Custom-made seals for the pharmaceutical industry
Sealution supplies custom-made rubber seals made of EPDM, silicone and liquid silicone for various medical applications. These include respiratory therapy, orthopedic drainage, extracorporeal blood circulation, dialysis and clinical nutrition. All components are produced in certified clean rooms, following the guidelines of the European standard for medical devices (ISO 13485:2016).
Years of experience with rubber seals
Sealution has more than ten years of experience in the field of Liquid Injection Molding. In addition, we continue to work on the further improvement of our product quality. Our clean room enables us to produce high quality rubber seals, especially when it comes to medical and baby products.
Curious about which products Sealution supplies?
What standards do Sealution rubber seals meet?
For components and equipment used in the food, pharmaceutical and medical industries, standards and regulations apply to ensure the health and safety of human beings. The rubber seals from Sealution comply with the following standards:
- ISO 9001
- IATF 16949
- ISO 13485
- ISO 14001
- British Standard BS 6920
- Food and Drug Administration (FDA)
- LFGB (Lebensmittel- und Futtermittelgesetzbuch)
- RoHS (Restriction of Hazardous Substances)
- REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)
- Requirements for PAHs (polycyclic aromatic hydrocarbons)
Our seals are produced in a clean room
Medical parts are produced in a dedicated area: our certified clean room. This is a completely clean space where the air is filtered to remove dust particles, microbes in the air, chemical vapors and other impurities that can contaminate the product.
Need large volumes? No problem!
For the production of large volumes of rubber seals, Sealution uses an automated production system. This applies under the following conditions:
- High product demand (requiring high productivity)
- Stable product design
- The product has a longer lifespan (in most cases the lifespan of the product is at least a few years)
Automated production lines have a number of advantages:
- A lower labour share
- Lower product costs
- Higher productivity
Special production process for sanitary requirements
A special form of production is the overmolding process. Materials, such as plastic or metal, are combined with a silicone part in one production process. This saves on assembly costs. In addition, the combined part better meets sanitary requirements.
We use materials from well-known suppliers such as Wacker, Dow Corning, Momentive, Lanxess and others.