Processes & Quality
Siltec is certified in accordance with ISO 9001:2015 and ISO 13485:2016. Thus, processes meet strict requirements and documentation obligations. This applies for the entire value-creation chain and includes Purchasing, Sales, Production, Quality Assurance, and Shipping/Logistics.
The materials used by Siltec meet the stringent requirements of specialized industries. Siltec offers materials that correspond to conventional pharmacopeia, such as USP Class VI and EP 3.1.9. In addition, parts of ISO 10993 can be fulfilled, e.g. regarding cytotoxicity. To meet food safety standards, Siltec offers products in accordance with provisions of FDA §177.2600, BfR XV, and Directive (EC) 1935/2004. Aviation-specific conformities, e.g. parts of 14 CFR/CS 25.853 or AITM 3.0005 can be met. In the field of medical technology, some products fulfill EC Directive 93/42/EWG, Appendix II without section (4). This produces requirements for raw material, which can only be met by select suppliers.
Production processes and provisions are strictly secured to minimize, for example, bacterial contamination. This also includes inspection and packaging in a controlled environment.
Siltec extrudes tubes, strings, and profiles in continuous lengths on modern extruders. In doing so, multiple raw materials can be used, e.g. X-ray contrast mediums. They are chopped into pieces or processes into rings upon request. Molded parts can be manufactured either using the injection molding or compression molding process. Silicone parts can then be bonded through cold or hot vulcanization. Products are further processed in the manufacturing department. This includes the printing, vulcanization, talcum powder treatment or surface treatment of products. Siltec provides punching or water jet cutting services of products for sheets (and other products). The stringent requirements of our quality processes mirror the expectations of our customers. Many products, such as heated breathing tubes, undergo an additional detailed individual inspection.