Silicone for Medical Technology
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.
For further information on our silicone tubes, silicone breathing tubes or seals for medical technology please click here:
Assembly & complex parts
Various products in the medical technology sector require assembly or other manufacturing processes such as cleanroom packaging or cleanroom production. This may involve products such as silicone tubing systems, tubing sets, catheters, components with integrated electronic components or complete assemblies. In addition, a variety of products require the combination of silicone parts with plastic parts. Siltec handles a variety of these processes for customers and offers an extremely broad and comprehensive manufacturing spectrum for medical technology.
Intensive Care and Consumables
Respiratory masks or breathing tubes for intensive care as well as tubes and tracheostomy tubes for long-term respiratory assistance are constantly in contact with patients. Therefore, they must have particularly good physiological properties.
Siltec reliably implements specific requirements, such as the use of X-ray contrast medium or the manufacturing of components with different properties in the 2K process.
Diverse packaging options, such as individual packaging or packaging under controlled conditions, are available for intensive care and consumables.
Laboratory and Sterilization Accessories
Laboratory and sterilization accessories are often subjected to sustained loads due to heat and pressure. The ability to disinfect and sterilize them as well as their high chemical resistance are among the core requirements. Siltec provides elements, such as seals for sterile containers or tray systems for mechanical instrument preparation. Our portfolio also includes packaged sealing systems for tabletop devices or large devices that are used in the central sterile supply department (CSSD).
Surgical Devices and Accessories
Due to its structural purity, silicone rubber is ideally suited for use in the operating room. Silicone components for surgical devices and accessories include sterile sealing systems or seals for surgical devices, monitors or operating panels. Siltec manufactures accessories based on customer specifications for numerous areas of medicine, such as neonatology, pediatrics or adult care. Complex requirements are also reliably met based on our many years of experience.
Silicone products with FDA registration
Siltec production meets important standards required for the manufacture of medical devices. For many years, the company has complied with the ISO 13485 standard, providing quality management for the production of silicone parts for medical technology. In addition, Siltec can – by agreement – register as a contract manufacturer of a medical device with the U.S. Food and Drug Administration – the FDA. This allows Siltec to manufacture silicone medical tubes, silicone molded parts, or silicone seals for medical device companies who wish to distribute these silicone products in the United States.
Baby Care Articles
Silicone products that are used for babies must meet particularly high requirements. Molded silicone parts are used in drinking bottles, such as bottle nipples, soothers, and pacifiers. For milk pumps, Siltec products are used as valves, tubes and tube systems, as well as seals and duckbills. Siltec offers materials that comply with the food industry in accordance with FDA §177.2600, BfR XV and Directive (EC) 1935/2004, as well as biocompatibility in accordance with parts of ISO 10993 (e.g. cytotoxicity).