Implantable Silicone Materials Introduction
Implantable silicone materials can be used inside the body for varying periods of time, based upon the needs of the medical device and the limitations of the material chosen. These implantable grades of silicone will not be rejected by the body or cause infection, as they are biocompatible for use in humans.
Silicone manufacturers will perform USP tests to clear the material for use in humans. However, this does not mean that materials testing of your medical device should be omitted; it still needs to be completed. Certain silicone material manufacturers require approval of your implantable device application before even supplying material. Other material suppliers have excluded certain implantable applications from using their material. The purpose of this is to minimize the silicone suppliers exposure to risk.
Albright fabricates tools and molds implantable medical devices made of silicone on a daily basis. Implantable silicone materials are available in liquid silicone rubber (LSR) and high consistency rubber (HCR). We work with implantable silicone materials ranging from 10 Shore A Durometer to 80 Shore A Durometer. In addition, we have partnered with a silicone dispersion companies to provide colors that will meet FDA guidelines and pass USP Class 6 tests.
Grades of Implantable Silicone
Short-Term Implantable Silicone – This grade of silicone can be implanted in the body for 29 days or less. Typical applications include punctal plugs, surgical tools and instruments, shunts, and certain types of catheters.
Long-Term Implantable Silicone – This grade of silicone can be implanted in the body for 29 days or longer. These materials can remain in the body until end of life. Typical applications include cardiovascular, knuckle, ocular and toe implants.
Implantable Silicone Molding Processes
Albright will mold your parts in implantable silicone material in its controlled environment room. Our controlled environment room is class ISO 7 compliant. We are able to perform compression, transfer and injection molding processes for implantable silicone medical devices inside our controlled environment room. In addition, we are able to provide overmolding and micro molding services in implantable silicone materials. We provide complete traceability of materials from source to delivery for all of our molding processes on each order completed using implantable grade silicones.
All of the implantable silicone materials are mixed in our controlled environment room. When manufacturing implantable silicone parts, all processes are completed in the controlled environment room. These processes includes mixing silicone, molding, inspection, post baking, washing in pharmaceutical grade alcohol, final inspection and packaging. We can recommend suppliers for sterilization of your parts if you do not already have one in mind. Our comprehensive ISO 13485:2003 quality management system will ensure that your implantable silicone medical devices and surgical instruments meet all acceptance criteria from prototypes through production.
If you are in need of rapid implantable silicone prototypes or low-volume production parts look no further. Albright is able to provide rapid prototypes with certifications and complete traceability in 15 business days or less. Depending on the volume of your production order, our standard delivery is 15 business days, however 5 and 10 day expedites may be available for low quantity. Contact our sales department today to discuss your next implantable silicone molding project at 978.466.5870 or via email at firstname.lastname@example.org.