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Parenteral Drug Association Connecting People, Science and Regulation ®

Container Closure Development

Nov 09 - Nov 09, 2017 |
Nov 09, 2017 |
Austria Center Vienna | Vienna, Austria
  • Education
  • Europe
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The course will give an overview on how to develop a container closure system for parenteral products. Starting with setting up of a product profile of the final product container, all aspects will be covered like selection of materials, assessment of container closure systems, specification and documentation of components and entire systems. In addition, current hot topics such as glass delamination and container closure integrity testing will be discussed.

For all topics of the agenda presentations will be given. The participants are invited to add own experience, ask questions and offer issues to be discussed within the group and/or with the trainer. The intention is to work in an open workshop-like atmosphere.

Who should attend?

  • Scientists in Drug Product Development
  • Scientists/ Engineers in Packaging Development
  • Regulatory Affairs Experts

Learning Objectives

  • Set-up of a target product profile of a container closure system
  • Select appropriate container closure materials, components, and systems
  • Apply the appropriate regulations and standards to container closure systems for parenteral formulations
  • Prepare a development plan of a container closure systems from the early development until market phase
  • Specify container closure system regarding technical aspects and regulatory requirements
  • Understand compendial requirements and quality as well as technical standards regarding container closure components and systems

Instructor

Jörg Zürcher, Senior Scientist, Bayer
Jörg Zürcher is a pharmacist by education. After his studies and PhD thesis at the Free University in Berlin, he started his career in the pharmaceutical industry 1990 with the former Schering AG. He is responsible for the development of container closure systems and application devices at Bayer HealthCare and has more than 25 years’ experience in that field. His current focus is the development of systems/devices for liquid and parenteral as well as ophthalmic dosage forms.


Thursday, 9 November 2017

9:00
Welcome & Introduction

9:10
Setting up a Target Profile

  • Influence of formulation (small molecule, biological)
  • Use of product (patient, nurse, physician....)
  • Regulatory requirement
9:30

Material Selection

  • Ph.Eur. / USP / JP
  • Plastic vs. glass
  • Coating of material
  • Stopper material
10:30
Coffee Break

11:00
Selection of Packaging Solution

11:30
Assessment of Packaging Solutions – Development Data

  • Testing of injection vials/bottles and their respective components
  • Testing of pre-filled syringes (PFS) and their respective components
  • Extractables & Leachables (E&L) testing
  • Mechanical and functional testing
12:30
Lunch Break

13:30
Manufacturing of Packaging Solutions

  • Test runs
  • Process validation (risk assessment, critical parameters)
  • Container closure integrity (physical vs. microbiological testing – USP 1207)
  • Shipping test for PFS

14:00
Setting of Specifications

  • Technical drawings
  • Technical / quality specification
  • Testing standard, defect evaluation list
  • Examples
15:00
Coffee Break

15:30
Preparing the Submission

  • Relevant eCTD sections (drug substance and drug product)
  • Regulatory drawings
  • DMF for US

16:00
Routine and Release Testing

  • Certificates
  • Routine E&L testing
  • Reduced testing

16:15
Change Management

  • EU requirements

16:30
Wrap-up, Discussion, Q & A

17:00
End of Training Course

4 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

845 Euro

All fees given in Euro and excluding VAT (23%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Austria Center Vienna
Internationales Amtssitz- und Konferenzzentrum Wien, AG
Bruno-Kreisky-Platz 1
A-1220 Vienna

Hotel Accommodation

optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2017 . We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting an official PDA Europe hotel.

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://www.pda.org/docs/default-source/website-document-library/eu-conferences/2017/the-universe-of-prefilled-syringes/registration-form.pdf

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