The Silbione® Difference...A Brand You Can Trust
for high quality healthcare silicone solutions

Call: 866-474-6342
silbione@elkem.com

The Silbione® Difference

Implantable Devices

Impatable Devices

Manufacturers of long-term medical implants (defined as devices inserted in the human body for more than 29 days) use silicone ingredients and formulations to make a wide range of products, such as tubing, drains, shunts, active implantable and audiology 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 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.

 

Product Range

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®

Biocompatibility

Tested according to ISO 10993/USP Class VI:

  • 12-week implant
  • Hemolysis
  • USP Intracutaneous Reactivity
  • USP Acute Systemic Toxicity
  • Cytotoxicity
  • Mutagenicity Pyrogenicity
  • Skin Sensitization
  • Tissue Irritation

Masterfile Support

  • Device Master Access File (MAF) with FDA CDRH

Application Solutions

  • Central Catheters
  • Wound Drains
  • Active Implantable Devices
  • Gastric Bands & Balloons
  • Pacemakers
  • 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.