The Rubber Group (TRG) has received a trademark for MedElast™ silicone rubber from the United States Patent and Trademark Office (USPTO). TRG’s medical silicone complies with USP Class VI requirements for biocompatible elastomers that are safe for use when contact with human tissues and fluids is possible. USPTO issued TRG a trademark on October 15, 2024 ( #98310546).
Applications for MedElast silicone rubber include seals, gaskets, tubing, O-rings, sterilization mats, vibration pads, and other components for medical devices and equipment. TRG can produce MedElast parts using injection molding, compression molding, or transfer molding and offers value-added services such as inventory management, packaging, and shipping to medical manufacturers.
Keep reading to learn more and contact TRG for molded medical products.
MedElast Silicone Rubber and USP Class VI
MedElast silicone rubber complies with requirements defined by the U.S. Pharmacopeia (USP), a non-profit organization whose standards inform decision-making at the U.S. Food and Drug Administration (FDA). There are six USP Classes for plastics, a category of materials that includes silicone rubber. USP Class VI contains the most rigorous testing requirements.
As a USP Class VI elastomer, MedElast silicones have low levels of chemicals and extractables that can migrate from a material at elevated temperatures or with surface exposure. USP VI testing evaluates the biological reactivity of materials and ensures that compliant elastomers have clear histories of compatibility and have been tested for toxicity.
Four USP Class VI Tests
There are four aspects to USP VI testing.
- In vitro testing exposes the USP Class VI material to a series of extraction solvents to simulate the potential interaction between the material and bodily fluids.
- Biological reactivity testing subjects the extracted solutions to additional tests to assess the potential toxicity of substances that may have leached from the material.
- System injection testing injects the extracted material into test animals, which are then observed for signs of systemic toxicity.
- Implantation testing involves the short-term implantation (less than 28-days) of the material into living animals to observe inflammation or other adverse reactions.
Contact TRG for Molded MedElast Products
The Rubber Group is an expert in molding USP Class VI elastomers for medical, healthcare, pharmaceutical, and biopharmaceutical products. Contact TRG for additional information about MedElast silicones and to discuss your application requirements.