SSF’s engineering resources support production and engineering services. For production projects our engineering staff is intimately involved in process design, process development, material selection and validation. Our engineering staff has years of experience and familiarity with the processes ensuring that you receive both high value and consistent high quality output. If you are in the early phases of product realization or in the early stages of the Design Control process then Engineering Services is an option where SSF can provide valuable assistance in: Product design ● Design for manufacturability ● Feasibility testing ● Design confirmation testing ● Rapid prototype builds ● Material testing ● Performance testing.
At SSF over 90% of the total tooling requirements are designed and built in-house. SSF’s unsurpassed technical expertise combined with state-of-the-art CAD/CAM software and equipment facilitates our unparalleled tool making capabilities. We use troubleshooting software for either prototypes or full scale production. We offer you quick prototype to high volume automated production tooling to help you achieve your goals. If you are in the early phases of project development, we can work with you to translate your concepts and ideas into prototypes that meet your specifications. Our team of designers, toolmakers and process design engineers collaborate to ensure a smooth transition from design to finished product.
SSF can support all stages of manufacturing operations: from manual assembly to fully automated device and product manufacturing. We employ highly skilled operators and offer high precision manual manufacturing operations. SSF follows Lean Methods providing you with continual improvement in cost and yield. SSF can help in all aspects of your product development and production. In our manufacturing process we provide traceability of all components and materials. We have microbial control monitoring including product bioburden, pyrogen testing monitoring capabilities. We manufacture in an ISO Class 7 (Class 10,000) clean rooms, ISO Class 8 (Class 100,000) clean rooms and clean rooms.
SSF is unique among medical contract manufacturers in that we collaborate daily with both device and pharmaceutical businesses. Recent projects include the assembly of multi-electrode neurological implants, the manufacture of ocular shunts made from biologically derived polymers, and thin film casting of drug eluting, bioresorbable orthopedic implants. SSF is appropriately licensed and registered for both device and drug manufacturing. Our business model, quality system, and facility layout are all designed for flexibility to meet the requirements of our clients. SSF’s Engineering and Quality Departments assist our drug-device clients in design, feasibility, prototyping, clinical builds and commercial release.
Dipping is a specialized process where a form is immersed into silicone and then withdrawn. This results in the thin film being cured. Dip coating is a process where the thin silicone film remains on the object. Other dip coating applications involve encapsulation and potting. Advantages to dipping include thin cross sections, large aspect ratios, thin films, low tooling costs and quick turn prototypes. Dipping can be divided into: Shell dipping • Balloons • Thin walled reservoirs • Breast envelopes Over-coating • Dip coated blades and needles • Encapsulation • Potting
At SSF, we can develop sheeting from both high consistency silicone rubber (HCR) and from liquid silicone rubber (LSR). Our expertise in this area is demonstrated by our Gel-Spandex sheeting (US Patent 7,645,916 B2) and our patent pending on LSR reinforced sheeting. We can consistently maintain sheeting thickness from 0.0254mm (0.001") to 5.08mm (0.200") and can fabricate to your precise specification. Our silicone sheeting is latex-free and can be laminated to many substrates. Sheeting and film production are carried out in cleanrooms certified Class 10,000 / ISO 7. Additionally, all production is FDA QSR, 21 CFR Part 820 and cGMP compliant.
When you partner with SSF, you are working with molding experts who intimately understand the regulatory requirements necessary for validated production for medical applications. Our quality system is designed to ensure our on-going processes are controlled properly to maintain the integrity of those validations. All of our molding can be performed in an ISO 7 or 8 clean rooms coupled with the use of scientifically designed experiments, measurement studies and statistical analysis required for your medical device needs. Silicone materials are typically molded by the following methods: Liquid Injection Molding (LIM), Transfer Molding, Compression Molding. We’ll recommend the type of molding that best suits your needs.
At SSF, our extrusion process is unrivaled. We can vary the inside and outside to your exact specifications. Nothing is too small, too fine or too complicated for our engineers and designers. We are able to layer cross sections from many types of materials to create a product with unique features. Our processes can create a myriad of designs – thin walled, thick walled, ribbed, perforated or split. And we can design any profile of formed extrusions including bends, coils, or pigtails in single or multiple planes. We’ve even developed close tolerance multi-lumen silicone tubing with inner lumens that spiral or twist to a desired pitch. We fabricate to your personal specifications.