Materials. Powering Ideas.
Asia Pacific
High Performance
Medical Grade Resins
for Single- & Multiple-Use Devices and
Equipment Housings
Trinseo Medical Application Policy which is set forth below:
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 10993 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 10993-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 10933-1:2009 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.
Notice Regarding
Medical Application
Restrictions
Widespread Manufacturing Assets Dalton, GA Norrkoeping, Sweden Tessenderlo, Belgium Terneuzen, Netherlands Stade, Germany Hamina, Finland Rheinmuenster, Germany Livorno, Italy
Ulsan, South Korea Zhangjiagang, China
Hsinchu, Taiwan Tsing Yi, Hong Kong
Merak, Indonesia Guaruja, Brazil Limao, Brazil Midland, MI Allyn’s Point, CT Schkopau, Germany Boehlen , Germany Plastics Latex Synthetic Rubber Ehime, Japan (Joint Venture)
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.
Fast Facts Trinseo
More than 70 years of technology and marketplace leadership
More than 2,100 employees in 27 countries 67 manufacturing units in 19 production sites 2 major business divisions: Performance Materials,
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.
Supporting the
Medical Industry
Our products are offered under the brand names
CALIBRETM Polycarbonate Resins, CALIBRETM
MEGARADTM Polycarbonate Resins, EMERGETM
Advanced Resins and MAGNUMTM 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.
Product Available
for Medical Applications
Brand Polymer Family Features Recommended Applications
CALIBRETM PC •Transparent
•Opaque
•Custom-made color & strength available
•Biocompatibility
•Fluid & drug delivery: syringes, stopcocks, luers, etc.
CALIBRETM
(Glass-filled) PC-GF ••OpaqueHigh rigidity
•Biocompatibility
• Surgical devices: handles & housings
CALIBRETM
MEGARADTM PC •resistanceGamma & E-beam radiation •Fluid & drug delivery: syringes, stopcocks, luers, etc.
•Renal care: blood filter housings, dialyzer housings, etc.
EMERGETM PC/ABS
PC/PET •resistanceOutstanding chemical
• Ignition resistance
•Biocompatibility
• Monitoring device: housings & covers
MAGNUMTM 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.
Pre-colored PC/ABS & PC/PET with ignition resistance, biocompatibility & chemical resistant features for device housings
White ABS & PC for portable equipment housings Transparent PC for single-use applications PC with gamma & e-beam radiation resistance for sterilization needs Glass-filled PC for surgical equipment that requires a high degree of structural support & biocompatitbility
Grade Features
Density, g/cm3
Melt Flow Rate, (g/10 min) Tensile Strength (@ Yield/@ Break, MPa) Elongation @ Break (%) Flexural Modulus (MPa) Impact (23°C, J/m) ASTM D 792 ASTM D 1238 ASTM D 638 ASTM D 638 ASTM D 790 ASTM D 256 CALIBRETM Polycarbonate Resins (EtO & Steam Sterilization)
2060-3
High ESCR, High toughness
1.2 3 (300°C/1.2kg) 60 / 72.4 150 2410 910
2061-3 1.2 3 (300°C/1.2kg) 60 / 72 150 2410 960
2061-6 1.2 6 (300°C/1.2kg) 62.1 / 68.3 150 2410 850
2061-15 Balanced featuresGood toughness, 1.2 15 (300°C/1.2kg) 62.1 / 68.3 150 2410 750 2061-22 Easy processing 1.2 22 (300°C/1.2kg) 60 / 65.5 120 2410 750 5101-8 Good modulus 1.27 8 (300°C/1.2kg) 62.1 / 60.7 6.0 3170 80 5101-15 High rigidity 1.27 15 (300°C/1.2kg) 62.1 / 60.7 6.0 3170 80 5201-12 Very good modulus 1.36 12 (300°C/1.2kg) 82.7 / 82.7 3.0 4830 110
CALIBRETM MEGARADTM Polycarbonate Resins (Gamma & Electron Beam Sterilization)
2081-6R Injection MoldingLipid-resistant 1.2 6 (300°C/1.2kg) 65.5 / 68.3 130 2410 850
2081-15 Injection Molding 1.2 15 (300°C/1.2kg) 62.1 / 68.3 150 2410 750
2081-22 High Flow Injection Molding 1.2 22 (300°C/1.2kg) 64.1 / 46.9 180 - 750
2091-15 Designed for oxygen-free irradiation 1.2 15 (300°C/1.2kg) 62.1 / 68.3 150 2410 750
EMERGETM Advanced Resins
PC/ABS 7100 MED General Purpose PC/ABS 1.11 25 (260°C/5.0kg) 50.3 / - 50 2430 480 PC/ABS 7600 Ignition-resistant 1.18 19 (230°C/3.8kg) 55.2 / 44.1 80 2830 590 PC/ABS 7700 Ignition-resistant and UV resistance 1.17 11 (230°C/3.8kg) 60 / 48.3 65 2690 480 PC/ABS 7710 Ignition-resistant 1.17 11 (230°C/3.8kg) 60 / 48.3 65 2690 480 PC/PET 9100CR Chemical-resistant 1.23 8.5 (260°C/5.0kg) 50 / 56.2 150 2100 910 PC/PET 9500CR Chemical-resistantIgnition-resistant 1.29 10 (260°C/5.0kg) 53 / 45 150 2270 750
MAGNUMTM ABS Resins
8391 MED High Toughness, High Gloss 1.05 8 (230°C/3.8kg) 48 / 35 8.7 2480 230
Trinseo’s Product
Offerings
Instrumented Dart Impact (23°C, J) DTUL (1.8MPa, Unannealed, °C) Vicat Softening Temperature (°C) Light Transmission (%) UL Rating (s) Applications ASTM D 3763 ASTM D 648 ASTM D 1525 AST< D 1003 UL 94
90 129 156 89 - Fluid & drug delivery: syringes, stopcocks, luers, etc. 93.8 132 151 89 1.5mm V23.0mm HB
89.3 129 156 89 3.0 mm HB1.5mm V2 81.3 122 148 89 3.0 mm HB1.5mm V2 72.3 126 152 89 3.0 mm HB1.5mm V2
40.1 134 160 Opaque 3.0 mm V01.5mm V2 Surgical devices: handles, housings, etc. 40.1 134 160 Opaque 3.0 mm V01.5mm V2
46.3 138 159 Opaque 3.0 mm V01.5mm V2
89.3 129 151 85
-Fluid & drug delivery: syringes, stopcocks, luers, etc.
Renal care: blood filter housings, dialyzer housings
81.3 122 148 85
-- 123 - 85
-81.3 122 148 85
-- 95 133 Opaque 1.0 mm HB Monitoring devices: housings & covers - 77.2 102 Opaque 2.0mm 5VB1.5mm V0 - 79.4 104 Opaque 2.0mm 5VB1.5 mm V0 - 79.4 104 Opaque 2.0mm 5VB1.5 mm V0 63.3 87.2 144 Opaque 1.0mm HB 60 79 140 Opaque 2.0mm V01.5mm V1 2.5mm 5VA - 74 99 Opaque 1.5mm HB
Portable device housing, diabetes management: glucose meters, pumps, insulin pens
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:
Understanding Your
Material Needs
Chemical Resistance
Trinseo has conducted in-house tests of CALIBRETM 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 10993 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 CALIBRETM PC Resins and MAGNUMTM 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).
Quality
Processes
Trinseo produces its medical grade resins under stringent quality guidelines, controlled conditions and validated processes. 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:
Lot Traceability Formulation Lock Notification of Change Extended Record and Sample
Retention
Our goal is to provide end-to-end support to our customers.
Notification of Change
Extended Record & Sample
Retention Lot Traceability Formulation Lock Management of Change
Typical
Biocompatibility Testing
Applicable
Sterilization Technique
Grade Melt Flow Rate(g/10 min) Appearance / Color Reference Biocompatibility Testing Complied
ISO 10993 USP
Polycarbonate Resins
CALIBRETM 2060 3 Transparent
CALIBRETM 2061 6, 15, 22 Transparent /Opaque
CALIBRETM MEGARADTM 2081 6, 15, 22 Transparent /Opaque
CALIBRETM 5101 8, 15 Opaque
CALIBRETM 5201 12 Opaque
-PC/ABS Blend
EMERGETM PC/ABS 7600 Advanced Resin 19 Natural
-EMERGETM PC/ABS 7700 Advanced Resin 11 Natural
-EMERGETM PC/ABS 7710 Advanced Resin 11 Natural
-PC/PET Blend
EMERGETM PC/PET 9100CR Advanced Resin 8.5 Natural
-EMERGETM PC/PET 9500CR Advanced Resin 10 Natural
-ABS Resins
MAGNUMTM 8391 MED 8 Natural
-Grade
Sterilization Technique Steam
Autoclave
(Cycles) Gamma Radiation
Electron Beam (e-beam) Radiation
Ethylene Oxide (Eto) (Cycles) CALIBRETM 2060, 2061 Transparent Series
2060 030003 1-5 Not Applicable Not Applicable 1-5
2061 030003 1-5 Not Applicable Not Applicable 1-5
CALIBRETM MEGARADTM 2081 Transparent Series
2081 030006 1-5 2.5 Mrad (25 kGy) 2.5 Mrad (25kGy) 1-5
2081 030116 1-5 5.0 Mrad (50 kGy) 5.0 Mrad (50 kGy) 1-5
2081 030105 1-5 7.5 Mrad (75 kGy) 7.5 Mrad (75 kGy) 1-5
CALIBRETM MEGARADTM 2091 Transparent Series
2091 030006 1-5 2.5 Mrad (25 kGy) 2.5 Mrad (25 kGy) 1-5
2091 030105 1-5 7.5 Mrad (75 kGy) 7.5 Mrad (75 kGy) 1-5
MAGNUMTM ABS Series
8391 MED Not Applicable 10 Mrad (100 kGy) 10 Mrad (100 kGy) 1-3
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) 10993 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.
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 1400.
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 www.trinseo.com/sustainability
R & D, Quality
&
Customer Service
Support
Sustainability
&
Corporate Social
Responsibility
For more information on products, innovations, expertise, and other services available from Trinseo, visit www.trinseo.com, or contact us as indicated below.
www.trinseo.com
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 http://www.trinseo.com/medical.htm 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.
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 MEDICAL APPLICATIONS. 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 www.trinseo.com/contact/.
Copyright© Trinseo (2015) All rights reserved. ™Trademark of Trinseo S.A. or its affiliates
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