Applied Silicone Corporation was founded in 1987 to serve health care, medical and specialty silicone markets. By 1999, we had become one of the world's largest independent silicone manufacturers and sold the majority of our Healthcare, Medical and Specialty Silicones business to Rhodia, Inc., which continues to serve most applications. ASC retained certain products and customers serving highly regulated and niche markets that are not served by Rhodia. We have also retained our experienced management team and California production facility. For critical applications, we have substitutes for nearly all Dow Corning Medical Grade Silicones and offer over 100 Medical and Implant Grade products. We are ISO 9001-2000 Quality System certified.
Production Technology/ Industry Commitment
When other suppliers of implantable silicones are unable or unwilling to serve your application, Applied Silicone Corporation may be the solution to your problem. Our unique ability to formulate silicones from basic ingredients allows us to serve the most demanding applications. We have never faltered in our commitment to the medical product industry.
Product Development Excellence
Key members of our staff have decades of training in the medical products arena and have extensive knowledge on material selection, performance, processing techniques, design validation and testing. We understand that a catalog standard product may not meet your demanding product performance requirements. Custom formulations are a specialty of Applied Silicone.
Technical and Production Consultation
Our experienced staff is always available to support customers with state-of-the-art testing and processing techniques. Consulting services include product and process design support, forensic analysis and expert defense witness testimony.
Quality Control
Our ISO 9001:2000 Certification and document control system meet the quality control demands of our customers. Our products are 100% quality tested.
Product Testing and Regulatory Compliance
Designed to meet FDA and ISO 10993 biocompatibility guidelines, this database contains extensive chemical, physical, and biological testing of our products including lifetime rat bioassay studies (which took four years to complete). Our supporting data is compiled into a Master File that is available on an access fee basis. In many cases our customers are not required to perform redundant and expensive physical and pre-clinical testing because we already have data acceptable to the FDA and foreign Health Ministries. Our staff is qualified and ready to assist you with your IDE, 510K, and PMA submissions to the FDA or foreign Health Ministries.