Ahead of Extractables & Leachables USA 2016 this May, we spoke with Xuejun Liu, Senior Scientist at Johnson & Johnson, to discuss packaging materials for permanently implantable medical devices, the extractable profiles and risks associated with this, research methods & best practice, the future of extractable profiles and more.
Your presentation will look at packaging materials for permanently implantable medical devices and their extractable profiles, could you expand on what this really means?
The permanently implantable medical devices that I focus on are surgical sutures. Two case studies related to chemical evaluation of the aqueous extractables from suture packaging materials will be presented. The first example is an unprinted paper label. It is used on the outside and/or inside of various suture product packages. The second example is about a low density polyethylene (LDPE) foam that is used for “parking” suture needles.
Why is your presentation a really key topic to be discussing and what are some of the risks that you will be looking at?
Surgical sutures are the most widely used devices in wound closure. Packaging materials for surgical sutures include various components, such as folders, trays, lids, and labels, which are made from a wide range of materials (foil, polymeric materials, coated paper, etc.). The packaging materials are also exposed to different sterilization processes including high dose gamma irradiation. Extractables/leachables of suture packaging materials are important factors to consider as they could impact efficacy and safety of the final devices.
How are you and Johnson and Johnson ensuring that the best and most efficient research is being carried out in E&L testing?
To ensure quality and efficiency, we follow the guidance of ISO 10993 and relevant and applicable guidance documents. ETHICON is well equipped with various state-of-the-art analytical techniques. ETHICON analytical team collaborates with internal preclinical subject-matter experts closely to design E&L study strategy and ensure the study results serve its purpose for risk assessment.
Where do you foresee extractable profiles for packaging materials headed in the future?
The extractable profiles for packaging materials are mainly determined by the nature of the materials, processing, and sterilization. The emerging of innovative medical device products, such as combination products, and the use of sustainable packaging materials will pose additional challenges for medical device packaging.
What are you most looking forward to at the E&L US 2016 conference?
I am interested in hearing regulatory updates regarding to E&L analysis for medical device and pharmaceutical products. I am also looking forward to exchanging best practises with other industry leaders in the field of E&L analysis.
Xuejun will be presenting as part of the Packaging Materials and Methods session on conference day one, alongside representatives from C&M Technical Consulting, GlaxoSmithKline, Clariant, Pfizer and iuvo bioscience.
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