MAXiTHEN medical. en ISO 13485:2012. Lasermarking for UDI. en ISO 22000:2005

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1 BRINGING LIFE TO PLASTICS MAXiTHEN medical en ISO 13485:2012 en ISO 22000:2005 Lasermarking for UDI

2 MASTERBATCH FOR MEDiCAL PRODUCTS

3 Colours according to DIN EN ISO 6009 PLASTiC, THE MEDiCAL MARVEL Cutting-edge medicine without plastics would be impossible today. It is the outstanding and flexible properties of plastics in particular that make this material so attractive and important for medical technology. Unlike glass, metal or ceramics, plastic scores with its ease of processing, fracture resistance, low weight and the possibility of designing it for specific requirement profiles. With the development of the MAXITHEN MEDICAL series, we have created a range of products for the medical technology sector characterised by the highest quality and offering low dosage and easy processing. Our expertise and market knowledge result from decades of experience in the medical field, thanks to which we are now in a position to meet almost all requirements in terms of colours and functional additives. CERTiFiED QUALiTY The requirements for products in the medical field are exceptionally high, which includes the consistently high quality of the raw materials. To meet these high requirements, we have the standards EN ISO 13485:2012 plus AC:2012 (Quality Management System for Medical Devices) and EN ISO 22000:2005 (Quality Management System for Food Safety). Thanks to our decades of experience in the production of masterbatch for medical products, we are amongst the market leaders in Europe in this segment. Our employees in Product Stewardship have extensive knowledge of product and raw materials and are familiar with country-specific regulations. The possibility of production at nine of our own locations in Europe gives our customers the guarantee of uninterrupted supply. Our Business Continuity Plan ensures maximum possible service levels are maintained and the risk of disruption is minimized. Business Continuity

4 highest Quality COLOUR MASTERBATCH Our MAXITHEN MEDICAL series consists of a range of colour masterbatch for almost all production technologies as well as a wide range of applications, including the colouring of needle holders according to EN ISO ADDiTiVE MASTERBATCH Laser marking Our laser additives allow non-contact, permanent marking or inscription of plastics. We provide a comprehensive service, from project idea to realisation. Our R&D has laser devices that are available for trials and testing to achieve the optimum marking quality. Four basic types of marking colours can be achieved: _ Dark laser marking _ Light laser marking _ Coloured laser marking _ Transparent laser marking The laser technology is particularly suitable for UDI (Unique Device Identification) established by FDA as the label is chemically resistant, sterilisation-resistant and approved for direct contact with food, and at the same time does not change the properties of the marked product.

5 Permanent Antistatic Our product increases the conductivity of the polymer and reduces the negative partially charged state. The addition of this masterbatch, also available in transparent form, ensures safe handling and precise dosing of powdered pharmaceutical materials. 2 Auto-Sterile Wherever people meet, germs spread which can have fatal consequences, especially in people with a weak immune system. Our active substance works on a physical basis and is permanently effective. Microorganisms are destroyed upon contact with the plastic surface, which prevents them from spreading. 3 X-ray Tracer For invasive procedures, the detectability of existing plastic items/products/objects is crucial. Plastic components are equipped so that they are recognisable by X-ray machines. 4 Lubricants Lubricants reduce friction between the individual plastic components. If the syringe plunger glides easily and smoothly into the cylinder, this is not only more comfortable for the patient but also allows greater dosing precision 5 Anti-Flame For the infrastructure of health facilities, we provide flame-retardant additives, which can of course be halogen-free if desired. Our flame-retardant masterbatches are designed in accordance with numerous international construction standards. 6 Protec For process and quality control in the manufacturing process, our product range includes the innovative additive Protec. Moreover, it can be used to protect against plagiarism, with the originality of the product being confirmed or rejected by means of a sensor. In the area of Self Dosing products, safety in dosing and the correctness of the material used can be ensured through the use of Protec.

6 BUSINESS UNITS OF GABRIEL-CHEMIE GROUP: Building & Agriculture Home & Lifestyle Packaging for Industrial & Consumer Goods Cosmetics Packaging 2017 GABRIEL-CHEMIE Gesellschaft m. b. H. - All images in this folder are symbolic photos for illustration purposes only, the final products shown are not necessarily produced with masterbatches of Gabriel-Chemie. Food & Beverage Packaging Medical GABRIEL-CHEMIE Gesellschaft m. b. H. Industriestraße Gumpoldskirchen Austria Tel Fax info@gabriel-chemie.com