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Critical Material Performance Considerations for Successful Development, Design and Validation of Medical Device Packaging: A Global Perspective

Wes Peer  (Application Development Scientist, Eastman Chemical Company)

Renato Acosta  (Technical Service Engineer, Eastman)

Tina Barrett  (Product Stewardship and Regulatory Affairs, Eastman)

Location: 211AB

Date: Tuesday, February 11

Time: 11:45 am - 1:00 pm

Track: Lunch & Learn

Vault Recording: TBD

Audience Level: All

"Packaging materials are at the core of what makes it possible to successfully deliver a sterile device to the healthcare facility and, most importantly, to the patient. In this session we will review key factors and considerations for thermoformed packaging design, development, validation, commercialization and compliance. Participants will come away with a greater understanding of the many important aspects involved in selecting the right packaging materials, including critical performance criteria for the application. Topics related to regulatory compliance and the circular economy will also be covered.

The key focus of this session will be on risk mitigation — how to ensure optimal packaging performance in terms of sterility of the barrier, but also how to achieve a holistic approach to cost avoidance through careful consideration of materials and suppliers. From proper handling of polymeric raw materials, to sheet extrusion and thermoforming -- the right decisions can help influence the integrity and cost effectiveness of the final packaging. However, the challenge does not end once the new material has been qualified and validated. To help ensure that each sterile package produced continues to deliver on its promise, it’s important to also consider the product life after validation. Given shifting regional regulatory requirements, notably the EU MDR, a medical device manufacturer can safeguard long-term success by choosing a resin supplier with dedicated services and support for the medical industry globally. "