When it comes to material selection, the medical industry is one of the most demanding sectors. Materials employed within healthcare must be durable enough to withstand harsh conditions, resistant to degradation, and, of course, compatible with the human body. Most materials are unable to tolerate medical environments; fortunately, the medical industry can rely on silicones for essential, life-saving devices and products.

 

Why the Medical Industry Uses Silicones

Silicones have long been a popular material for medical devices and medical device components due to their durability, ease of molding by many methods, wide temperature range, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, and compatibility with many sterilization methods. Furthermore, silicone is compatible with human tissue and body fluids, has a very low tissue response when implanted, and does not support bacteria growth – making it a perfect option for implants. 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.

Silicone has a unique molecular structure, namely its silicon-oxygen backbone, that results in several excellent properties. The following is a deeper dive into some of these properties, and why the medical industry uses silicones.

  • Superior Biocompatibility: medical devices and 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. Materials utilized in these applications are subject to rigorous and extensive biocompatibility testing and must comply with stringent regulations. Simply put, medical grade silicones are unmatched in their biocompatibility, making silicones an excellent option for the medical industry.
  • 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.
  • Chemical Resistance: silicones are resistant to water and many other chemicals. For example, LSR is chemically inert and its biocompatibility is unparalleled, making LSR a great option for medical devices, implantables, and other healthcare applications.
  • Ease of Processing: silicones utilized by the medical industry are easily processed via a variety of manufacturing methods. The 3 most common molding techniques are injection molding, transfer molding, and compression molding. Due to the high volumes required for many medical devices and products, injection molding is often the most cost-effective solution.
  • Conductivity: many materials degrade when exposed to electrical and other environmental stresses over time, however, this is not the case for silicones. Silicones are naturally nonconductive, and are often used in high-voltage and electrical equipment due to its electrical resistance and ability to act as an insulator. However, some medical applications require conductive silicone, which allows electric current to flow through the silicone product. Silicones are able to be formulated as necessary to meet the requisite conductivity demands.
  • 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.
  • Wide Temperature Range: compared to other materials, silicones, such as LSR, have excellent thermal stability. These 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.

 

ProMed Pharma’s Capabilities

ProMed Pharma is a leading contract manufacturer of polymer-based drug releasing molded dosage forms and combination device components, such as drug-eluting products. Working with both established and early-stage medical device and pharmaceutical companies, we develop robust manufacturing processes and platforms for extended drug release from a variety of materials, including silicones and thermoplastics.

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 – including Liquid Silicone Rubber (LSR) that is an excellent option for drug-eluting medical products! 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 have certified class 10,000 / ISO Class 7 cleanrooms.

Contact ProMed today at 763-331-3800 to discuss your next medical molding project.