SAMAPLAST develops high-quality plastic injection moulded parts, medical components and implants for the medical device industry.
Our solutions leave our site in St Margrethen, Switzerland, every day, and we are proud of our company history, which dates back more than 60 years.
Integrated solutions for medical device applications
SAMAPLAST’s ability to offer complete solutions is its strength. We oversee the development from the concept, through the prototype, to readiness for the market.
We develop technical injection-moulded parts, assemblies, medical devices and implants, as well as sterile packed end products.
Our medical devices are sought after in the dental industry and many other areas. For example, they are implemented for external fixations or instruments for multiple functions.
In addition to medical devices, Samaplast also manufactures highly diverse implants such as spinal vertebrae prostheses as disc replacements, elements for knee and hip implants or port catheters and many more.
Technical medical device engineering capabilities
Do you have new ideas for groundbreaking products? The engineering department at Samaplast implements such plans: together, we can develop your products quickly, flexibly and with the highest quality standards.
Idea, development and optimisation are empirically followed by market analysis and functional tests. Using our Stratasys or Kumovis 3D printer or the Arburg Freeformer, we manufacture prototypes and small series internally to enable you to quickly test your products on the market.
On request, we can also realise this from hardened steel tools within ten days. Whatever the issue, you can discuss it with us. We develop solutions for you
Specialised injection moulding
We process all thermoplastics, including polyether ether ketone (PEEK), polyetherketoneketone (PEKK), polyphenylsulfone (PPSU), polycarbonate urethanes (PCU), and polycarbonate (PC) and absorbable materials on our state-of-the-art qualified injection moulding machines.
The underlying principles are decades of experience, innovative power and precision and processes validated according to medical standards such as the Global Harmonization Task Force (GHTF). In addition, we produce plastic parts with a unit weight ranging from 0.01g to 1,000g. This is the basis for long-lasting, trusting customer relationships.
The market is increasingly demanding the production of small batch sizes for medical components and implants. Therefore, the machinery at Samaplast was further improved, including the addition of the Freeformer by Arburg and Kumovis PEEK 3D-printer. It can be used to produce generatively manufactured components with standard material or filament in cleanroom conditions, starting with a batch size of one.
Plastic injection-moulded component production
The production of plastic injection-moulded parts is only one part of SAMAPLAST’s portfolio.
In addition, we are specialists in their further processing (for example, laser marking, pad printing, ultrasonic welding, final packaging) and fully automatic manufacture under controlled conditions.
This ensures that our customers get high-quality, accurate products from a single source.
Highly equipped cleanrooms
Working in a cleanroom is essential at Samaplast. Clinically clean products are a necessity for many purposes. For this purpose, we have set up three cleanrooms (ISO 7 and 8 in operation according to EN ISO 14644) at Samaplast in which we manufacture these products and carry out finishing operations with the highest levels of quality and excellence.
We also use our Hamo-T21 ultra-pure water washing machine, which connects the dirty production area with the cleanroom via a sluice, to ensure purity.
In addition to our ultra-pure water washing machine, we possess a water-processing unit with which we prepare highly purified water (HPW) according to the European Pharmacopoeia.
Packaging and sterilisation services for safe medical devices
SAMAPLAST packages products in medical devices so that their application characteristics and capabilities do not change during the entire lifecycle. All packaging processes adhere to the requirements of EN ISO 11607.
We document the process of final packaging and produce proof that the specific requirements regarding sterility and functionality of the packaged medical device are fulfilled until the point of use. We are also happy to undertake safe packing in protective packaging
In addition to final packaging, we provide sterilisation of the medical devices with gamma radiation according to EN ISO 11137 or ETO according to EN ISO 11135, including validation and final approval, in cooperation with our partners. This way, we guarantee the Samaplast quality you are accustomed to.
About SAMAPLAST AG
SAMAPLAST was founded in 1960 in St Margrethen. As a contract manufacturer, we develop and produce customer-specific products and services for various branches of the industry. More than 80 employees combine long-term know-how in injection moulding with innovative solutions to ensure our customers’ success.
SAMAPLAST is certified EN ISO 13485 / 9001 and DIN SPEC 17071, as well as registered with the US Federal Drug Administration (FDA). We are also accreditated by Brazil’s National Sanitary Surveillance Agency (ANVISA) and the Japanese Pharmaceutical Affairs Law. (JPAL) .
SAMAPLAST AG was certified in accordance with DIN SPEC 17071 in November 2020, so can implement customer projects from idea to printed prototype or medical product / implant under controlled and certified conditions.