Health & Baby Care
Health is a high priority in our lives. That’s why the requirements for materials used to promote healing, support the body or even replace body parts are very stringent. High-purity silicones fulfill these requirements, which makes them indispensable in medicine. Their exceptional properties make them ideal for highly sensitive health care and baby care applications.
In the field of health care, WACKER’s ELASTOSIL® and SILPURAN® brands offer both solid and liquid silicone rubbers (HTV and LSR), as well as room-temperature-vulcanizing (RTV) silicone rubber and silicone gels.
- SILPURAN® silicone elastomers and adhesive gels contain only precisely-defined ingredients, such as siloxanes, silica and crosslinkers/catalysts. In addition, they do not contain phthalates or other organic plasticizers, latex, plant proteins, organic stabilizers or materials of animal origin. This minimizes potential allergic reactions.
- Our SILPURAN® silicone elastomers and silicone gels have successfully undergone sensitization tests according to ISO 10993 and show no adverse effects on the skin.
- Silicones are usually easy to sterilize. A number of methods are available, such as sterilization with steam, electron beams and γ-rays or ethylene oxide, all of which – with very slight variations – yield the same properties. Ideally, these processes do not influence the product properties.
- Silicone gels are the exception since they cannot be sterilized with electron beams and γ-rays.
- Our SILPURAN® silicone elastomers and silicone adhesive gels were successfully tested for biocompatibility using selected USP Class VI and ISO 10993 tests. (ISO 10993: cytotoxicity, sensitization, pyrogenicity; USP<88>: systemic toxicity, intracutaneous toxicity, and implantation for five days).
- FDA-listed medical device master files (MAFs) are available for many products to simplify registration.
