When it comes to medical manufacturing, companies have a variety of methods to choose from ranging from molding to machining to 3D printing.  The following explains why silicone injection molding is a great choice for medical manufacturing – and why it may be the best option for your next project.

Why Medical Manufacturing Prefers Silicones

Silicones have long been a popular material for medical devices due to their durability, wide temperature range, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, and compatibility with many sterilization methods. Furthermore, silicone has a unique molecular structure, namely its silicon-oxygen backbone, that results in several excellent properties that are desirable for medical manufacturing such as:

  • Superior Biocompatibility: medical products often come in contact with the human body – either externally on a patient’s skin or internally as an implant that contacts tissue and fluids. Silicones are compatible with human tissue and body fluids, have a very low tissue response when implanted, and do not support bacteria growth. Additionally, medical-grade silicones, such as Liquid Silicone Rubber (LSR), have undergone stringent purity and biocompatibility testing that make them suitable for short and long-term usage. Simply put, silicones are unmatched in their biocompatibility, making them an excellent option for medical manufacturing.

 

  • Withstands Sterilization: medical grade material must be able to withstand sterilization in order to minimize contaminants and the risk of infections. Devices and products made of medical grade silicone are easily sterilized and resist bacteria growth. In fact, medical grade silicones are often processed in special facilities called cleanrooms that reduce the potential for contamination. For example, all of ProMed’s manufacturing facilities are equipped with certified class 10,000 / ISO Class 7 cleanrooms, demonstrating a strong commitment to quality.

 

  • Superb Stability: silicone is known for its resistance to UV, weather, and other environmental conditions that tend to age materials, leading to a high level of stability and long-life span for silicone products. These characteristics are critical for a number of medical devices such as implantables.

 

  • Broad Temperature Range: compared to other materials, LSR and other silicones have excellent thermal stability. LSR blends are able to withstand high temperatures without deforming or melting. As for low temperatures, LSR maintains its flexibility and does not become brittle and vulnerable to breaking like thermoplastic elastomers.

 

  • Low Viscosity: the low viscosity of LSR makes it a great material for making medical devices via silicone injection molding, since the LSR can easily flow into and completely fill molds with relatively low injection pressures, even those with small, complex, or high-tolerance features. A lower viscosity also makes it easier for manufacturers to mix in additives including colorants, desiccants, barium, and pharmaceuticals such as hormones or steroids. For these reasons, LSR is a great option for medical devices such as combination products.
  • Quick Cure Rate: one of the benefits of silicones, like LSR, is that it cures faster than most other rubber materials – in some cases in only seconds. Additionally, due to the highly automated nature of silicone injection molding and the potential for 24/7 manufacturing, high volumes of medical products can be produced in a short period of time – adding to its popularity.

Looking for a reliable and proven partner for your next medical manufacturing project?

Contact ProMed to learn about the range of solutions and materials we offer as well as our decades of silicone injection molding experience.

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Advantages of Silicone Injection Molding in Medical Manufacturing

For companies seeking high-quality and cost-effective products for the medical sector, silicone injection molding is an ideal solution.  Silicone injection molding has several benefits compared to other molding processes, and the following is why this method is a great choice for medical manufacturing. To learn more about ProMed’s medical injection molding and our commitment to quality, watch our short video.

 

  • High Quality & Very Reproducible: silicone injection molding produces products that are virtually identical from part to part which provides excellent brand consistency and part reliability during high volume runs – this is especially crucial for devices used in the medical industry. High reproducibility also allows for production to be scaled up to very large volumes, resulting in low costs per unit once the upfront equipment set-up costs are paid.

 

  • Excellent Versatility: silicone injection molding is able to manufacture a wide range of part sizes, materials, and colors. Additionally, this form of molding allows for the use of multiple materials simultaneously, allowing for a high degree of customization.

 

  • Able to Produce Complex Parts: silicone injection molding is typically performed at high pressure which forces the silicone into small crevices in the mold (that other molding processes are unable to reach), enabling the production of intricate and complex parts.

 

  • Efficient Production & Low Cost Per Unit: silicone injection molding is a very fast process that quickly generates high volumes compared to other molding methods, making injection molding a more efficient and cost-effective solution. Additionally, silicone injection molding is highly automated via the use of machines and robotics, requiring less oversight by operations personnel. Automation reduces labor costs which further decreases the manufacturing costs per unit, especially for high volume production.

 

  • Low Waste Generation: silicone injection molding manufactures smooth products that have minimal finishing requirements after removal from the mold – resulting in less waste generation compared to other medical manufacturing techniques. In some cases, silicone injection molding waste is able to be reused, resulting in a more environmentally-friendly and lower cost process.

ProMed – Your Silicone Injection Molding Partner

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

We can identify the right medical manufacturing solution for any project. We have extensive experience in a wide range of silicone injection molding techniques including:

  • Automated Injection Molding
  • Multi-cavity tooling
  • Micro molds and micro molding
  • Servo-controlled de-molding capabilities
  • Insert molds, overmolds, and automation integration
  • Transfer molding
  • Compression molding

 

Click here to see why ProMed is your silicone injection molding partner. Contact ProMed today at 763-331-3800 to discuss your next medical manufacturing project.