsible for handling complex customer orders. Since 2002, he is product manager for the business fields syringes and RTU (ready-to-use) containers with global product responsibility.
His main functions are Market Analysis, Initiating New Product Developments, Business development and expert for syringe/nested container processing.He is member of the PDA and works as an expert in the DIN/ISO group for primary packaging. Klaus is also member of ISPE and member of the program committee of the yearly ISPE Aseptic Conference.
He is a well-known speaker and trainer covering trends and solutions for fill/finish equipment especially for pre-filled syringes and other pre-sterilized containers.
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Bernd Zeiss
Gerresheimer Bünde GmbH
Read BioBernd Zeiss
Gerresheimer Bünde GmbH
Bernd Zeiss is biologist by education and graduated from the University of Göttingen, Germany. After several years working as a biostatistician, in lab automation and in pharma sales, he is a member of the Gerresheimer business development team since 2011. He works in the Gerresheimer Centre of Excellence for prefillable systems as Head of Global Pharmaceutical Support. His main areas of work are technical customer support with regard to prefillable syringe systems and vials, and he is leading the strategic sample stock for primary packaging. Together with pharma customers he is also investigating the interactions of drug container components regarding drug substances.
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