PDA EU00168 Test Methods for Pre-Filled Syringe Systems

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Program Highlights
 

The course is an interactive presentation on prefilled syringes, including ISO compliance testing. Participants will benefit from first-hand information from the presenter based on practical experience. The lecture covers the life cycle of a PFS from idea to final marketed product.

Upon completion of the course the participants will have solid knowledge of

  • Materials used for PFS Systems
  • Luer Cone and Luer Lock Compliance Testing
  • Requirements for the empty sterile sub-assembled syringe ready for filling
  • Test Methods for Drug Product Filled Syringes
  • PFS used in Delivery Systems

Contact

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
[email protected]
Registration Customer Care

Standard Pricing

Standard Member Price

€500

GovernmentMember Only

€500

Health AuthorityMember Only

€500

Early Career ProfessionalMember Only

€500

StudentMember Only

€500

AcademicMember Only

€500

Non-Member

€500

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

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 [email protected] 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, 7 October 2021

14:00
Introduction

Session 1: Syringe Systems and Materials

  • Glass / Plastic Materials
  • Glass / Plastic Syringe Manufacturing Processes
  • Advantages & Disadvantage of Syringe Materials

Session 2: Luer Compliance Requirements

  • ISO 80369-7 Dimensional Requirements
  • ISO 803697 – 20 Testing Requirements
  • Relation to ISO 11040-4 /-6 (Glass / Plastic Syringes)

Q&A Session

16:30
End of Day 1

Day 2

Friday, 8 October 2021

14:00
Welcome Day 2

Session 3: Empty Pre‐assembled PFS

  • ISO 11040-4 / -6 Testing Requirements
  • Test Method Descriptions / Explanations

Session 4: Final Filled PFS

  • ISO 11040-8 Testing Requirements
  • Device Implementation

Q&A Session

16:30
End of Course

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