For applications in the field of medical technology, Siltec manufactures silicone components that are specifically designed to meet the needs of a sensitive industry. Siltec offers materials that comply with conventional pharmacopeia, such as USP Class VI and EP 3.1.9, as well as conformities, e.g. FDA §177.2600. In addition, parts of ISO 10993 can be fulfilled, e.g. cytotoxicity. The materials can be sterilized using different methods, for example, by means of steam sterilization at 134°C.
Siltec manufactures molded parts from liquid silicone rubber (LSR) and from high-temperature vulcanizing (HTV) silicone rubber, as well as extruded products, such as tubes for intensive care and laboratories. Through in-house compounding, a variety of colors, hardness levels, and additional material properties can be offered specific to the needs of the customer. Our flexible equipment portfolio enables the manufacturing of intricate micro-components as well as material-intensive components and parts with large dimensions. Siltec offers to inspect and package the manufactured components in a controlled environment.
Siltec’s production officially complies with the ISO 13485 standard. The standard confirms that Siltec runs a comprehensive quality management system required for the design and manufacture of medical devices. In addition, Siltec is registered as a contract manufacturer with the FDA in the USA. By agreement, Siltec can thus produce silicone molded parts, silicone tubes or silicone seals in accordance with the requirements of the FDA 21 CFR 820 standard.
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