INTRODUCTION

Healthcare Packaging is a highly technical and scientific field, requiring professionals to stay educated and well informed. Proving the necessary protection for state of the art medical devices requires packaging professionals to keep informed of ever-changing regulations, material innovations, testing requirements etc.

This one-day workshop was focused on Sterile Medical Packaging Regulatory and Standards Review, requirements after the new EU MDR as well as Packaging Engineering and Design, Peel Strength & Microbial Barrier.

All attendees were awarded Certificate of Training.

WORKSHOP OUTLINE

Time: 9.00am – 5.00pm

Sterile Medical Packaging Regulatory/Standards Review

  • The new EU MDR / IVDR:
    • Introduction and key considerations
    • The MDR Impact on Sterile Packaging and Global Sterile Packaging Standards
    • Harmonization of EN ISO  standards: the current issues and plans for a new CEN standardization request
  • EN ISO 11607 – Packaging for sterile medical devices- latest revisions to be published end of 2018
    • An introduction to packaging validation
    • Key issues to consider when establishing successful validation protocols
    • Summary of changes of the new EN ISO 11607 revision
  • New MDR requirements for labelling, current plans for developments of new EN ISO symbols
  • Common Materials and Package Formats in Sterile Barrier Packaging
  • Designing for Success – Packaging Design and Troubleshooting Considerations
  • Packaging Test Methods and Validation of Test Methods
    • Science of Peel Strength and effect of using different ASTM F88 techniques
  • Basics of Microbial Barrier & Particle Filtration

TRAINERS’ PROFILE

Thierry Wagner is the Regulatory Affairs Director-Europe, Middle East & Africa for DuPont™ Tyvek® Medical & Pharmaceutical Packaging. Thierry has spent the past 30 years working for DuPont in its polyester films and non wovens businesses in a variety of assignments ranging from process development and project management to operations and business management.

Kevin Grum is part of DuPont’s Medical and Pharmaceutical Packaging team and supports global applications development. Over the past ten years, he has held a variety of roles within DuPont; including manufacturing, quality, and sales.

  • MTaI Medical Packaging Seminar 2018: Present on the stage (L-R), Mr Pavan Choudary, Chairman & Director General, MTaI; Mr Thierry Wagner, Director-Regulatory/Standards, EMEA, EI Dupont Nemours; Mr Kevin Grum, Global Technical Services Leader, EI Dupont Nemours (USA); Mr Diwaker Rana, Chairman, Skill Building Committee, MTaI, while Mr Vishnu Vyas, Co-Chairman, MTaI Skill & Capacity Building Committee is welcoming all the guests.