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Extrusion Moulding Assembly Multilayer Tubing No other subject is as multilayered as this RAUMEDIC – Expertise in tubing RAUMEDIC Coextrusion Our health is one of our greatest goods. Promoting and maintaining is the highest quality principle that we as partners of the medical technology and pharmaceutical industries have committed to our customers and to all patients. RAUMEDIC has a broad range of manufacturing capabilities ÆÆ Light protection and drug compatibility ÆÆ Bag connectors ÆÆ Pressure resistance ÆÆ Compounding ÆÆ Micro coextrusion ÆÆ Prototyping ÆÆ Extrusion ÆÆ Injection Moulding ÆÆ Assembly Multilayer tubing provides a modern, effective, and commonly used solution for a wide range of applications in medicine, especially if the requirements and production methods of a medical system require the use of several materials. We apply over 60 years of experience in the development and manufacturing of high-quality plastic components ÆÆ Up to four layers can be combined, depending on material requirements for medical use to every single one of our products, from in-house material formulation and compounding, to ÆÆ Variable layer thickness distribution based on economics and technical application individualised production of various tubing configurations and moulded parts for each customer, and to finished ÆÆ Special consideration for compatibility within the body and with the flow-through medium or medication system products. ÆÆ Integration of active layers, such as for light protection properties ÆÆ Embedding of multiple colour and X-ray contrast stripes RAUMEDIC Quality management Variable material combinations Customer satisfaction is at the centre of our quality concept. Compliance with all regulatory requirements is Homopolymers, copolymers or polymer blends are For example: fundamental to RAUMEDIC's principles. primarily used in the production of tubing. In cases ÆÆ Polyethylene (PE) in which the inner side of the tubing must display ÆÆ ISO 13485 ÆÆ ISO 9001 ÆÆ Clean room in accordance with ISO 14644, Class 7 ÆÆ GMP standards ÆÆ CE-certification 2 characteristics different from those of the exterior, a special formulation alone no longer suffices. Hence, we have developed various combinatory possibilities that allow us to extrude tubing with up to four layers out of different materials depending upon the requirements and compatibility of materials. ÆÆ Polypropylene (PP) ÆÆ Polyvinyl chloride (PVC) ÆÆ Ethylene vinyl acetate (EVA) ÆÆ Polyurethane (PU) ÆÆ Polyamide (PA) ÆÆ Thermoplastic elastomer (TPE) 3 RAUMEDIC Light protection and drug compatibility RAUSORB – for light-sensitive solutions RAUINERT – for loss-free dosage of sensitive drugs RAUSONERT – loss-free dosage of light-sensitive solutions In the therapeutical field, there is an increasing use of Low dosing speeds for modern active agents means Light-sensitive preparations in low dosage make high light sensitive pharmaceuticals which can lose activity longer dwell times in the hose system, which increases demands on transport tubing. by light exposure. the risk of undesired interactions between the medication and the tubing. RAUMEDIC RAUSORB tubing RAUMEDIC RAUINERT tubing RAUMEDIC RAUSONERT tubing ÆÆ Physiologically harmless inner layer ÆÆ No loss of active agent through adsorption ÆÆ Absorption of the desired wavelength range by ÆÆ Outer material layer with filtering effect ÆÆ No migration of components of the tubing ÆÆ Colouration of the outer layer matched to the activation spectrum of the product being infused (wavelength range 200 - 450 nm) formulation ÆÆ Formulation and dimensions designed for specific medications ÆÆ Transparent colouration allows any contaminants ÆÆ Tubing remains transparent ÆÆ No loss of active agent due to inert formulation of inner tubing ÆÆ RAUSONERT tubing combines the advantages of or disruptions to be detected easily RAUSORB and RAUINERT ÆÆ Individual design of dimensions, hardness, colour, ÆÆ Dimensions, formulations, and tubing construction and formulation to meet specific requirements 4 coloured outer jacket designed to suit medications and processing Example: Example: Example: Antihypertensive Nitroglycerine, insulin Cytostatics 5 RAUMEDIC Bag connector Filling tube for welding into film bags Extrusion of tubing in the smallest sizes A combination of up to three polymers formulated The miniaturisation of tubing products is a result of the in-house allows targeted coordination with manual or prevailing trend in medical technology towards the use of automated assembly processes in post-processing. ever smaller products to enhance patient experience. Not RAUMEDIC Micro coextrusion only so-called minimally invasive surgery naturally demands ÆÆ Secure bonding of pressed-in connectors made of various materials, such as PC and PP catheter products that are smaller and more challenging to use, but diagnostics as well use increasingly miniaturised ÆÆ Optimal weldability with all typical film grades tubing due to ever smaller sample quantities. ÆÆ Processible on different machine types With its special micro extrusion facilities, RAUMEDIC can also ÆÆ No delamination of individual layers produce multilayer tubing with up to four different materials, ÆÆ Low risk of particle abrasion with the smallest attainable inner diameter of around ÆÆ Machine stability at high processing speeds 0.1 mm and wall thickness in order of 0.05 mm possible. ÆÆ Dimensions and material formulations according to customer specific requirements Application examples: RAUMEDIC Pressure resistance Coextruded high-pressure tubing Especially for high-pressure applications, RAUMEDIC has developed an optimal alternative to (monofilament) reinforced tubing using a coextrusion process. The result is a perfect compromise between 2 Layers 3 Layers 4 Layers Application: Insulin therapy Application: Percutaneous transluminal coronary angioplasty (PTCA) Application: Regional anesthetic ÆÆ Excellent insulin compatibility ÆÆ Good weldability (PA) ÆÆ High rigidity for adequate pressure resistance and flexibility. ÆÆ Burst pressure: up to 1,200 psi (83 bar) ÆÆ Good transparency due to lack of reinforcement ÆÆ Very good adhesion for further processing ÆÆ Customer-specific dimensions and layer distribution upon request (LDPE) ÆÆ Transparency, flexibility, adhesion (PUR) ÆÆ Low friction and wear-resistant behavior (PE) ÆÆ Bonding of both layers with an adhesive (layer thickness approx. 0.005 mm) insertability and kink resistance when placing the catheter (PA) ÆÆ Low absorption of local anesthesia (PA) ÆÆ High flexibility after application is complete (PUR) 6 7 Have we captured your interest? Our development specialists can assist with any questions about manufacturing tubing and plastic components for use in medical technology or pharmaceuticals. Our goal is to provide customised, individual solutions at the highest quality level for your product requirements, in order to be able to solve even very complex challenges together. We will be happy to inform you about other aspects of our tubing program, including multilumen technologies, tubing reinforcement, 11.2011 09.2013 -– Copyright Copyrightby byRAUMEDIC RAUMEDICAG AG - Design: medienimpuls.com C83700 C22700 RAUMEDIC AG Hermann-Staudinger-Str. 2 95233 Helmbrechts GERMANY Phone: + 49 (0) 92 52 359-0 Fax: + 49 (0) 92 52 359-1000 [email protected] www.RAUMEDIC.com Quellen: S. 3: © Tyler Olson - Fotolia.com or film tubing extrusion.