Life Science: Silicone & Long Term Implants

Investing in healthcare and developing our industrial property portfolio in long-term medical implants.

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KEChttps://silicones.elkem.com/EN/Our_offer/KECKEC

 

 

Product(s) / TechnologyProduct(s) / Technologyhttps://silicones.elkem.com/EN/Our_offer/KEC/Pages/Case-Studies/Life-Science--Silicone---Long-Term-Implants.aspx2018-08-17T04:03:05Z

The Challenge

A material supplier that ensure quality, capacity while meeting the most stringent regulations

Manufacturers of long-term medical implants (defined as devices inserted in the human body for 29 days or more) use silicone ingredients and formulations to make a wide range of products, such as tubing and drains, drug delivery systems, pacemakers, vaginal rings (IUD devices) and audiology applications. Silicones used in long-term implants must always be biocompatible, reliable, precise, flexible and durable, efficiently ensuring the protection of sensitive components from corrosive body fluids.

Manufacturers also expect their silicone suppliers:

  • To be attentive to their needs to meet changing market demand

  • To manufacture their products in impeccable clean rooms that meet the highest standards

  • To ensure procurement with available inventory and reliable delivery services

  • To provide support in regulatory matters, with access to documentation and certification to meet healthcare requirements.

Why us

Investing since long in the medical implant market

Elkem Silicones has made significant investments in healthcare ingredients and formulations for several years and is developing its industrial property portfolio in long-term medical implants. Our products have been validated that they meet applicable ISO 10993 or USP biocompatibility testing requirements​. Our ISO 9001-certified manufacturing facility in the US is equipped with ISO 7 clean room manufacturing and ISO 8 clean room packaging and our quality-control systems are managed to comply with standards for long-term medical implants.

Results

Commited to allow you to achieve your goals in the long-term medical implant sector

Our Silbione® Biomedical grade ingredients and formulations meet the highest quality standards. They are custom-designed to provide dependable and safe materials for patients and final users, while being easy to process and cost effective for manufacturers. Our teams are dedicated to working closely with manufacturers, often in long-term R&D partnerships, to provide them with the right products and personalized services.

We are working today on R&D to guarantee current and future needs by developing new products that meet evolving market demand and regulatory requirements. When working with us, you will be in touch with R&D specialists, regulatory experts, qualified technicians and responsive sales and logistics professionals.

To make sure we deliver on time and to your specifications, we have a secured supply-chain scheme to ensure uninterrupted procurement. Our products are monitored continually to comply with Master Access Filing (MAF) requirements with major public health authority bodies, including the FDA in the US.

In short, we are committed to providing you with the products and services you need to allow you to achieve your goals in the long-term medical implant sector.

 Associated Products

 

 

SILBIONE LSR 4301 A/our_offer/Product/90059117/90059118/SILBIONE-LSR-4301-ASILBIONE® Liquid Silicone Rubbers (LSRs) are two-component platinum-catalyzed silicone elastomers designed for liquid injection molding healthcare and medical devices, including applications of less than 30 day implantation in the human body. Available in 01 to 25 durometer Shore A, Elkem Silicones' SILBIONE® LSRs offer the distinctive advantages of easy processing and easy release combined with high performance physical properties. Designed specifically for healthcare applications, SILBIONE® LSRs meet or exceed testing requirements of United States Pharmacopoeia (USP) Class VI. Biocompatibility testing addresses the categories of evaluation for cytotoxicity, skin sensitization and skin irritation specified in ISO 10993 for device use of less than 30 days duration.Bio-compatibilityLiquid Silicone RubberSILBIONE LSR 4301 AFluid
SILBIONE LSR 4370 A/our_offer/Product/90060489/90060490/SILBIONE-LSR-4370-ALiquid Silicone RubberSILBIONE LSR 4370 A