Precision injection moulding

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1 Extrusion Moulding Assembly Precision injection moulding Customised polymer solutions

2 Your development partner and system supplier for medical and pharmaceutical assemblies and systems CERTIFICATE The Certification Body of TÜV SÜD Management Service GmbH certifies that RAUMEDIC Quality management RAUMEDIC AG Hermann-Staudinger Str Helmbrechts, Germany including the sites and scope of application see enclosure RAUMEDIC offers a variety of production options for sophisticated and innovative customer requirements: Compounding Prototyping Injection moulding Extrusion Assembly has established and applies a Quality Management System. An audit was performed, Report No Proof has been furnished that the requirements according to ISO 9001:2008 are fulfilled. The certificate is valid until Certificate Registration No TMS Munich, Page 1 of 2 QMS-TGA-ZM ISO ÆISO Æ 9001 Appendix II to EC directive 93/42/EEC Appendix II to EC directive 90/385/EEC Clean room production in accordance with ISO 14644, ISO class 7 (= 10,000) GMP standards CE-certification RAUMEDIC Material competence RAUMEDIC Your specialist for customised injection moulding solutions Precision injection moulding Silicone moulding Multi-component moulding Insert- and Overmoulding ÆAssembly Æ RAUMEDIC processes all thermoplastics including high temperature materials as well as silicone. 2 3

3 Research and development RAUMEDIC conducts continuous research on new materials, formulations and products. Research and development activities are conducted in our in-house laboratories. RAUMEDIC continually searches for new innovations in polymer products using new or modified materials with improved or additional functional properties. RAUMEDIC Design Individual products demand differentiated approaches. Depending on the requirements, optimum function of the products follows intuitive and ergonomic handling as well as customised appearance and feel. To achieve this we consider best design for manufacture and most economic manufacturing methods. Meeting your requirements is a pleasure for our experienced design engineers and product designers. Our Interfaces: RAUMEDIC researches for innovative products: e3 / e2 stp / step igs / iges Basic research dxf / dwg Product development Process development Collaboration with universities and institutions RAUMEDIC has extensive knowledge in these areas: RAUMEDIC Prototyping It is often a long way from the initial idea to the finished product for serial production. The use of an effective prototyping is helpful in saving costs and time. With prototyping, RAUMEDIC offers the option Dehesive surfaces of creating samples and small-scale series quickly and Barrier functions economically. Antimicrobial properties Anti-counterfeiting Hygroscopic polymers Alternative materials There are numerous options for: Stereolithography Laser sintering Vacuum casting 3D printing Prototype tools 4 5

4 Precision injection moulding Smallest dimensions, tightest tolerances and highest functional demands are customer requirements which RAUMEDIC fulfils in precision injection moulding. We develop and produce customised moulded parts with component weights from g to 200 g. We produce high-precision injection moulded parts under clean room conditions using modern machinery. Our production processes are developed and validated by the use of suitable statistical processes. Cannula holder for pre-filled syringes Application system for liquid drugs Moulded-on catheter head for insulin applications Handset for laser operations 6 7

5 Silicone moulding RAUMEDIC develops and produces single and multicomponent solutions to highest demands. Our silicone specialists develop customised product solutions from the initial idea to series production. Features and benefits Platinum and peroxide silicone systems Long-term implantable All sterilisation types Extremely long storage stability Good elastic and mechanical properties, resistant to deformation Complex shapes Thin walled designs down to 0.2 mm Component weights from 0.03 g to 100 g Multi-component technology in hard-soft or soft-soft Overmoulding Surface modification 8 9

6 Multi-component moulding The multi-component technology offers the ideal planning requirements for the development of new, innovative, medical and pharmaceutical products. With this technology, RAUMEDIC produces moulded parts in thermoplastic polymers and silicone. A large number of polymer materials can be combined and processed using the multi-component technology. This technology offers the possibility of combining various product features with low cost assembly. Catheter coupling for regional anesthetics Features and benefits Combination of various materials, hardness grades and colours Elimination of cost and time effective assembly Integration of several functions into one component Optimal coordination of individual components Sandwich moulding Assemblies with barrier function Luer cannula for eye surgery Drug container with barrier function 10 11

7 Insert- and Overmoulding RAUMEDIC has expertise in extrusion and injection moulding as well as overmoulding. Overmoulding includes fully-automated moulding processes with tubing and metal components. Overmoulding materials that are impossible to be glued together provide connections with greater tensile strength and better pressure tightness. Luer cannula for eye surgery Overmoulded connector to a PVC tube for inhaler applications Ruler guide for meniscus surgeries Features and benefits Manual, semi- and fully-automated handling of insert parts in the injection moulding process Optimal connection of individual components High seal requirements Automation Customised testing and inspection processes RAUMEDIC assembly responsibility 12 13

8 Assembly The diverse assembly repertoire of RAUMEDIC combines tubing and components into customised systems in sterile packaging. Extrusion, injection moulding, assembly all from one source! RAUMEDIC assembles moulded parts with in-house extruded tubing via manual, semi- or fully-automated assembly. Fully-automated assembly Features and benefits Punching Printing Tip forming Thermoforming Microchip technology Integration of electronic components Fully-automated UV-curing Packaging Sterilising Certifying 100% camera control 14 15

9 Service worldwide! Let RAUMEDIC be your development partner! Thanks to our global sales network we can service and advise our worldwide customers individually and locally. C C Copyright Copyrightby byraumedic RAUMEDICAG AG RAUMEDIC AG Hermann-Staudinger-Str Helmbrechts Germany Tel.: + 49 (0) Fax: + 49 (0)

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