clear acrylic resins for the healthcare industry...clear acrylic resins for the healthcare industry...

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Welcome to the World of Altuglas International Altuglas International, a business unit of Arkema Inc., is a global leader in PMMA (polymethylmethacrylate). Altuglas International specializes in technical plastics, developing, manufacturing, and marketing innovative products to meet and exceed our customers’ needs. Its global staff of 1,300 is highly committed to providing product solutions every day. Our main markets include automotive, building and construction, capstocks, LED lighting, and healthcare. Altuglas International has three development priorities: • Create innovative technologies to expand the desirable properties of our sheet and resin. Maintain close partnerships with our customers to understand their needs and deliver solutions quickly. Focus on new developments for medical, transportation, capstocks and optical applications. Our development teams in the U.S. and France specialize in solving customers’ problems, from expanding their process windows to developing new high performance materials. Altuglas International is a reliable, responsible, collaborative manufacturer. Our hallmark is sustained product quality and an experienced worldwide staff. Altuglas International’s products are manufactured in safe, clean facilities that are respectful of their communities and the environment. Headquarters: Arkema France 420, rue d’Estienne d’Orves 92705 Colombes Cedex – France Tel.: +33 (0)1 49 00 80 80 Fax: +33 (0)1 49 00 83 96 arkema.com plexiglas.com CLEAR ACRYLIC RESINS FOR THE Healthcare Industry Performance with Clarity Arkema Inc. Altuglas International Business Center 100 Route 413 Bristol, PA 19007 Tel: 800 523 1532 Fax: 215 826 2796 ARKEMA MEXICO SA DE CV Boulevard Manuel Ávila Camacho No. 2610 Torre A Piso 11-A Col. Valle de los Pinos, 54040 Tlalnepantla de Baz, Estado de México México Tel: +52 55 50027100 Arkema Química Ltda. Av. Ibirapuera, 2033 – 4 andar – Moema 04029-901 – São Paulo, SP Tel: +5511 2148 8522 Arkema Canada Inc. 1100 Burloak Dr, Suite 107 Burlington, ON L7L 6B2 Tel: 905 331 5000 The statements, technical information and recommendations contained herein are believed to be accurate as of the date hereof. Since the conditions and methods of use of the product and of the information referred to herein are beyond our control, ARKEMA expressly disclaims any and all liability as to any results obtained or arising from any use of the product or reliance on such information; NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED, IS MADE CONCERNING THE GOODS DESCRIBED OR THE INFORMATION PROVIDED HEREIN. The information provided herein relates only to the specific product designated and may not be applicable when such product is used in combination with other materials or in any process. The user should thoroughly test any application before commercialization. Nothing contained herein constitutes a license to practice under any patent and it should not be construed as an inducement to infringe any patent and the user is advised to take appropriate steps to be sure that any proposed use of the product will not result in patent infringement. See SDS for Health & Safety Considerations. Arkema has implemented a Medical Policy regarding the use of Arkema products in Medical Devices applications that are in contact with the body or circulating bodily fluids: http://www.arkema.com/en/social-responsibility/responsible-product-management/medical-device-policy/index.html Arkema has designated Medical grades to be used for such Medical Device applications. Products that have not been designated as Medical grades are not authorized by Arkema for use in Medical Device applications that are in contact with the body or circulating bodily fluids. In addition, Arkema strictly prohibits the use of any Arkema products in Medical Device applications that are implanted in the body or in contact with bodily fluids or tissues for greater than 30 days. The Arkema trademarks and the Arkema name shall not be used in conjunction with customers’ medical devices, including without limitation, permanent or temporary implantable devices, and customers shall not represent to anyone else, that Arkema allows, endorses or permits the use of Arkema products in such medical devices. It is the sole responsibility of the manufacturer of the medical device to determine the suitability (including biocompatibility) of all raw materials, products and components, including any medical grade Arkema products, in order to ensure that the final end-use product is safe for its end use; performs or functions as intended; and complies with all applicable legal and regulatory requirements (FDA or other national drug agencies) It is the sole responsibility of the manufacturer of the medical device to conduct all necessary tests and inspections and to evaluate the medical device under actual end-use requirements and to adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks and fulfill any postmarket surveillance obligations. Any decision regarding the appropriateness of a particular Arkema material in a particular medical device should be based on the judgment of the manufacturer, seller, the competent authority, and the treating physician. See SDS for Health & Safety Considerations. PLEXIGLAS ® is a registered trademark of Arkema in the Americas. DR ® is a registered trademark of Arkema. © 2020 Arkema Inc. All rights reserved. Arkema – a French “société anonyme“, registered with the Commercial and Companies Register of Nanterre under number 319 632 790. PPC/SDC/04-2018

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Page 1: CLEAR ACRYLIC RESINS FOR THE Healthcare Industry...CLEAR ACRYLIC RESINS FOR THE Healthcare Industry Performance with Clarity Arkema Inc. Altuglas International Business Center 100

Welcome to the World of Altuglas InternationalAltuglas International, a business unit of Arkema Inc., is a global leader in PMMA (polymethylmethacrylate). Altuglas International specializes in technical plastics, developing, manufacturing, and marketing innovative products to meet and exceed our customers’ needs. Its global staff of 1,300 is highly committed to providing product solutions every day. Our main markets include automotive, building and construction, capstocks, LED lighting, and healthcare.

Altuglas International has three development priorities:• Create innovative technologies to expand the desirable properties of our sheet and resin.

• Maintain close partnerships with our customers to understand their needs and deliver solutions quickly.

• Focus on new developments for medical, transportation, capstocks and optical applications.

Our development teams in the U.S. and France specialize in solving customers’

problems, from expanding their process windows to developing new high

performance materials. Altuglas International is a reliable, responsible,

collaborative manufacturer. Our hallmark is sustained product quality

and an experienced worldwide staff. Altuglas International’s

products are manufactured in safe, clean facilities

that are respectful of their communities and

the environment.

Headquarters: Arkema France420, rue d’Estienne d’Orves

92705 Colombes Cedex – FranceTel.: +33 (0)1 49 00 80 80Fax: +33 (0)1 49 00 83 96

arkema.complexiglas.com

CLEAR ACRYLIC RESINS FOR THE

Healthcare Industry Performance with Clarity™

Arkema Inc.Altuglas International Business Center

100 Route 413 Bristol, PA 19007

Tel: 800 523 1532Fax: 215 826 2796

ARKEMA MEXICO SA DE CVBoulevard Manuel Ávila Camacho No. 2610Torre A Piso 11-ACol. Valle de los Pinos, 54040Tlalnepantla de Baz, Estado de MéxicoMéxicoTel: +52 55 50027100

Arkema Química Ltda.Av. Ibirapuera, 2033 – 4 andar – Moema 04029-901 – São Paulo, SPTel: +5511 2148 8522

Arkema Canada Inc.1100 Burloak Dr, Suite 107Burlington, ON L7L 6B2Tel: 905 331 5000

The statements, technical information and recommendations contained herein are believed to be accurate as of the date hereof. Since the conditions and methods of use of the product and of the information referred to herein are beyond our control, ARKEMA expressly disclaims any and all liability as to any results obtained or arising from any use of the product or reliance on such information; NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED, IS MADE CONCERNING THE GOODS DESCRIBED OR THE INFORMATION PROVIDED HEREIN.

The information provided herein relates only to the specific product designated and may not be applicable when such product is used in combination with other materials or in any process. The user should thoroughly test any application before commercialization. Nothing contained herein constitutes a license to practice under any patent and it should not be construed as an inducement to infringe any patent and the user is advised to take appropriate steps to be sure that any proposed use of the product will not result in patent infringement. See SDS for Health & Safety Considerations. Arkema has implemented a Medical Policy regarding the use of Arkema products in Medical Devices applications that are in contact with the body or circulating bodily fluids: http://www.arkema.com/en/social-responsibility/responsible-product-management/medical-device-policy/index.html

Arkema has designated Medical grades to be used for such Medical Device applications. Products that have not been designated as Medical grades are not authorized by Arkema for use in Medical Device applications that are in contact with the body or circulating bodily fluids. In addition, Arkema strictly prohibits the use of any Arkema products in Medical Device applications that are implanted in the body or in contact with bodily fluids or tissues for greater than 30 days. The Arkema trademarks and the Arkema name shall not be used in conjunction with customers’ medical devices, including without limitation, permanent or temporary implantable devices, and customers shall not represent to anyone else, that Arkema allows, endorses or permits the use of Arkema products in such medical devices.

It is the sole responsibility of the manufacturer of the medical device to determine the suitability (including biocompatibility) of all raw materials, products and components, including any medical grade Arkema products, in order to ensure that the final end-use product is safe for its end use; performs or functions as intended; and complies with all applicable legal and regulatory requirements (FDA or other national drug agencies) It is the sole responsibility of the manufacturer of the medical device to conduct all necessary tests and inspections and to evaluate the medical device under actual end-use requirements and to adequately advise and warn purchasers, users, and/or learned intermediaries (such as physicians) of pertinent risks and fulfill any postmarket surveillance obligations. Any decision regarding the appropriateness of a particular Arkema material in a particular medical device should be based on the judgment of the manufacturer, seller, the competent authority, and the treating physician.

See SDS for Health & Safety Considerations.

PLEXIGLAS® is a registered trademark of Arkema in the Americas. DR® is a registered trademark of Arkema. © 2020 Arkema Inc. All rights reserved.

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Page 2: CLEAR ACRYLIC RESINS FOR THE Healthcare Industry...CLEAR ACRYLIC RESINS FOR THE Healthcare Industry Performance with Clarity Arkema Inc. Altuglas International Business Center 100

Plexiglas® Acrylic ResinsHealthcare ApplicationsThe healthcare industry has utilized Plexiglas® acrylic resins for decades in applications that require exceptional clarity, lipid and plasticizer resistance, and the ability to be UV and e-beam sterilized. Several Plexiglas® acrylic resins can also be gamma sterilized.

Light Transmission & HazePlexiglas® VS-UVT acrylic resin exhibits excellent UV transmission and low haze and is commonly used in disposable diagnostic devices. Plexiglas® SG-grade acrylic resins are impact-modified and designed to provide excellent light transmission and water-white clarity for demanding healthcare device applications.

Radiation ResistancePlexiglas® SG-grade acrylic resins exhibit excellent resistance to discoloration after exposure to high-energy sterilization processes such as gamma and e-beam sterilization.

Device components molded from Plexiglas® SG-grade resins start clearer and stay clearer after 40 kGray of gamma radiation, with minimal yellowing and discoloration. This translates to shorter waiting periods for device shipments and lower stock inventory requirements. These impact-modified resins also maintain their impact strength, tensile modulus, and tensile strength, even after high-energy sterilization.

Plexiglas® VS-UVT Acrylic Resin UV-Transmitting Resin for Medical Diagnostics

Key Performance Criteria

Typical Physical Properties of Plexiglas® Acrylic Resins

Applications• iv delivery• blood separation• diagnostic devices• respiratory canisters

• connectors• dialysis equipment• cuvettes• incubators

• valves• filter housings• surgical instruments• luers

Chemical Resistance• lipids• plasticizers• blood• oncology drugs• antiseptics• acids• bases• bleach• alcohols

Excellent Optics• water-white clarity• low haze• UV transparency

Sterilization• gamma• e-beam• ethylene oxide (EtO)• UV

Easy Processing and Fabrication• injection molding• solvent, adhesive,

& thermal bonding• extrusion• blow molding

Sustainability• bisphenol-A (BPA) free • plasticizer free• halogen free• free of heavy metals

PLEXIGLAS® GRADE SG10 HFI10G-100 DR®-100G DR®-66021G White SG7 MI7G-100 VS-UVT V045-100G

GENERAL CHARACTERISTICS

high impact, medium flow

high impact, medium flow

high impact, low flow

high impact, low flow

medium impact, high flow

medium impact, medium flow

highest flow, UV-transparent

high stiffness, low flow

PROPERTIES TEST METHOD UNITS

REGULATORY

USP Class VI Yes Yes Yes Yes Yes Yes Yes Yes

ISO 10993-4 & -5 Yes Yes Yes Yes Yes Yes Yes Yes

STERILIZATION

gamma (color stability) Yes Yes No No Yes Yes No No

e-beam, ethylene oxide (EtO), UV Yes Yes Yes Yes Yes Yes Yes Yes

PHYSICAL

Melt Flow (230°C/3.8 kg) ASTM D1238 g/10 min 4.5 3.3 1.0 0.9 12 3.2 27 2.3

Specific Gravity ASTM D792 – 1.15 1.15 1.15 1.15 1.17 1.17 1.18 1.19

Mold Shrinkage ASTM D955 % 0.3 - 0.7 0.3 - 0.8 0.3 - 0.8 0.3 - 0.8 0.3 - 0.6 0.3 - 0.6 0.2 - 0.6 0.2 - 0.6

Water Absorption (24 hr immersion) ASTM D570 % weight gain 0.4 0.4 0.4 0.4 0.3 0.3 0.3 0.3

MECHANICAL

Tensile Strength @ Maximum ASTM D638 psi 5,300 5,500 5,500 5,600 6,800 7,000 9,400 10,200

Tensile Elongation @ Break ASTM D638 % 50 50 50 42 35 35 3 6

Tensile Modulus ASTM D638 psi 270,000 270,000 270,000 245,000 355,000 365,000 420,000 450,000

Flexural Strength @ Maximum ASTM D790 psi 10,300 10,300 10,300 8,700 12,400 11,200 14,000 15,000

Flexural Modulus ASTM D790 psi 270,000 270,000 270,000 250,000 355,000 345,000 430,000 450,000

Notched Izod Impact (73°F/23°C) ASTM D256 ft•lb/in notch 0.9 0.9 1.1 0.9 0.6 0.6 0.3 0.3

Rockwell Hardness ASTM D785 M 38 38 45 45 60 68 84 91

THERMAL

HDT (0.45 MPa) ASTM D648 °F/°C 190/88 192/89 192/89 192/89 190/88 196/91 177/80 202/94

Vicat Softening Point (50°C/hr; 50N) ASTM D1525 °F/°C 176/80 181/83 187/86 187/86 182/84 194/90 178/81 207/97

OPTICAL

Refractive Index (N0 @ 73°F/23°C) ASTM D542 – 1.49 1.49 1.49 n/a 1.49 1.49 1.49 1.49

Luminous Transmittance (0.125 in/3.2 mm) ASTM D1003 % 90 90 90 n/a 91 91 92 92

Haze (0.125 in/3.2 mm) ASTM D1003 % <2 <2 <2 n/a <2 <2 <1 <1

Note: The data above represents average values and should not be used for specification purposes.

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%Plexiglas® VS-UVT Plexiglas® SG Lipid-Resistant PC Medical Grade

CoPEMedical Grade Styrene-Acrylic Multipolymers

TRANSMISSION AND HAZE OF COLORLESS RESINS

LIGH

T TR

ANSM

ISSI

ON

HAZE

10%

9%

8%

7%

6%

5%

4%

3%

2%

1%

0%

HazeLight Transmission

15

10

5

0

-5

-10

-15

Y1 AFTER 40 KGRAY GAMMA IRRADIATION

YELL

OWNE

SS I

NDEX

D A Y S A F T E R I R R A D I A T I O N

Plexiglas® SG PMMA Lipid Resistant PC Styrene-Acrylic Multipolymer

1 2 3 4 5 6 7

Regulatory ComplianceCompliance

• USP CLASS VI• ISO 10993

Plexiglas® SG7-101, SG10-101, DR-66021G, DR-100G, DRG-100, HFI10G-100, MI7G-100, VSUVT-100, and V045-100G resins meet the testing requirements for USP Class VI, ISO 10993-4:2002 (Hemocompatibility), and ISO 10993-5:2009 (Cytotoxicity). Compliance information is available on request.

100

80

60

40

20

0250 275 300 325 350 375 400

SPECTRAL TRANSMISSION OF PLEXIGLAS® VS-UVT MEDICAL RESIN @ 3.2mm THICKNESS

LIGH

T TR

ANSM

ISSI

ON (

%)

W A V E L E N G T H ( n m )

Plexiglas® VS-UVT acrylic resin exhibits excellent UV transmission and has a high melt flow rate, enabling its use in thin-wall medical devices, as well as complex, high-volume diagnostic devices. This resin provides low levels of fluorescence, which is easily characterized and subtracted from sample emissions.