Within the medical industry, mechanical performance, chemical resistance and low contamination levels are critical for successful production. Seals play a vital role in a wide range of pharmaceutical equipment, analytical apparatus and medical devices, used where fluids and gases are contained or transferred.
Novotema can mould elastomer seals and components in infinite shapes and sizes to suit any medical application. We are certified to ISO 13485:2012 quality management system for the design and manufacture of gaskets and various technical rubber articles, moulds and compounds, for the medical device industry.
High performance elastomer materials
Novotema provides an extensive range of materials to suit any medical application, including high performance elastomers which are able to withstand a wide range of process media, potent active pharmaceutical ingredients (API's) and aggressive cleaning regimes used to clean pipework and vessels.
Full batch traceability is maintained throughout the manufacturing process and the issuing of BS EN ISO 10204 certification available. Materials are certified and compliant with industry standards such as FDA and USP Class VI (United States Pharmacopeia).
How Novotema can help your medical engineering application
When selecting a medical grade sealing solution Novotema understands that various factors must be considered, including hardware specifications, process media, temperature, motion, pressure or vacuum and seal life expectations. Our engineers offer additional services to ensure you receive the most effective sealing solution:
- Support and consultancy on elastomer material selection, products and manufacturing
- Custom component design for complex applications and component requirements
- Laboratory testing and FEA simulation to test components in their real-life environments
How can we help? Contact us to discuss your medical equipment sealing requirements with our experts, or chat to us online.
Products for medical applications
Below is a selection of the most common products we supply to the medical industry. Visit the Products page to see the full range.
Fully customised solution that meets your application requirements precisely. Our experienced team of engineers are the experts when it comes to designing the right seal for maximum performance and efficiency.
Membranes / Diaphragms
Novotema specialises in moulding high quality diaphragms and membranes with very thin cross sections, to tight tolerances, in infinite sizes, shapes and custom configurations.
High quality, precision O-rings in quantities from 5000 up to millions; available in standard sizes or custom sizes from 1mm to 450mm internal diameter and 0.6mm to 12mm cross section.
Gaskets / Frame Seals
Gasket / frame seals fill the space between two or more mating surfaces, they can be moulded in infinite shapes and profiles to suit any geometry and application.
Elastomer materials for Medical applications
|Material Code||Hardness||Operating Temperature||Colour||Approvals / Certification|
|EPDM||53 - 75 IRHD||-40 to 150°C||White, black||FDA, USP|
|FFKM||71 - 75 IRHD||-46 to 310°C||White, black, transparent||FDA, USP|
|FKM||70 - 75 IRHD||-20 to 200°C||White, black||FDA, USP|
|VMQ||60 - 78 IRHD||-60 to 250°C||White, black, transparent||FDA, USP, metal detectable|
ISO Class 6 (FS 209E Class 1,000) cleanroom for the manufacture of elastomer components medical and pharmaceutical equipment and other applications requiring a high standard of cleanliness.Find Out More
Novotema moulds seals and components from a wide range of elastomer materials. With an extensive range to choose from, there is sure to be a material to suit every application. Browse the range ....Find Out More
Research and development, testing and analysis of polymer materials to ensure final components meet customer specifications and requirements.Find Out More
Novotema operates from an 8400 sq.m. manufacturing facility using a combination of injection moulding and compression technology to manufacture over 850 million parts a year.Find Out More
Surface treatments can be applied to moulded components which enhance their operating characteristics and performance.Find Out More