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SAMAPLAST AG – A success story
For over 60 years, SAMAPLAST has been producing sterile, final-packaged medical devices for international customers under the highest cleanroom conditions using the plastic injection molding process.
The product range ranges from dental parts and catheter connections to long-term implants (PEEK cages) and resorbable implants.
SAMAPLAST is certified according to EN ISO 13485 and ISO/ASTM 52920 certified and registered by FDA, ANVISA and JPAL.
SAMAPLAST, based in St. Margrethen (CH), processes thermoplastics such as PEEK, PSU, PEI, PPS, TPE, PC, POM, ABS, PP, PE and polylactides into plastic parts.
Validated processes such as final rinsing with HPW water, laser marking, ultrasonic welding, gluing, final packaging and sterilization with gamma, X-Ray or ETO are the range of services.
To check the quality of parts, in-house multi-sensor 3D measuring machines and a CT, among others, are available.
Since 2018, SAMAPLAST has been producing prototypes and medical devices (e.g. made from PCU, polylactide) in AM using Arburg Freeformer or PEEK printer in clean room ISO 8 (in operation) and in a certified environment according to ISO/ASTM 52920.
SAMAPLAST AG - Your partner from the idea to the finished assembly or sterile final packaged medical product/implant.
Implemented projects with customers :
• Parts, packaging systems and equipment for the dental industry
• Parts, packaging systems and equipment for ophthalmic surgery
• Spinal vertebrae prostheses
• Meniscus prosthesis
• Components for hearing implants
• Port Catheter
• Sternum-Closure
• Cardiac catheter
• Sports Medicine Implants for the School Uterus (PEEK and Resomer Screws and Anchors)
• Resomer implants and the corresponding instruments for vein closure
- Components for hearing aids
Our services for you:
• Development support according to MDR
• Samples, prototypes or small series on request in 10 days made of hardened steel
• GMP compliant mold making
• Many years of know-how in injection molding
• Cleanroom production (ISO class 7 in operation)
• GMP-compliant follow-up processes, US welding, laser marking, pad printing, gluing, soldering, component assembly…
• Sterile final packaging (ISO 11607)
• Sterilization responsibility (ISO 11137….)
• Additive manufacturing under ISO class 8
