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2020 Medical Device

All about Pre-filled Syringe Systems - From Initial Development to Final Fill Finish

Sep 10 - Sep 11, 2020
Madrid, Spain

  • Education
  • Europe

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Overview

Join us on our journey from the components of a syringe to a customer needs oriented 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 relevant regulatory requirements related to materials, components and processes of pre-filled syringes. Special focus is given to the perspectives of health care practitioners and patients covering the relationships of syringe properties with aspects of drug administration. 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 with complement the course.

Agenda

  • Day 1
  • Day 2
  • Thursday, 10 September 2020

    9:00
    Welcome


    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
    • Autoinjector
    • Regulatory guidelines and technical standards: EU / US / ISO / …

    11:15
    Coffee Break

    11:45
    Overview and Introduction into Drug-syringe Interactions

    • Aggregation
    • Degeneration
    • Oxidation
    • Viscosity
    • (Bubbles)

    12:15
    Lunch Break

    13:15
    Overview and Introduction to Manufacturing Process of PFS

    • Barrel forming
    • Washing
    • Siliconization
    • Sterilization
    • Regulatory guidelines and technical standards: EU / US / ISO / …

    14:15
    Fill and Finish

    • Filling
    • Stoppering
    • Assembly
    • Technical Standards: ISO

    14:45
    Hands-on Session 1


    15:45
    Coffee Break

    16:15
    Hands-on Session 1 (cont.)


    17:15
    Q & A


    17:30
    End of Day 1

  • Friday, 11 September 2020

    9:00
    Recap Day 1


    9:30
    The Syringe (Body) - Example Specification

    • Materials (glass, polymer)
    • Shape
    • Cone
    • Diameter
    • Mechanical properties
    • Chemical Properties
    • Siliconization
    • Impact of different drug properties
    • Dual-chamber syringe
    • Needle shield, tip cap
    • Nest, tub
    • Integrated needles, luer lock adapter, cone types
    • Back stops, rods
    • 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
    • Regulatory guidelines and technical standards: EU / US / ISO / …

    11:45
    Manufacturing Aspects Regarding Filling, Finishing and Assembly

    • Bulk versus nested
    • Nest sizes
    • Standard processing for Rod Insertion and Labelling
    • Handling of syringes considering glass to glass vs. no glass to glass contact

    12:30
    Lunch Break

    13:30
    Assembly of Syringes and Administration Devices

    • Pen Injectors
    • Safety Systems
    • Autoinjectors
    • Manual versus

    Design Independent Assembly


    14:30
    Hands-on Session 2


    15:30
    Q & A


    17:30
    End of Course

Trainers

Michael Andersen
Michael Andersen
Bosch Packaging Scandinavia
Christa Jansen-Otten
Christa Jansen-Otten
West
Klaus Ullherr
Klaus Ullherr
Syntegon Technology (former Bosch Packaging Technology)
Bernd Zeiss
Bernd Zeiss
Gerresheimer Bünde GmbH

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the course participants

    • 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.
  • Who Should Attend

    Who Should Attend

    • Packaging engineers with little or no experience in Pre-filled syringes
    • Pharmacists and formulation developers who want to learn about prefilled syringes as a device
    • Quality, Purchasing, Business Development, Sales

Got a Question? We have answers

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Travel

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.

Novotel Madrid City Las Ventas

Albacete, 1
Madrid, Spain
Phone: +34 91 7247600

Novotel Madrid City Las Ventas
  • Accommodations

    Novotel Madrid City Las Ventas
    Albacete, 1
    Esquina avenida de badajoz
    28027 Madrid - Spain
    Tel: +34 91 7247600
    Fax: (+34)91/7247610
    Email

    This modern hotel is conveniently located for both Madrids Barajas Airport and the city centre. After a day of work or travel you can unwind with a swim in the outdoor pool.Both metro and bus lines run directly to the city centre at Puerta del Sol. The trade fair site of Juan Carlos I is 4 km away, and can be easily accessed via the nearby M30 motorway.

    Enjoy a meal on site at the Insólito Restaurant, which serves Spanish cuisine made with fresh products. You can then relax in the Insólito cocktail bar with a drink. The hotel also has a chill out bar at the pool.

    PDA Europe has reserved a limited number of rooms until the 27th July 2020
    Single Room € 137 per night* 
    Double Room upon request
    *Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service will apply
  • Amenities

How to Get Here

By Air

NEAREST AIRPORT

Adolfo Suárez Madrid-Barajas Airport - MAD
Airport Phone: +34 913 211 000
At 5km / 3 miles

By Car

More information coming soon.

Other Options

Train Station: ATOCHA At 9km / 5.63 miles


Train Station: CHAMARTIN At 4km / 2.49 miles

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro, excluding VAT (21%)

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

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Tel: +1 (301) 656-5900 ext. 115
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