Medical grade silicone elastomers for the manufacturing of In Vitro Diagnostic devices

Manufacturers of diagnostic devices use medical grade silicones in the production of a wide range of products including point of care testing (POCT) devices.

In Vitro Diagnostics (IVD) point of care test (POCT) are an emerging trend in the field of diagnosis as they include disposable and home health options for the patient. POCT devices are convenient since they are easy to use, eliminate the need of traveling to medical facilities and provide the test result within minutes. Among others, microfluidic cartridges are the heart of POCT devices. Condensed on a few centimeters, these chips enable sample drawing, sample preparation and parallel analysis of various parameters. Silicones facilitate the fabrication on a micrometer scale and integration of valves, micropumps and other components. Utilizing Silbione™ silicone materials will provide various benefits to manufacturers of In vitro diagnostic point of testing devices including biocompatibilty and application-specific solutions to limit absorption of both proteins and drugs.

At the beginning of every treatment, there is a diagnosis. Whether by imaging in the local doctor’s office, invasive tissue sampling at the hospital or by point-of-care-testing right at the site of the patient: the diagnosis gives certainty to the Healthcare professional and provides feedback for the most suitable treatment against a specific disease. In this context it is important that the diagnostic device functions reliably. This requirement is not only valid for the diagnostic assay but includes every single component, like valves, tubes and the housing of the device as well.

Manufacturer of diagnostic or sensory devices use silicone elastomers among others in the production of disposable and home-health devices, microfluidic chips, gaskets and cushioning pads. For many applications the material of choice are silicone elastomers, not only because of their unique properties and ease of processing, but in particular due to its inertness. 

In this context, Elkem’s Silbione™ brand offers a powerful toolbox for the development and large-scale production of diagnostic devices and wearable solutions. Our product portfolio is ranging across the entire silicone technology tree and offers solutions for each stage of the development:

Silbione™ Biomedical grade silicones meet the highest quality and manufacturing standards, complying with the Elkem Silicones Quality Management System. This includes:

  • Inhouse clean operation standards, applying the principles of Good Manufacturing Practices (GMP) for medical devices and ISO 14949 guidelines
  • Certified ISO 9001 Manufacturing Facilities
  • Certified ISO Class 8 Manufacturing Environments
  • Certified ISO Class 7 Packaging Environments
  • Application of the Responsible Care Management System®

The biocompatibility of Silbione™ Biomedical grade silicones is tested according to ISO 10993/USP Class VI procedures, which include:

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

Silbione™ medically implantable silicones are also given full Master-file Support through Device Master Access Files (MAF) at the FDA Center for Devices and Radiological Health (CDRH).

At Elkem silicones, we are dedicated people located around the globe, committed to your success. Whether you are looking for a product recommendation, for customized silicone solutions, or for regulatory support, we have the people in place when and where you want them. If you have a medical device related project, contact us and our experts will be there to help.