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Silicone 101

Silicone is chemically known as polydimethylsiloxane (PDMS) and consists of an Si-O-Si backbone. The Si-O bond has higher bond strength than the C-C bond found in carbon-based polymers, such as polyethylene and polypropylene. As a result, silicone can withstand higher temperatures. It also doesn’t absorb as much energy at the wavelengths typically found in UV as well as gamma irradiation, so it is weathers well and is well suited for medical applications that require gamma sterilization. It is also considered to be very chemically inert. Its Si-O-Si bond has wide angle and little energy is needed to rotate, so silicone polymers are very flexible even at low temperature such as -50°C.

Silicone elastomers are typically filled with inorganic fillers, such as silica or carbon black, to enhance the mechanical properties as well as reduce some costs. Silicone can be cured by addition chemistry (eg. Platinum catalyst), free radical (Peroxide cured system) or condensation cure. Since it was first commercialization in 1940s silicone has found a number of applications in medical devices, implants, biopharmaceutical manufacturing, transportation, aerospace, construction, electronics, as well as other industries due to its performance.

  • Silicone is a thermoset material: there are a few key benefits to this. It won’t melt, so it has strength at higher temperatures. It also won’t dissolve in solvents, instead it will swell, so it has fairly good chemical resistance. The crosslink network gives it very good elongation properties.
  • Silicone is inert: This makes it a biocompatible material that is well suited to meet USP Class VI and ISO 10993 requirements, and has a long history in medical applications.
  • Silicone has a low surface energy: Used in many applications to repel liquids and to release easily, it may be challenging if required to bond to another material. Attaching silicone to other materials may require a look at insert/overmolding or 2-shot molding to make it work in your device.
  • Silicone is highly elastic: Elasticity allows silicone to retain its shape after deformation, which makes it an ideal material in dynamic applications such as enteral feeding or drug delivery pumps. To modify this property to suit your application, you may want to look at a custom compound.
  • Silicone is easily formulated to meet specific properties: Such as permeation properties, physical properties, even clarity. Understanding the overall limitation is key to properly formulating silicone, but playing with thing like crosslink density, filler content and loading, and other key parameters opens up a world of possibilities to engineering a unique solution.
  • Sterilization of Silicone: Silicone withstands sterilization methods including autoclave, gamma radiation and ethylene oxide.
  • Silicone durometers: Silicone is available in a wide range of durometers – 0 Shore A to 80 Shore A.

About Saint-Gobain

Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in so many industrial applications.

 

Saint-Gobain Performance Plastics' group of businesses gather solutions to save energy, provide protection, improve comfort and sustain the environment for a variety of markets.

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Saint-Gobain’s medical products are distributed exclusively to medical device manufacturers for use in the manufacture, assembly or distribution of their medical devices. Saint-Gobain cannot authorize the sale of its medical products directly to device user facilities (e.g. hospitals, surgery centers, nursing home, clinics, etc.), nor directly to end users (e.g. patients, patients’ caregiver, prescribing physician, nurse, pharmacist, etc.), including distributors serving device user facilities and end users directly. In accordance with every jurisdiction globally, Saint-Gobain’s customers are responsible for determining that any medical device they manufacture and market that incorporates a Saint-Gobain’s medical product, is compliant with each country-specific medical device regulations and has received proper country-specific clearance, certification or registration authorizing the sale of this medical device.


Saint-Gobain’s medical products offer covers:
- Medical Components [21 CFR 820.3(c)], intended for processing or use in the manufacture or assembly of medical devices before the finished medical device is packaged/labeled; Medical Components are intended to be included as part of the finished, packaged, and labeled device [21CFR820.3(c)].
- Finished Devices [21CFR820.3(l)] made on behalf of medical device manufacturers [21 CFR 807.20(a)(2)] under contract-manufacturing agreement. In accordance with the United States’ jurisdiction, Saint-Gobain complies with the FDA’s requirements for contract manufacturers of finished devices.

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