Manufacturers of long-term medical implants (defined as devices inserted in the human body for more than 29 days) use medical grade silicone ingredients and formulations to make a wide range of products:
- Tubing and drains
- Drug delivery systems
- Cardiac resynchronization devices
- Neurostimulation devices
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.
Our Silbione® Biomedical grade silicone ingredients and formulations meet the highest quality standards and are custom-designed to provide dependable and safe materials for patients and final users, while being easy to process and cost effective for manufacturers. We work closely on a case-by-case basis with manufacturers to meet current needs. This is sustained by long-term R&D partnerships to develop new products and meet evolving market demand and regulatory requirements. We also offer complete support services through our worldwide network, including reliable procurement and technical services.
Silbione® Biomedical Grade silicone materials are designed and manufactured to meet the strict regulatory, quality, and purity requirements of the long term implant (≥30 days in the body) market.
- Silbione® Biomedical Liquid Silicone Rubber – LSR
- Silbione® Biomedical High Consistency Rubber – HCR
- Silbione® Biomedical Adhesive
Quality and Manufacturing Standards
- Dedicated Elkem Silicones Quality Management System
- Elkem clean operation standard following GMP principles and ISO 14949 guidelines
- Certified ISO 9001 Manufacturing Facility
- Certified ISO Class 8 Manufacturing Environment
- Certified ISO Class 7 Packaging Environment
- Responsible Care Management System®
Tested according to ISO 10993/USP Class VI:
- 12-week implant
- USP Intracutaneous Reactivity
- USP Acute Systemic Toxicity
- Mutagenicity Pyrogenicity
- Skin Sensitization
- Tissue Irritation
- Device Master Access File (MAF) with FDA CDRH
- Central Catheters
- Wound Drains
- Active Implantable Devices
- Gastric Bands & Balloons
- Cochlear Implants
Click here to contact us to learn how we can help you achieve more than you thought possible with our Silbione® silicone solutions.