Specialty Silicone Fabricators is a US based, quality-driven, innovative manufacturer serving the medical device and pharmaceutical markets. SSF’s mission is to be the worldwide leader in manufacturing medical silicone, bioresorbable materials and medical device-drug combination components. We will achieve our goal by creating value for our customers via innovation, quality and service.
At SSF, we are dedicated to a manufacturing philosophy based on a total, collective commitment to quality at every level. We believe that "QUALITY" is an attitude that is developed and applied at all levels through pride of workmanship, recognition of performance, and a positive and healthy work environment. As a matter of fact, we build quality into our processes by exposing problems and then identifying and fixing the root cause.
We provide solutions, inspire trust, seek continual improvement and are devoted to developing close relationships with our customers for mutual success. We improve our operations continuously through a constant focus on eliminating waste, taking care of the root causes of problems and incorporating standardized and stable processes.
We know that to keep abreast of such a quickly evolving field we need to continue learning, gathering in-depth knowledge and devoting resources to help grow our company. We consider ourselves a learning organization. We develop exceptional people and teams through both internal and external training, coaching and mentoring. Our employees are encouraged to take steps for self-improvement, and our clients gain the benefit of that freedom.
The culture at SSF is one of respect! You as our client will recognize this immediately in the way that our team works with you. Respect at SSF is displayed by humble leadership. Elevated egos have no place in our culture. We break down departmental barriers and involve everyone in our value-creation process.
We like to say: "We don’t sell products, we sell service." The world of medical devices is a very service-intensive field. At SSF, we believe the service we provide our customers exceeds that of any of our competitors. When we ask our customers what they consider our greatest strengths, they typically answer: Quality, broad capabilities and great customer service.” We couldn’t be happier with that evaluation. We truly believe that our technical expertise is unsurpassed and our people provide, at every turn, the vision, collaboration and commitment to help our clients do amazing things. At SSF, we work with you to bring silicone to life.
SSF provides a complete array of development and production capabilities from raw material selection to completely finished, packaged and sterilized medical devices and combination products.
Leveraging our numerous patents, we’ve earned the reputation as an innovator in silicone extrusion, micro-molding, sheeting and dipping. SSF provides unique contract manufacturing services to clients in both the medical device and pharmaceutical industries. Our services include the assembly, packaging, and testing of complete medical devices as well as design assistance and manufacturing of cutting edge drug-device combination products.
Our most current projects involve the fabrication and assembly of Class 3 devices intended for long term human implantation. No longer limited to silicone elastomers, today we’re involved in projects employing novel biomaterials such as biologically-derived gels, hybrid thermoplastics, and carbon composites to name a few. Recent projects have included manufacturing shunts made from a porcine-derived biomaterial and casting bioresorbable films for orthopedic applications.
Paso Robles Facility
Our facilities at Paso Robles continue to push the boundaries of silicone fabrication. We manufacture silicone, thermoplastic and silicone-urethane hybrids of medical components and other silicone based products. We can extrude, mold, calender, and dip coat silicone and thermoplastics to the most demanding specifications using our patented and proprietary technologies.
As a matter of fact, our exponential growth left us bursting at the seams at our old facilities so we built a 103,000 square foot manufacturing facility. The new facility helps us meet the growing demand for medical silicone device components and support new innovative processing technologies. By building the facility from the ground up it has provided SSF the opportunity to create a flexible manufacturing environment maximizing lean manufacturing techniques.
Specialty Silicone Fabricators
3077 Rollie Gates Dr.
Paso Robles, CA 93446
Our Paso Robles facility is ISO 13485 and ISO 9001 certified and licensed by the state of California for manufacturing components.
Our 55,000 square foot Tustin facility includes 4 clean rooms totaling over 18,000 square feet of ISO 7 manufacturing space. Medical device assembly work is organized into dedicated work stations and is conducted in one of our three large clean rooms.
The compounding of active pharmaceutical ingredients, that is the mixing of the drug into a carrier material, is confined to a fourth clean room or other dedicated and segregated spaces, purposefully constructed with dedicated air handling systems as well as other design features necessary for proper API handling. Four specialized mixers are located in the fourth clean room and available to our clients for API mixing. Factors such as the viscosity of the carrier material as well as the type and concentration of the API will dictate our choice of equipment. Other equipment such as extruders, presses, and thin film processors are brought into this clean room as needed.
Specialty Silicone Fabricators
2761 Walnut Avenue
Tustin, CA 92780
SSF in Tustin, CA is ISO 13485 certified, registered with the FDA and licensed by the State of California for Medical Device and Drug Manufacturing.
Elk Rapids Facility
Our Elk Rapids Facility provides contract manufacturing for components from silicone prepared by molding, extrusion or dip coating.
Specialty Silicone Fabricators
222 Industrial Park Dr.
Elk Rapids, MI 49629
Our Elk Rapids facility is ISO 13485 and ISO 9001 certified.