ATEVA MEDICAL EVA POLYMERS UNIQUE SOLUTIONS FOR YOU

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Eunice Simon
5 years ago
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1 ATEVA MEDICAL EVA POLYMERS UNIQUE SOLUTIONS FOR YOU

2 WHAT IS ATEVA MEDICAL? Ateva Medical EVA-based resins deliver the reliable performance required for medical applications. Celanese can help companies develop medical device products based on ethylene vinyl acetate (EVA) polymers. Celanese combines the unique properties of EVA polymers with high-touch service, in-depth technical expertise and comprehensive regulatory knowledge. WHY ATEVA MEDICAL? Medical device companies are facing more market challenges than ever. With competition from alternative technologies, continuous innovation is the key to retaining an edge over the competition. At Celanese, we use our market knowledge, applications expertise and manufacturing excellence to create unique solutions that deliver value to your business one customer at a time. Celanese has been providing EVA technology for select medical applications for years, and we re now building on our experience and proven technology to offer the benefits of EVA more widely for medical device applications. More than just polymers, the Ateva brand represents a commitment to each of our customers to help them realize their product objectives. Our technical support can assist you from proof of concept to commercialization, including regulatory support throughout the appropriate stages. We work closely with your technical and compliance teams to help them meet your performance targets in the prescribed timeframe and to conform with regulatory requirements. 2

APPLICATIONS Ateva Medical EVA resins may be considered for a variety of applications including: An EVA (CAS No.

Different grades of EVAs tend to have different ethylene-to-vinyl acetate monomer ratios and/or different melt indices

Anesthetic applications Medical bags (blood, total parenteral nutrition, ostomy) Dental applications Drug packaging Medical

medical device companies flexibility in product design.

3 APPLICATIONS Ateva Medical EVA resins may be considered for a variety of applications including: An EVA (CAS No ) copolymer has the following general chemical structure. Different grades of EVAs tend to have different ethylene-to-vinyl acetate monomer ratios and/or different melt indices (molecular weights). Anesthetic applications Medical bags (blood, total parenteral nutrition, ostomy) Dental applications Drug packaging Medical film Medical tubing and drainage Wound care n 3 m Because of their unique properties, Ateva Medical EVA polymers offer medical device companies flexibility in product design. They are biocompatible, stable and display excellent resistance to tissue growth. Moreover, they can be processed at low temperatures using a variety of manufacturing methods. EVA is optically transparent, offers good adhesion and flexibility, boasts excellent tear, puncture, impact and water resistance and is breathable and clinically accepted around the world. 3

4 PROCESS VERSATILITY Ateva Medical EVA resins are low-melting thermoplastics. They can be readily processed by melt mixing in conventional processing equipment such as extruders and injection molding machines. In addition, Ateva Medical EVA resins can be sterilized using conventional methods such as ethylene oxide and, for appropriate applications, gamma irradiation. Ateva Medical EVA resins can be processed up to a temperature of 210 C. Depending on the application, approved antioxidants may be added to enhance protection against processing degradation. Mixing Processes Melt mixing Extrusion Batch mixing Roll milling Weldability EVA offers excellent weldability Melt Processes Compression molding Injection molding Blow molding Vacuum forming Calendaring Extrusion Spinning Photo courtesy of Leistritz 4

ADVANTAGES OF ATEVA MEDICAL EVA GRADES Ateva Medical EVA resins are fully compliant with

testing for additional USP requirements.

been approved for use in numerous pharmaceutical and medical devices around the world.

products USP Class VI ISO biocompatibility Drug Master File (DMF) listed Oral toxicity FDA

5 ADVANTAGES OF ATEVA MEDICAL EVA GRADES Ateva Medical EVA resins are fully compliant with various international regulatory requirements for medical applications, including U.S. Pharmacopeia certification and others. Drug Master Files are available to be referenced by Celanese customers, and we offer testing for additional USP requirements. Widely accepted in medical applications including implanted products, EVA polymers have been approved for use in numerous pharmaceutical and medical devices around the world. Certifications, approvals and benefits may include but are not limited to: High purity products USP Class VI ISO biocompatibility Drug Master File (DMF) listed Oral toxicity FDA extraction test Food contact compliance (FDA and EU) Absence of heavy metals/pfoa/ halogenated substances REACH compliant Free from additives derived from animal origin GMO-free Phthalate-free Change management 5

SUPPORTING YOUR SUCCESS New medical devices can take years to develop, so designers and engineers must be sure that the polymers they select perform well, meet regulatory requirements and will be

6 SUPPORTING YOUR SUCCESS New medical devices can take years to develop, so designers and engineers must be sure that the polymers they select perform well, meet regulatory requirements and will be available long term. Celanese is committed to providing customers with: Celanese is focused on being your best supplier of EVA polymers. We use our market knowledge, our applications expertise and our manufacturing excellence to create unique solutions that deliver value to your business one customer at a time. Regulatory support throughout your development process Technical expertise Custom developmental grades possible Processing assistance Change notification and Quality Agreement support 6

7 ATEVA MEDICAL EVA GRADES SI Unit Test Method Ateva 1081G Ateva 1807EG Ateva 2803G RESIN PROPERTIES Vinyl Acetate % PTM Melt Index g/10 min. ASTM D Density Kg/m3 ASTM D1505 ASTM D Antioxidant No Yes No THERMAL PROPERTIES DSC Melt Temp C ASTM D Vicat Softening C ASTM D MECHANICAL PROPERTIES Tensile Break MPa Break % ASTM D638 Type IV (50 mm/min) ASTM D638 Type IV (50 mm/min) Hardness Shore A ASTM D Hardness Shore D ASTM D Flexural Modulus (1% Secant) MPa ASTM D CONFORMANCES USP Class VI Yes Yes Yes Drug Master File Yes Yes Yes STERILIZATION Ethylene Oxide Yes Yes Yes Steam No No No Gamma Radiation Yes Yes Yes 7

8 EVA POLYMERS celanese.com/eva-polymers ateva.com CELANESE EVA POLYMERS 222 W. Las Colinas Blvd. Suite 900N Irving, TX Celanese-EVA.com ATEVA.com CUSTOMER SERVICE t: e: MANUFACTURING Edmonton, Alberta Canada ATEVA.com TECHNOLOGY AND PRODUCT STEWARDSHIP 8040 Dixie Highway Florence, KY Celanese-EVA.com ATEVA.com Copyright 2013 Celanese or its affiliates. All rights reserved. This publication was printed on October 1, 2013, based on Celanese s present state of knowledge, and Celanese undertakes no obligation to update it. Because conditions of product use are outside Celanese s control, Celanese makes no warranties, express or implied, and assumes no liability in connection with any use of this information. Nothing herein is intended as a license to operate under or a recommendation to infringe any patents. 130-EVA 09/2013

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