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Bio-based plastics for medical devices: A case study

Author:Philip Smith

Pages:1

Published:03/05/2024

Presenting alternatives to injection molded plastics

 

Respiratory Drug Delivery 2024, Tucson, Arizona, May 5-9

This paper presents the alternatives to injection molded plastics, and tracks the application of bio-based plastics through to acceptance for use in a proprietary Vectura DPI, the Open Inhale Close (OIC) device, considering the regulatory challenge posed in effecting this change.

In conclusion, short-term steps to improve the sustainability of medical devices can be taken now. The implementation of bio-based plastics is best done at the early stages of development, but slot in solutions, where available, allow bio-based material selection, just prior to Design Verification and Validation in the development cycle.

The question of applicability to marketed devices is an open one, and where next steps in the approach to regulation are required. Understanding among all stakeholders is needed to allow the considerable impact of legacy plastics supply to be reduced using Bio-based plastics, and concerted long term change is needed across the industry to minimize the impact of single use plastics at end
of life.

 

REFERENCES

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3. Celanese launches POM ECO-B as mass-balance bio-based option for existing products [https://www.celanese.com/news-andmedia/2020/November/celanese-launches-pom-eco-b], accessed February 13, 2024.
4. Ineos Styrolution recycled and bio-attributed styrenics [https://styrolutioneco.com/eco-products.html], accessed February 13, 2024.
5. Ellen MacArthur Foundation, Enabling a circular economy for chemicals with the mass balance approach [https://www.ellenmacarthurfoundation.org/white-papers-and-articles], accessed February 13, 2024.
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7. FDA Guidance (2017): Guidance for Industry and Food and Drug Administration Staff. Deciding When to Submit a 510(k) for a Change to an Existing Device.

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