Plastics can be adapted like no other material and are therefore of increasing significance for medical technology. Especially where disposable medical items are involved which are subject to maximum quality requirements on account of their use in or on patients, e.g. medical tubes, whereby this involves both the art of attributing the base material the right properties and sound knowledge of the entire production chain which is obliged to meet the manifold statutory requirements (Good Manufacturing Practice).
Different manufacturing processes are used: e.g. injection-molding, multi-component injection-molding and extrusion.
The extrusion process involves melting plastics or other viscous temperable materials in a continuous process and thereafter pressing it through a nozzle.
Extrusion technology products can be found in a variety of areas of application, e.g. construction, automobiles, aviation, furniture, cosmetics, foodstuffs and especially in medical technology.
Extrusion and co-extrusion processes are also used to manufacture single- or multi-lumen tubes for medical applications. Co-extrusion involves combining two or more materials in the extrusion head which cannot otherwise be blended or interfused. For example, it is possible to manufacture a tube whose internal material displays outstanding chemical resistance and whose outer material displays outstanding thermal properties. In principle, the range of possible polymers for use in co-extrusion is unlimited. But thermoplastic polyurethanes, polyamides, polyolefins and especially thermoplastic elastomers have proved ideal and can also be processed in micro-extrusion – an area of increasing significance in medical technology.
Because Medical technology is synonymous with very high functional demands - instruments must be extremely precise and often very robust - the injection-molding process is often used. This is a primary shaping process during which an injection-molding machine is used to plasticize the material in an injection unit which is then injected into an injection-molding tool.
Specially-developed "Medical Grade plastics" are applied for this process technology in the medical environment.
“Medical Grade” outlines a large profile of properties. On the one hand, it means tested bio-compatibility and physiological safety. Chemical and media resistance is yet another feature. Sterilizability on the part of materials is also a must in the medical environment.
Medical components are subject to the most stringent quality tests from the design phase through large-series production. There is no room for error. Multi-component injection-molding processes are used in these areas of application. The use of high-performance TPE compounds in multi-component injection-molding shortens the process time, reduces the fault rate and increases production reliability.
Multi-component injection-molding is defined as the sequential combination of several melts (plastics) during the injection-molding process. These processes are frequently used for attaching soft seals to hard components, e.g. technical medical sealing elements in syringes, pharmaceutical dosing systems or connections for catheter couplings.
The TPE recipes for the ProvaMed® portfolio offered by Actega DS are aligned toward extrusion and processing in injection-molding and multi-component injection-molding, and display very good adhesive properties in a wide range of plastics. Furthermore, the focus is on the lowest possible migration potential, bio-compatibility, protection against irritations of the mucous membranes, and freedom of PVC, phthalates, silicone and latex. And it goes without saying that our TPE can be sterilized – an indispensable prerequisite for technical medical applications. All recipes are developed specifically for the respective customer and subjected to complex testing in order to attain the requisite requirements on material properties which often range from very particular to extreme.