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Fabrication of Sterile End Products

Fabrication of Sterile End Products

03/10/2011
SAMAPLAST AG

From idea to marketability, SAMAPLAST AG manufactures medical implants for the knee, the hip or the spine on the highest clean room conditions (ISO class 7 “in operation” according to ISO 14644) using plastic injection-molding procedures. The supplemental product program ranges from instruments to dental parts and as far as catheter hubs. For this purpose manages SAMAPLAST AG a quality-management system certified to ISO 9001:2008 and ISO 13485:2003.

With this focus, the enterprise domiciled in St. Margrethen, Switzerland, processes thermoplastics, such as PEEK, PSU, PEI, PPS, TPE, PC and POM, into plastic parts. In addition to the injection molding production, preceding and subsequent processes, such as final rinsing with HP water, laser marking, ultrasonic sealing, tempering, final packaging and sterilization with gamma or ETO complete the service offering.

A current example of the service offering of SAMAPLAST AG is the fabrication of an implant for Synthes GmbH. In the development phase already, SAMAPLAST AG was free to bring in the injection-molding part geometry in the design development. It was a particular challenge to coordinate the product requirements and the possibilities of the injection-molding fabrication in such a way as to generate a successful product. For the fabrication of the implant, we employ the final rinsing of a chromium-steel needle, the injection molding with the insert molding technology, laser marking, low-germ primary and secondary packaging, packed in customer-specific product boxes and gamma sterilization. We implemented the validation of the specified processes allowing for the respective standards, such as ISTA 2A, ISO 11607, ISO 11137 etc., and documented product-specifically. The prerequisite for this are qualified operating facilities, which SAMAPLAST AG uses for the manufacture of implants, as well as product testing procedures validated by a Measuring System Analysis MSA.

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