SSF specializes in the custom fabrication of silicone elastomer components through silicone extrusion, molding and sheeting for medical applications. Offering full product design and manufacturing services, from prototype and testing, to production, assembly, packaging and shipping — all ISO 9001:2008 and 13485:2003 Certified.
We provide a complete FDA registered, ISO certified "design through distribution" solution for medical products OEMs.
Silicone elastomers, adhesives, gels, and fluids are crucial biomaterials in medical devices and pharmaceutical applications as can be seen in our Orthopedic, General Surgery and Cardiology sections in our web site.
Capabilities include:
Extrusion: The extrusion process is able to produce single lumen and multi-lumen tubing with varying diameters. We also have Geo-Trans® which enables the cross-sectional profile of a silicone tube to change “on the fly” during extrusion.
- ID/OD Extrusion
- Geo-Trans®
- Multilayer Extrusions
- Profile Extrusions
- Ribbon & Tape
- Spiral Twist Extrusion
- Sponge-Foam Closed Cell Extrusion
- Polyurethane Extrusion
Molding: We use state of the art molding presses and inspection equipment coupled with the scientific use of designed experiments, measurement studies and statistical analysis to deliver outstanding silicone molded parts.
Quality SSF is certified to recognized industry quality system standards and complies with national and international standards.
- State of California FDB Device Manufacturing License Number
- ISO 13485:2003 Medical Devices- Quality Management Systems
- ISO 9001 Certificate
- Process Validation
- Rapid Prototyping
- Material Selection Support
- Lean Manufacturing
- Tool Making
- Over-coating
- Printing
- Cutting
- Tipping
- Assembly/Packaging
Submit a Drawing - SSF can help in all aspects of your product development and production. To keep your product development on schedule, we can offer you technical expertise such as design modifications for manufacturability, material selection, tooling, processing, testing, assembly and packaging. Click here to submit a drawing.
SSF Tustin provides innovative quality medical device assembly and packaging. It is a USA ISO 13485 certified domestic company with all services performed in California. The 55,000 square foot, FDA inspected, registered and Japan PAL (Pharmaceutical Affairs Law) compliant facility has the capacity and the adaptability to meet and exceed your needs.
Capabilities include:
- Certified ISO Class 7 Cleanrooms
- Combination Products
- Drug Eluting Silicones
- Custom Assembly
- Microscopic Assembly
- Bonding Operations Inspection & Testing
- Pouch & Tray Sealing • Labeling
- Custom Packaging
- Sterilization
- Product & Component Traceability
- Direct Third Party Shipping
- Warehousing