Introduction / opening of the conference DuPont

Technology overview - Latest developments in Gas and Radiation based Sterilisation technologies
Brian Mc Evoy, Steris

Trends from EU MDR: Survive Transportation Testing “The First Time”
Kevin Zacharias, Lars Kern, Oliver

11.00-11.30

Update on Packaging, Identification and Inspection Systems for Medical Devices (GER)
Multivac

The Impact of the MDR (EU) 2017/745 and of the 2018 revisions of EN ISO 11607 on sterile packaging
Thierry Wagner, DuPont

• Discussing the changes in general safety and performance requirements of the MDR versus the MDD in relation to sterile packaging
• Get an overview of the revised EN ISO 11607 requirements to be published end of 2018
• New requirements for usability evaluations for aseptic presentation
• New symbols and new labelling requirements for sterile products

Lunch

Mini-Pitch Presentations

• FocalSpec, Anecto
• Anecto: “Challenges of the MDR to Sterile Barrier Packaging"
• FocalSpec: New Optical Tomographic Imaging Technology for Online Seal Integrity Inspection

13.30-14.00

Coffee break and tabletop connecting (all)

14.00-14.30

Workshops’ schedule (participants’ choice) - Session A:

• Workshop 1: Root Cause Failure Analysis - predict whether real-life examples will pass transportation testing,
  Oliver
• Workshop 2: Practical Considerations for Sterilisation Validation: Sustainable EO , Radiation, Laboratories,
  STERIS

14.30-15.30

Workshops’ schedule (participants’ choice) - Session B:

• Workshop 3: Focus on Clinical Aspects of Sterile Medical Packaging Complying with the new Medical Device Regulations
  Dupont, N Kaller, T Wagner
• Workshop 4: Definition von Anforderungen für das Verpacken von Medical Devices
  Multivac

15:30-16:30

Presentation of problem/solution by each group 

Dinner

Plant tour
Multivac 

Lunch

"Sterile Packaging requirements in a changing regulatory environment - a Notified Bodies view"
Dr J Havel, TUV Sued

• Packaging requirements in the past and today
• Usability of medical devices: implementation in relation to sterile packaging
• Typical non conformities in relation to sterile packaging

Quantifying the interface between people and packaging: Objectively evaluating behavior and ability in order to design for better health outcomes
L Bix, Michigan State University

Barcode Quality Considerations for Packaging requiring serialisation or UDI
Videojet

• Various global legislations having an impact on printing quality of barcodes
• Key influences on barcode quality: what is the formula for applying a high-quality barcode?
• ISO 15415 – What is ISO 15415, what parameters are measured, which causes could lead to poor grading & reading results & how to optimize
• Testing quality – How can you ensure that durable high quality barcodes are printed and which tests can be performed to ensure your codes withstands influences along the supply chain such as condensation or UV radiation.

Conclusions