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Medical LSR Products
Medical, healthcare and life science companies have high expectations – parts must adhere to increasingly tight tolerances and meet cleanliness requirements. Compared to other materials and processes, medical grade LSR coupled with SIMTEC’s advanced molding technology, exceptionally clean production floor, and highly automated LSR/LSR 2-Shot manufacturing provide greater clarity, chemical resistance, purity, and value for high precision silicone components.
LSR and Environmentally-Controlled Environment
Liquid Silicone Rubber (LSR) is naturally inert, resistant to many substances, and bio-compatible, making it an ideal choice for a wide range of medical and healthcare devices, mother and child care products, sanitary and others with hygienic requirements. For some medical and healthcare products, hygiene is critical and requires production in a hygienic, environmentally controlled environment. To meet these needs, SIMTEC Silicone Parts now offers LSR and LSR Two-Shot molding in its ISO-certified Class 8 Clean Room.
Skin Contact Devices
Unlike many natural rubber/latex products, Liquid Silicone Rubber’s molecular structure is composed of an inorganic backbone, and it is naturally stable, hypoallergenic and bio-compatible, which makes it an ideal material for silicone medical devices with skin contact applications, such as respirator masks.
Flow Control Valves
High precision LSR medical device injection molding enables the manufacturing of perfectly uniform components directly out of the machine. The flexibility of the material is ideal for valves and other silicone medical products which need to yield under pressure but fully close when pressure is released. These valves are precisely and consistently slit in-mold for a perfect contact seal.
Needle Free Valve Sights
LSR injected molded components are the ideal solution for valves, such as the silicone valve example shown here.
Using the right design and LSR material for syringe stoppers ensures optimal sealing pressure and friction. LSR’s low compression set and superior strength make the material perfect for silicone medical products, such as syringe stoppers. Our automated, high-precision injection molding technology ensures consistent, repeatable, high-quality parts. In-line assembly or direct over-molding can add value for syringe stopper applications by reducing or eliminating assembly costs and errors.
Multi-Component Metal/Plastic to LSR Parts
Multi-component molding offers the benefits of improved part quality and consistency. Complicated assemblies can be eliminated by direct mechanical and chemical bonding of LSR onto plastics or metal, thereby reducing assembly time and costs. Over-molding LSR onto surgical tool handles provides added grip strength for increased accuracy and comfort, while at the same time providing a surface that can be sterilized or autoclaved. Multi-component valves and seals also benefit from LSR’s material properties and the reduced assembly steps of LSR 2-Shot medical device injection molding or over-molding.
Connectors and Caps
With the countless options for connector and cap applications, it is beneficial to work with material as versatile as LSR; a material that can be molded into any shape, has different grades of strength and elasticity, and, if the application requires, can be chemically and/or mechanically bonded onto plastics and metals.
Liquid Silicone Rubber is ideal for medical injection molded components, such as tubing connectors. The main characteristics of LSR that benefit this type of application include high purity, transparency, flexibility, and inertness.
LSR provides the required dimensional stability and the high transparency and/or purity for such applications. LSR diaphragm components have been approved and used since the early 2000’s.
Infusion Pumps and Dialysis Filters
Applications for infusion pumps and dialysis include connectors, seals, gaskets, and impellers. Due to LSR’s versatility, along with its ability to sustain its physical and mechanical properties when exposed to many different substances and environmental conditions, LSR can be used for components that come into contact with chemicals, blood, bodily fluids or in any application where LSR’s superior physical properties can be of benefit.
High-compression set, hypoallergenic LSR materials are used to produce medical rubber products such as pull rings, providing the benefits of high purity as well as the mechanical properties that allow the part to yield under specific applied pressures.
For extreme temperature applications where other rubber seals or TPE over-molded components would age and fail over time, Liquid Silicone Rubber provides long-lasting, non-aging mechanical properties that will have minimal variance throughout a vast range of temperatures. LSR can be steam-autoclaved, ethylene oxide (EtO) gas treated, gamma radiated and electron beam (E-beam) radiated.
Precision Equipment Vibration Dampers
In many medical applications, such as high precision electronic or mechanical equipment such as surgical cutting tools, it is very common to use vibration dampers. By strategically positioning LSR as an over-molded layer or a seal at specific points in or on a device, the LSR material can reduce or dampen vibrations.
Gaskets, Seals and O-rings
LSRs provide high purity and chemical inertness while maintaining their low mechanical aging, compression set and stress relaxation. Liquid Silicone Rubber outperforms many other rubbers when used for electronic equipment seals, valves, casings or for pressurized, injection molded, medical device applications.
Our Quality Process
SIMTEC is capable of providing the exceptionally high-quality control processes required by the healthcare and medical device industries. SIMTEC is ISO 9001:2015, ISO 13485:2016/NS-EN ISO 123485:2016, and IATF 16949:2016 certified, and we boast one of the lowest defect rates in our industry.
SIMTEC’s ISO-certified Class 8 cleanroom, as well as sister company Silcoplast’s Class 7 cleanroom in Europe prevent contamination from dust and other airborne particles and meet the ISO standards necessary for hygienic manufacturing.
With our focus on the highly customized production of injection molded silicone medical parts, we tailor our QA process to meet your specific requirements.
Contact SIMTEC to Discuss Your Project Today
Since 2002, SIMTEC has manufactured millions of custom silicone medical devices of all sizes and complexities. Our injection molding production capabilities are unmatched, giving us the ability to turn around high-volume orders quickly. With our office based in Miramar, Florida close to the many South Florida transportation hubs, to facilitate the delivery of your 500,000+ part order to anywhere in the world. In addition to silicone medical device injection molding, we also provide value-added services including prototyping and mold development, packaging, and a variety of other secondary processes.
One of our representatives will be happy to discuss the specifics of your project in detail. Contact SIMTEC by phone or email to get started today.