Materials. Powering Ideas.

Transcription

1 Materials. Powering Ideas. Europe ISO 13485:2016 * High Performance Medical Grade Resins for Single- & Multiple-Use Devices and Equipment Housings *Trinseo s medical manufacturing facilities and related global functions are ISO certified with the latest 2016 version that places a greater emphasis on risk management and process validation.

2 Trinseo Medical Application Policy Trinseo produces medical grade resins under stringent quality guidelines and controlled conditions. We strive to understand our customers needs and expectations regarding patient safety, reliability, and compliance with regulatory requirements, and to provide biocompatible resins according to ISO standards. Additionally, Trinseo medical grade resins are subject to management of change and formula lock that involve notifying customers of an upcoming change followed by locking that formula for an extended period of time. Based on Trinseo s interest in collaborating with its customers, Trinseo has developed an internal process for reviewing customer requests for use of ISO certified materials in certain medical applications. Through this review process, we determine whether or not Trinseo will support the use of Trinseo materials in the proposed medical application based on 1.) Device Category, 2.) Type of Body Contact, and 3.) Duration of Body Contact utilizing the ISO :2009 guidelines, Biological Evaluation of Medical Devices Part 1: Evaluation & Testing. As part of the Trinseo review process, Trinseo will consider the proposed medical applications based on the following guidelines: Category A (Limited Exposure): Trinseo may support the use of Trinseo materials in medical applications involving transient or limited contact with internal human body fluids or tissues, where transient means less than 24 hours. Category B (Prolonged Exposure): Trinseo may support the use of Trinseo materials in medical applications involving contact with internal human body fluids or tissues for up to 29 days. Category C ( Permanent Contact): Trinseo may support the use of Trinseo materials in medical applications involving contact with internal human body fluids or tissues for greater than 29 days. However, in no event will Trinseo support the use of Trinseo materials in medical applications classified as implant devices or birth control devices, defined as applications designed specifically to promote or interfere with human reproduction. If customers, distributors or resellers fail to comply with this Policy, and Trinseo becomes aware of said situation, then Trinseo business units shall take steps required to immediately preclude further sales to that end use. In all of the categories above, Trinseo will exercise its business judgment and conduct appropriate assessments when forming supplier/customer relationships and supplying materials. Trinseo has not designed or tested its products with respect to all possible uses in medical applications. While Trinseo will commit to meet product specifications and quality standards agreed with the customer, it is the responsibility of the medical device or pharmaceutical manufacturer to determine the suitability of the parts and raw materials, including Trinseo products, used in final products to ensure safe, suitable, lawful and technical compliance for the intended end use. 1

3 Turning Ideas into Reality About Trinseo Trinseo is a leading global materials company and manufacturer of plastics, latex and rubber, dedicated to collaborating with customers to deliver innovative and sustainable solutions. Trinseo s technology is used by customers in industries such as home appliances, automotive, building & construction, carpet, consumer electronics, consumer goods, electrical, lighting, medical, packaging, paper & paperboard, rubber goods and tyres. Trinseo Fast Facts More than 70 years of technology and marketplace leadership More than 2,200 employees in 27 countries 67 manufacturing units in 15 production sites 2 major business divisions: Performance Materials, Basic Plastics & Feedstocks Widespread Manufacturing Assets Stade, Germany Terneuzen, Netherlands Tessenderlo, Belgium Midland, MI, USA Schkopau, Germany Norrkoeping, Sweden Hamina, Finland Zhangjiagang, China Boehlen, Germany Ulsan, South Korea Rheinmuenster, Germany Dalton, GA, USA Hsinchu, Taiwan Tsing Yi, Hong Kong Merak, Indonesia Plastics Latex Synthetic Rubber 2

4 Supporting the Medical Industry Trinseo has been supporting the medical devices market with compounded products for single- and multiple-use devices and equipment housings for nearly three decades. As a manufacturer focused on resin quality and product stewardship, we distinguish ourselves by working with our customers strategically, collaboratively and confidentially to solve complex material challenges. Our products are offered under the brand names CALIBRE TM Polycarbonate Resins, CALIBRE TM MEGARAD TM Polycarbonate Resins, EMERGE TM Advanced Resins and MAGNUM TM ABS Resins. Each product shown can be customized to meet specific needs using our technology building blocks and our cross-industry expertise. Most of our grades have been biocompatibility tested; selected products have been US FDA Master Access File listed. 3

5 Product Available for Medical Applications Transparent PC for single-use applications PC with gamma & e-beam radiation resistance for sterilization needs White ABS & PC for portable equipment housings Glass-filled PC for surgical equipment that requires a high degree of structural support & biocompatibility Pre-colored PC/ABS & PC/PET with ignition resistance, biocompatibility & chemical resistant features for device housings Brand Polymer Family Features Recommended Applications CALIBRE TM PC Transparent Opaque Custom-made color & strength available Biocompatibility Fluid & drug delivery: syringes, stopcocks, luers, etc. CALIBRE TM (Glass-filled) PC-GF Opaque High rigidity Biocompatibility Surgical devices: handles & housings CALIBRE TM PC Gamma & E-beam radiation MEGARAD TM resistance Fluid & drug delivery: syringes, stopcocks, luers, etc. Renal care: blood filter housings, dialyzer housings, etc. EMERGE TM PC/ABS PC/PET Outstanding chemical resistance Ignition resistance Biocompatibility Monitoring device: housings & covers MAGNUM TM ABS Superior natural whiteness Pre-colored resins for selected products Excellent lot-to-lot consistency Portable device housing, diabetes management equipments: glucose meters, pumps, insulin pens, etc. STYRON TM Polystyrene Biocompatible Excellent transparency High stiffness and rigidity Clear packaging, petri dishes, diagnostic components, pipettes, etc. 4

6 Trinseo s Product Offerings Grade Features CALIBRE TM Polycarbonate Resins (EtO & Steam Sterilization) Density, g/cm 3 Melt Flow Rate, (g/10 min) Tensile Strength (@ Yield/@ Break, MPa) Break (%) Flexural Modulus (MPa) Impact (23 C, J/m) Instrumented Dart Impact (23 C, J) DTUL (1.8MPa, Unannealed, C) Vicat Softening Temperature ( C) Light Transmission (%) UL Rating (s) ASTM D 792 ASTM D 1238 ASTM D 638 ASTM D 638 ASTM D 790 ASTM D 256 ASTM D 3763 ASTM D 648 ASTM D 1525 AST< D 1003 UL (300 C/1.2kg) 60 / Fluid & drug delivery: syringes, stopcocks, luers, etc (300 C/1.2kg) 60 / High ESCR, High toughness 3.0mm HB (300 C/1.2kg) 62.1 / Good toughness, Balanced features (300 C/1.2kg) 62.1 / Easy processing (300 C/1.2kg) 60 / Good modulus (300 C/1.2kg) 62.1 / Opaque 3.0mm HB 3.0mm HB 3.0mm HB 3.0mm V0 Applications Surgical devices: handles, housings, etc High rigidity (300 C/1.2kg) 62.1 / Opaque Very good modulus (300 C/1.2kg) 82.7 / Opaque 3.0mm V0 3.0mm V0 CALIBRE TM MEGARAD TM Polycarbonate Resins (Gamma & Electron Beam Sterilization) R Lipid-resistant Injection Molding (300 C/1.2kg) 65.5 / Fluid & drug delivery: syringes, stopcocks, luers, etc Injection Molding (300 C/1.2kg) 62.1 / High Flow Injection Molding (300 C/1.2kg) 64.1 / Renal care: blood filter housings, dialyzer housings Designed for oxygen-free irradiation (300 C/1.2kg) 62.1 / EMERGE TM Advanced Resins PC/ABS 7100 MED General Purpose PC/ABS (260 C/5.0kg) 50.3 / Opaque 1.0mm HB Monitoring devices: housings & covers PC/ABS 7700 Ignition-resistant and UV resistance (230 C/3.8kg) 60 / Opaque 1.5mm V0 2.0mm 5VB 2.5mm 5VA PC/ABS 7710 Ignition-resistant (230 C/3.8kg) 60 / Opaque 1.5mm V0 2.0mm 5VB 2.5mm 5VA PC/PET 9100CR MED Chemical-resistant (260 C/5.0kg) 50 / Opaque 1.0mm HB PC/PET 9500CR Chemical-resistant Ignition-resistant (260 C/5.0kg) 53 / Opaque 1.5mm V1 2.0mm V0 2.5mm 5VA MAGNUM TM ABS Resins Portable device housing, diabetes management: glucose meters, pumps, insulin pens 8391 MED High Toughness, High Gloss (230 C/3.8kg) 48 / Opaque 1.5mm HB 5 6

7 Understanding Your Material Needs Trinseo distinguishes itself by taking the time to truly understand our customers needs and expectations, and offering the expertise and knowledge needed for industry-leading, quality focused solutions: Chemical Resistance Trinseo has conducted in-house tests of CALIBRE TM PC Reins and equivalent materials, to evaluate their reaction to chemicals, disinfectants, detergents, food products, cosmetic substances, oil and grease. Biocompatibility Physical, chemical and toxicological testing is done according to ISO and/or USP standards to determine the biocompatibility of various resin grades and color combinations. Over the years, we have collected biocompatibility test data for a wide variety of our products. Sterilization Selected grades of CALIBRE TM PC Resins and MAGNUM TM ABS Resins have been specifically developed to handle a variety of sterilization processes and application requirements, including Steam Autoclaving, Gamma or Electronic Beam (e-beam) Radiation and Ethylene Oxide (EtO). Regulatory Support and Quality Processes We understand that medical regulatory compliance is critical for all manufacturers. Trinseo has developed internal processes to ensure the industry s stringent guidelines are met. As such, our regulatory expertise is recognized and appreciated globally, and we place a strong emphasis on maintaining this leadership position. Trinseo produces its medical grade resins under stringent quality guidelines, controlled conditions and validated processes. 7 Our multiple resin sources provide an assurance of supply. We are committed to providing product consistently, predictably and sustainably. To accommodate formal requirements and the need for documentation, we offer a Management of Change process that includes: Formulation Lock Notification of Change (NOC) Lot Traceability Extended Record and Sample Retention Our goal is to provide end-toend support to our customers. Formulation Lock Extended Record & Sample Retention Management of Change Notification of Change (NOC) Lot Traceability

8 Typical Biocompatibility Testing Grade Polycarbonate Resins Melt Flow Rate (g/10 min) Appearance / Color Reference CALIBRE TM Transparent CALIBRE TM , 15, 22 Transparent /Opaque CALIBRE TM MEGARAD TM , 15, 22 Transparent /Opaque Biocompatibility Testing Complied ISO CALIBRE TM , 15 Opaque CALIBRE TM Opaque - PC/ABS Blend EMERGE TM PC/ABS 7100 MED 25 Natural - EMERGE TM PC/ABS Natural - EMERGE TM PC/ABS Natural - PC/PET Blend EMERGE TM PC/PET 9100CR MED 8.5 Natural - EMERGE TM PC/PET 9500CR 10 Natural - ABS Resins MAGNUM TM 8391 MED 8 Natural - Remarks: - The above are typical properties only and are not to be construed as specifications; users should confirm results by their own tests. - International Organization of Standardization (ISO) Testing includes: Cytoxicity, Delayed Contact Sensitization, Hemolysis Extraction and Direct Contact Method (ASTM method), Implantation Test 7 days, Microscopy of Implants, Intracutaneous Toxicity and Systemic Toxicity. - United States Pharmacopeia (USP) Testing includes Cytoxicity, Hemolysis Extraction and Direct Contact Method (ASTM method), Implantation Test 7 days, Microscopy of Implants, Intracutaneous Toxicity, Systemic Toxicity and Phsicochemical Study. Limited Testing includes a small set of tests conducted according to ISO and/or USP guidelines. USP Applicable Sterilization Technique Grade Steam Autoclave (Cycles) Gamma Radiation Sterilization Technique Electron Beam (e-beam) Radiation Ethylene Oxide (Eto) (Cycles) CALIBRE TM 2060, 2061 Transparent Series Not Applicable Not Applicable Not Applicable Not Applicable 1-5 CALIBRE TM MEGARAD TM 2081 Transparent Series Mrad (25 kgy) 2.5 Mrad (25kGy) Mrad (50 kgy) 5.0 Mrad (50 kgy) Mrad (75 kgy) 7.5 Mrad (75 kgy) 1-5 CALIBRE TM MEGARAD TM 2091 Transparent Series Mrad (25 kgy) 2.5 Mrad (25 kgy) Mrad (75 kgy) 7.5 Mrad (75 kgy) 1-5 MAGNUM TM ABS Series 8391 MED Not Applicable 10 Mrad (100 kgy) 10 Mrad (100 kgy) 1-3 8

9 R & D, Quality & Customer Service Support Sustainability & Corporate Social Responsibility Trinseo s Research & Development and testing laboratories for our plastics business are strategically located across North America, Europe and Asia Pacific. Our technical experts continuously work with our customers to understand ongoing requirements and ensure continuous improvement and innovation throughout our relationships. All of our manufacturing facilities adhere to disciplined quality processes to provide material consistently and reliably, according to specification. In addition, our management system integrates the key elements of several external standards into its best practices, including ISO-9001 and No matter where you are, our global customer service representatives are within reach. You can get immediate assistance through our customer services hotline for issues ranging from a general question about our product offerings to a request for a technical data sheet to a specific handling procedure for a particular product. Trinseo is committed to managing its products in a safe and sustainable manner and we encourage our suppliers and customers to join our efforts to collaborate, innovate, and elevate industrial practices and expectations so that chemical products are managed safely throughout their lifecycle. Trinseo has a robust Ethics and Compliance program and is a Responsible Care company. As a signatory to the Responsible Care Guiding Principles, we are committed to continuously improving our company s performance related to health, safety, and the environment, and to communicate with stakeholders about our products and processes. For more information about our sustainability achievements, please visit our website at 9

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11 For more information on products, innovations, expertise, and other services available from Trinseo, visit or contact us as indicated below. The principles of Responsible Care and Sustainable Development influence the production of printed literature for Trinseo S.A. and its affiliated companies. As a contribution towards the protection of our environments, Trinseo s printed literature is produced in small quantities and on paper containing recovered/post-consumer fiber and using 100 percent soy-based ink whenever possible. PRODUCT STEWARDSHIP Trinseo and its affiliated companies have a fundamental concern for all who make, distribute, and use their products and for the environment in which we live. This concern is the basis for our Product Stewardship philosophy by which we assess the safety, health, and environmental information on our products so that appropriate steps may be taken to protect employee and public health and our environment. The success of our product stewardship program rests with each and every individual involved with Trinseo products from the initial concept and research, to manufacture, use, sale, disposal, and recycle of each product. CUSTOMER NOTICE Customers are responsible for reviewing their manufacturing processes and their applications of Trinseo products from the standpoint of human health and environmental quality to ensure that Trinseo products are not used in ways for which they are not suitable. Trinseo personnel are available to answer questions and to provide reasonable technical support. Trinseo product literature, including safety data sheets, should be consulted prior to the use of Trinseo products. Current safety data sheets are available from Trinseo. No freedom from infringement of any patent owned by Trinseo or others is to be inferred. Because use conditions and applicable laws may differ from one location to another and may change with time, the customer is responsible for determining whether products and the information in this document are appropriate for the customer s use and for ensuring that the customer s workplace and disposal practices are in compliance with applicable legal requirements. Although the information herein is provided in good faith and was believed to be accurate when prepared, Trinseo assumes no obligation or liability for the information in this document. NOTICE REGARDING MEDICAL APPLICATION RESTRICTIONS Trinseo requests that customers refer to Trinseo s Medical Application Policy at before considering the use of Trinseo products in medical applications. The restrictions and disclaimers set forth in that policy are incorporated by reference. Refer to the full medical application policy on the inside back cover. North America TRINSEO ( ) Europe South America Brazil Argentina Chile Colombia Mexico Asia Pacific China CIG@trinseo.com DISCLAIMER TRINSEO MAKES NO WARRANTIES, EITHER EXPRESS OR IMPLIED, IN THIS DOCUMENT; ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE (INCLUDING MEDICAL APPLICATIONS) ARE EXPRESSLY EXCLUDED. TRINSEO DISCLAIMS ANY AND ALL LIABILITY FOR LOSSES OR DAMAGES THAT MAY RESULT FROM THE USE OF TRINSEO PRODUCTS IN UNSUPPORTED USE. TRINSEO MAKES NO WARRANTIES, EXPRESS OR IMPLIED, THAT THE USE OF ANY TRINSEO PRODUCT WILL BE FREE FROM ANY INFRINGEMENT CLAIMS. GENERAL NOTICE Any photographs of end-use applications in this document represent potential end-use applications but do not necessarily represent current commercial applications, nor do they represent an endorsement by Trinseo of the actual products. Further, these photographs are for illustration purposes only and do not reflect either an endorsement or sponsorship of any other manufacturer for a specific potential end-use product or application, or for Trinseo, or for specific products manufactured by Trinseo. If products are described as experimental or developmental : (1) product specifications may not be fully determined; (2) analysis of hazards and caution in handling and use are required; (3) there is greater potential for Trinseo to change specifications and/or discontinue production, and (4) although Trinseo may from time to time provide samples of such products, Trinseo is not obligated to supply or otherwise commercialize such products for any use or application whatsoever. For additional information not covered by the content of this document or to ensure you have the latest version of this document available, please refer to the Customer Information Group contact information on our website at Copyright Trinseo (2017) All rights reserved. Trademark of Trinseo S.A. or its affiliates Responsible Care is a service mark of the American Chemistry Council Form No