Tubing, Hoses and Sheeting

Transcription

1 TRELLEBORG SEALING SOLUTIONS Tubing, Hoses and Sheeting FOR HEALTHCARE AND MEDICAL APPLICATIONS YOUR PARTNER FOR SEALING TECHNOLOGY

2 Your Partner for Sealing Technology Trelleborg Sealing Solutions is a major international developer, manufacturer and supplier of seals, bearings and molded components in polymers. We are uniquely placed to offer dedicated design and development from our market-leading product and material portfolio: a one-stop-shop providing the best in elastomer, silicone, thermoplastic, PTFE and composite technologies for applications in aerospace, industrial and automotive industries. With years of experience, Trelleborg Sealing Solutions engineers support customers with design, prototyping, production, test and installation using state-of-the-art design tools. An international network of over 70 facilities worldwide includes over 20 manufacturing sites, strategically-positioned research and development centers, including materials and development laboratories and locations specializing in design and applications. Developing and formulating materials in-house, we utilize the resource of our material database, including over 2,000 proprietary compounds and a range of unique products. Trelleborg Sealing Solutions fulfills challenging service requirements, supplying standard parts in volume or a single custom-manufactured component, through our integrated logistical support, which effectively delivers over 40,000 sealing products to customers worldwide. Facilities are certified to ISO 9001:2008 and ISO/TS 16949:2009. Trelleborg Sealing Solutions is backed by the experience and resources of Trelleborg Group, one of the world s foremost experts in polymer technology. ISO 9001:2008 ISO/TS 16949:2009 ISO The information in this brochure is intended to be for general reference purposes only and is not intended to be a specific recommendation for any individual application. The application limits for pressure, temperature, speed and media given are maximum values determined in laboratory conditions. In application, due to the interaction of operating parameters, maximum values may not be achieved. It is vital therefore, that customers satisfy themselves as to the suitability of product and material for each of their individual applications. Any reliance on information is therefore at the user s own risk. In no event will Trelleborg Sealing Solutions be liable for any loss, damage, claim or expense directly or indirectly arising or resulting from the use of any information provided in this brochure. While every effort is made to ensure the accuracy of information contained herewith, Trelleborg Sealing Solutions cannot warrant the accuracy or completeness of information. To obtain the best recommendation for a specific application, please contact your local Trelleborg Sealing Solutions marketing company. This edition supersedes all previous brochures. This brochure or any part of it may not be reproduced without permission. All trademarks are the property of Trelleborg Group. The turquoise color is a registered trademark of Trelleborg Group. 2017, Trelleborg Group. All rights reserved. 2 TRELLEBORG SEALING SOLUTIONS

3 Contents 04 Introduction 18 Custom Products 06 The Complete Toolbox 20 Braided Silicone Hoses 08 Cleanroom Production 22 Wrapped Hose 10 Sterilization 23 Premium Grade Silicone Tubing 14 Advanced Elastomers 24 Platinum-Cured Single Lumen 16 Product Range 26 Sheeting TRELLEBORG SEALING SOLUTIONS 3

4 TRELLEBORG SEALING SOLUTIONS Pioneering Innovations Global Supplier Trelleborg Sealing Solutions is a leading global supplier of high quality precision seals, bearings and custom-molded polymer components, including tubing, hose and sheeting. We manufacture a complete line of medical-grade tubing for all types of applications, from medical to appliances. The highest grades of laboratory - tested silicone materials, carrying necessary approvals and certifications combined with decades of application experience, make Trelleborg Sealing Solutions uniquely able to create customengineered tubing and hose solutions. Innovative Online Tools Read the Book. See the Movie. Now that you have the brochure, why not check out our medical & healthcare video on YouTube! Providing local support globally, our network of over 80 facilities offers: Worldwide logistics that ensure products are delivered on time, wherever you are in the world, or wherever you are going One-stop-shop to consolidate supplier bases, reducing costs and simplifying business Product Innovations that improve service life and reduce total cost of ownership Performance Without Compromise While Trelleborg Sealing Solutions can supply standard products, by understanding the whole application, we can apply our extensive knowledge to value engineer our solutions for your challenges. Trelleborg s engineers and R&D teams can create holistic solutions that increase hygiene or remove additional production steps with innovative manufacturing techniques. We can provide special kitting and assembly solutions and advanced delivery projects, to ensure the product is where you want it and ready to use. Apps at the Slide of a Finger Check out our latest engineering tools for smart phones: Life Sciences Material Compatibility Tubing & Hose Selector ISO Fits & Tolerances Online Services and Tools at the Click of a Mouse Trelleborg Sealing Solutions offers a range of cutting-edge online services and tools on our website. Full range of Catalogs and Brochures Sealing Solutions Configurator CAD Service O-Ring Calculator 4 TRELLEBORG SEALING SOLUTIONS

5 TRELLEBORG SEALING SOLUTIONS Developed Together Leading manufacturers rely on Trelleborg Sealing Solutions for innovative design support, world-class manufacturing technology and quality assured components. Design engineering and dedicated research and development teams, utilizing decades of material expertise, work with you to develop solutions that optimize product performance. Best-in-class materials, from elastomers to plastics, certified or compliant with regional medical and pharmaceutical standards and regulations Decades specifying solutions and tailoring them specifically to applications Extensive manufacturing and service capabilities, such as cleanroom facilities and advanced delivery options Research and development support, including testing and qualification Innovation and Reliability Our innovation is a key to your success. Solving tubing and hose application challenges using pioneering techniques, we deliver better performance and overall profitability for our customers. Our international logistics network can meet your scheduling requirements. Wherever a product is originally designed, our global manufacturing capabilities and responsive supply chain allow us to deliver our solutions to the same specification and quality standards wherever you are located, following your production as it expands globally with local support. Our Global Resources 5,800 employees How local is your global seal supplier? 82 worldwide locations More than 2,000 proprietary materials 9 Research & Development Centers 53 Marketing Companies 4 Logistics Centers 28 Manufacturing Sites Damping Solutions 5 Automotive Hubs 9 Aerospace Hubs TRELLEBORG SEALING SOLUTIONS 5

6 THE COMPLETE TOOLBOX The complete toolbox Providing the right solution for an application can be challenging. At Trelleborg Sealing Solutions we employ a complete toolbox of skills and expertise to make sure that the best result is achieved every time. DESIGN OF PRODUCT MATERIAL Partnering with the world's leading material developers Application and processing experts To customer specification or 'black box' design Best fit, form and function Robustness in manufacturability Quality in mind Quality by Design CLEANROOM OR STANDARD PRODUCTION Class 7 and 8 to ISO Ultra lean and clean 6 TRELLEBORG SEALING SOLUTIONS

7 THE COMPLETE TOOLBOX PROCESS Lean Flashless and wasteless principles Robust APQP process In-process quality control Zero-Defect quality culture TOOLING Precision manufacture of die and mandrel Proprietary designs Innovation-driven EXTRUSION Long standing experience in extrusion of silicone hose & tubes Patented special processes such as GeoTrans TECHNICAL SKILLS AUTOMATION State-of-the-art equipment Customized, fit-for-purpose solutions for the highest efficiency and quality Our biggest asset Tradition of apprenticeship, training and continuous improvement Outstanding skill levels based on extensive technical experience TRELLEBORG SEALING SOLUTIONS 7

8 CLEANROOM PRODUCTION Key benefits Produced in a Class 100,000 (ISO 8) environment Double-bagged in a Class 10,000 (ISO 7) environment Capable of handling lots from several thousand up to millions of pieces / meter of tubings Site certifications to ISO 9001, ISO and ISO TRELLEBORG SEALING SOLUTIONS

9 CLEANROOM PRODUCTION Cleanroom Production Components for the medical, pharmaceutical, healthcare and medical industries require the highest levels of cleanliness at all steps of production to meet stringent hygienic standards. The need for germ- and contaminant-free components and environments is ever increasing, and as parts become smaller, they are more sensitive to airborne particles, even those found normally in the air. When superclean products are a requirement for your application, Trelleborg Sealing Solutions offers cleanroom services to ensure this. To serve customers globally Trelleborg Sealing Solutions has installed high-tech cleanrooms conforming with ISO in the Americas, Asia and Europe. These work to a set of stringent internal technical and operating standards in order to guarantee the utmost level of quality, cleanliness, hygiene and process control. If cleanroom manufacturing is not needed, standard production is available. The majority of our tubing is manufactured in a controlled environment to class 100,000 conditions. We regularly monitor ambient temperature, humidity and particulate counts, as standard. Special requirements In addition to cleanroom operations, Trelleborg Sealing Solutions offers a wide range of special finishing operations and services such as: Special washes, such as acetone washes Product coatings and surface modification Product sterilization Special customized packaging Reduction or elimination of secondary operations, such as: - assembly - cutting-to-length - overmolding. TRELLEBORG SEALING SOLUTIONS 9

10 STERILIZATION Sterilization WITHSTANDING SERVERE CLEANING REGIMES The Healthcare and Medical industries presents exceptionally demanding environments for tubing, hoses and seals. These products must not only be compatible with system media, but also stringent cleaning regimes. Modern cleaning procedures support production efficiency, prevent toxic and microbial contamination of products and minimize contamination during the process. However, aggressive media used in automated CIP (Cleaning in Place), SIP (Sterilization in Place) and disinfection procedures can shorten tubing and hose life. Complex formulations of chemicals can rapidly cause severe damage to plastics and elastomers, especially in applications with load and pressure. With high temperatures and steam sterilization, this deterioration is sometimes dramatically intensified. As hygiene requirements increase, more cleaning agents and disinfectants are being used. To extend equipment life, working with a supplier that understands materials and processes critical to maximizing efficiency and reducing total cost of ownership, is vital. Trelleborg Sealing Solutions supports you every step of the way in specifying the right specialized elastomer grades that make certain products will withstand emerging CIP and SIP procedures. 10 TRELLEBORG SEALING SOLUTIONS

11 STERILIZATION TRELLEBORG SEALING SOLUTIONS 11

12 STERILIZATION SILICONE: THE OPTIMUM CHOICE IN STERILIZATION PROCESSES When designing new medical devices, selecting the correct materials and processing techniques are fundamental considerations. Not only must the materials meet functionality requirements and carry a number of certificates and approvals, but also cope with destructive cleaning media. With multidrug resistant microbes causing potential infections, the sterility of medical devices and instruments is a vital necessity. A single-use devices need only withstand one cycle of sterilization, multiuse devices have to cope with the repeated impact of these highly aggressive treatments. There are a number of different sterilization methods used in practice, ranging from radiation to steam and EtO, but most of them involve high energy to ensure aggressive pathogens are killed. With elastomers, high levels of energy results in changes at the molecular level, like unwanted crosslinking or chain scissoring, leading to deterioration over time and a loss of important physical properties, such as flexibility and tensile strength. Trelleborg Sealing Solutions has developed specialized compounds with proven compatibility and resistance to sterilization processes and can aid in selecting the ideal compound, preventing failures which could result in risks to a patient s wellbeing. Special behavior of silicone As an example of an important material consideration, take an elastomer product with small holes, inherent to the function of the component. Due to high energy sterilization regimes involving radiation, the holes could heal over, resulting on a total loss of functionality. When deciding on a material for this kind of application, it is important to work with an experienced supplier who understands the physical effects of sterilization on seal life. In this instance, due to its biocompatibility and resistance to aging, temperature and many chemicals, silicone would be used, as it frequently is for the modern medical device markets and harsh sterilization regimes. Steam Sterilization at +134 C for 5 minutes A steam autoclave is commonly used to sterilize reusable medical devices. This will most likely have little effect on the physical properties of silicone because of its moisture and heat resistance Hardness / Compression set / Tensile Strength Sterilization cycles - Steam +134 C Hardness Shore A Compression Set [%] Tensile Strength [N/mm²] Elongation at break [%] Elongation at break Figure 1: Physical behavior of silicone during steam sterilization 12 TRELLEBORG SEALING SOLUTIONS

13 STERILIZATION Ethylene Oxide Sterilization (EtO) EtO penetrates microbial cells, destroying nuclear cell components. Silicones generally have a high permeability to gases compared to most elastomeric materials, permitting the EtO molecules to diffuse through the polymer network, sterilizing throughout the entire polymer matrix Hardness / Compression set / Tensile Strength Elongation at break EtO Sterilization [mg/l] Hardness Shore A Compression Set [%] Tensile Strength [N/mm²] Elongation at break [%] Figure 2: Physical behavior of silicone during EtO sterilization Gamma Sterilization Gamma radiation and e-beam are alternative sterilization methods for heat sensitive devices and devices that are not permeable to gasses used in chemical sterilization. A major concern for many device manufacturers is that radiation may damage or degrade polymeric materials Hardness / Compression set / Tensile Strength γ-radiation [kgy] Hardness Shore A Compression Set [%] Tensile Strength [N/mm²] Elonga on at break [%] Elongation at break Figure 3: Physical behavior of silicone during Gamma sterilization TRELLEBORG SEALING SOLUTIONS 13

14 ADVANCED ELASTOMERS Elastomers with Unique Capabilities BENEFITS OF SILICONE Silicone is an extremely versatile material that lends itself to a broad range of application conditions. Silicone offers advantages in processing that make it a optimal choice of material for technical components in small to high volumes. Available in hardnesses from 5 up to 90 Shore - LSR Silicone: 5-90 Shore A - HCR Silicone: Shore A Platinum curing gives the highest purity material Excellent low and high temperature resistance Offers outstanding resistance to ozone, weather and UV rays Hydrophobic Offers excellent mechanical damping properties Possesses outstanding electrical insulation and available in UL94 listed types Specific to food contact applications: - Compliant with FDA, BfR, NSF - Neutral in taste and odor Specific to potable water applications: - Compliant with WRAS, KTW, ACS, NSF Specific to biomedical and pharmaceutical applications: - Highest purity - Biocompatibility to ISO and USP Class VI - Compliant with European Pharmacoepia Withstands common sterilization methods such as dry heat, steam, gamma radiation, EtO Masterfiles available for long-term implantable silicones for applications greater than 29 days Biologically inert, so first joice for long-term implements Media resistance of silicone (VMQ) in IRM 903 oil > Service temperature ( C / F ) PTFE FKM FVMQ ACM HNBR TPE-E ECO NBR VMQ EVM/AEM > Swelling in oil (IRM 903) (%) Working temperature range of silicone (VMQ) against other elastomer types CR FFKM NR FKM EPDM ACM VMQ SBR EPDM IIR BR NBR HNBR EAM NR > Temperature (oc / of) 14 TRELLEBORG SEALING SOLUTIONS

15 ADVANCED ELASTOMERS BENEFITS OF THERMOPLASTIC ELASTOMERS (TPE) TPEs are copolymer mixtures of rubber and plastic, exhibiting properties of both materials. The material consists of a hard and a soft segment. The hard segments are responsible for the hardness and stiffness of the material. The soft segments give the materials their flexibility and elasticity. They require virtually no compounding, reinforcing agents, stabilizers or curing agents, providing consistent batch-to-batch properties, leading to consistent performance in application. The absence of any natural ingredients in the formulation leads to a very pure material, free from any allergens or other natural impurities. Translucent, flexible and resists kinking, making it ideal for pumping and fluid transfer Weldable and heat-sealable Recyclable Lower permeability than silicone Can be sterilized with gamma radiation or in an autoclave Min Temp. - C / -60 F Max Temp C / +275 F Hardness 70 Shore A Compliances USP Class VI, FDA, 3-A, NSF and European sanitary standards TRELLEBORG SEALING SOLUTIONS 15

16 PRO D U C T R A N G E Product Range STANDARD TUBING TUBING STYLES Trelleborg Sealing Solutions manufactures tubing for demanding applications. Our range includes standard tubing in addition to specialized and customized solutions. Tubing and hose can be produced in a variety of styles to adapt to specific applications or to add benefits in addition to those of the material chosen. Silicone Tubing and Hose Multi-Lumen Tubing High purity, performance and biocompatibility Multiple channels for separating fluids or wires in one tube Key Benefits Platinum-cured for a high degree of purity Extended post-cure for lowest levels of extractables and leachables Biocompatible, inert and non-reactive with other elements per systemic testing Odorless, tasteless, non-toxic: for use in medical, food, drug, personal care, and deionized water applications Sterilizable by radiation, EtO, steam possible Resists temperature extremes and retains flexibility: -60 C to +200 C / -76 F to 392 F Color striping for custom process control identification Key Benefits Numerous lumens or channels with differing diameters Over-molded to connector to separate lumen into individual tubes Allows multiple, discrete paths within a single extrusion Precision assemblies facilitated by compact spacing of lumen Translucent for visual monitoring, and available colored for fast identification Braid-Reinforced Hose Key Benefits Less invasive for devices that will be inserted into human body, such as catheters and endoscopes Allows reduction in size of medical devices Suitable for demanding applications, withstanding cleaning, sterilization and high pressure Key Benefits High pressure ratings Sterilizable and autoclavable Platinum grade Resists extreme temperatures and retains flexibility: -60 C to +200 C / -76 F to 392 F Pigmented outer covers available Available in bulk assemblies Do you have specific requirements? Contact us! For details of your nearest Trelleborg Sealing Solutions marketing company go to 16 TRELLEBORG SEALING SOLUTIONS Thin Wall Tubing Lower space requirements while retaining benefits Corrugated Tubing Permitting bending while preventing pinching Key Benefits Ideal for respiratory and anesthesia applications Corrugated ID with smooth ID, allowing greater bending than regular tubing without pinching

17 PRO D U C T R A N G E ADVANCED ENGINEERED SOLUTIONS Trelleborg Sealing Solutions has dedicated teams of engineers on hand to develop customized solutions featuring jacketing of components and other special features to enhance performance, provide unique benefits and reduce processing steps. Custom Peristaltic Pump Tubing High performance silicone pump solutions Key Benefits Designed to meet specific application Consistent long-term flow rates Offered in flexible and chemically resistant silicone tubing Helps pump achieve consistent flow rates while reducing the effects of hysteresis and spallation Stops can be added using bonding or overmolding for Increased hygiene and performance Anti-Microbial Tubing Reducing Hospital-Acquired Infections Key Benefits Inhibits microbial growth No secondary operations such as coating Design flexibility Available for both standard and custom parts Hose Fittings Reducing assembly costs and improving application performance Key Benefits Maximum 15Ra mechanical finish Type 316 stainless steel Exceeds Class VI standards for internal smoothness and in compliance with 3A Fully seals off the transition from hose to fitting Interlock between crimp collar and insert fitting eliminates any possibility of fitting blow-off Unique barb configuration offers end-to-end fully sealed crimps Multi-lumen channels are separated into their individual lines by an over molded connector Co-Extruded Tubing Allowing multiple materials within the same tube Key Benefits Simultaneously extruded, providing similar integrity to standard tubing Accounts for differing material properties and media interactions Allows combinations such as silicone ID for compatibility with drugs, while having PVC exterior for better handling The Tubing and Hose Selector App simplifies selection of the correct tubing and hose, based on design parameters such as material and pressure. It provides the information instantly and eliminates the need to search through catalogs. The app also allows you to directly contact Trelleborg Sealing Solutions or request samples. The app is available for Android and ios. Just search for Tubing and Hose Selector in the App Store or Google Play. TRELLEBORG SEALING SOLUTIONS 17

18 CUSTOM PRODUCTS Custom Products Silicone Extrusion Tubing Tubing can be manufactured to custom specifications. Sizes can be down to 0.20mm x 0.35mm and tolerances as low as +/ mm. Bump tubing and formed tubing capabilities are also possible. Silicone tubing is made from medical grade HCR, platinum cured silicone. Multi-Lumen Tubing Multiple fluid or wire paths can be customized with a range of shapes and sizes. Dimensional tolerances are possible to +/ mm (0.001 inch). Multilumen tubing can be produced with a continuous twist at a selectable pitch for applications requiring improved column strength, strain relief and electrical noise reduction when threaded with wires. Bump tubing capabilities are also possible. Multilumen extrusions are made from medical grade HRC, platinum cured silicone. Silicone Foam Close cell silicone foam offers custom mechanical characteristics by lowering effective durometer and providing additional cushion space. Silicone foam extrusion can be customized in a variety of sizes and cross sections with precision tolerances; even pore size and foam density can be adjusted. Silicone foams are made from medical grade HCR, platinum-cured silicone. Reinforced / Kink Resistant Tubing (KRT): urology Silicone Tubes and hoses can be reinforced in a variety of options, from Polyester and stainless steel braids for expansion, elongation or burst resistance to spiral reinforcement with nylon monofilament for kink and crush resistance. Reinforcement is customizable and tubes can be made to precision tolerances. Reinforced tubes are made using medical grade HCR, platinum cured silicone. Extruded Ribbon Silicone tape, sheet or ribbon can be extruded up to 152 millimeters/6 inches in width and with a thickness down to 0.13mm (0.005 inches). Such ribbon can be supplied in spools with carriers and slip sheets or as punched seals or diaphragms. Extruded ribbons are made from medical grade HCR, platinum-cured silicone. 18 TRELLEBORG SEALING SOLUTIONS

19 CUSTOM PRODUCTS Wire and Cable Jacketing Wires and cable assemblies up to 5.08 millimeters/0.2 inches can be jacketed with one or more layers of silicone to precision tolerances. Such products can be supplied on spools or cut to length. Wires and cable assemblies are jacketed with medical grade HCR, platinum cured silicone. GeoTrans Geometric transitioning allows for silicone tubing to change cross section during the extrusion process to eliminate molding and secondary bonding steps, allowing for a hygenic design. The technology is applied to custom applications with precision tolerances. Typical changes include: changing of tube ID, OD or both to create a tube with two or more different cross sections, bifurcation or a dual lumen extrusion into two single lumen tubes, inclusion of channels to open internal fluid paths at locations along the extrusion length stopping one of multiple lumen to avoid backfilling, such as when the lumen will be used for balloon inflation. GeoTrans extrusions are made from medical grade HCR, platinum cured silicone. GeoTrans Extruded Balloons Silicone balloons are common to many medical devices. A preformed balloon segment is typically bonded to a catheter shaft at a position where a small opening allows inflation by saline or air. GeoTrans balloons are formed in a single extrusion step as an integral part of a catheter shaft eliminating significant costs associated with secondary operations and inspections. They can be produced in a range of sizes and inflation pressures to fit specific requirements. GeoTrans Single Lumen Our GeoTrans Single Lumen technology, also called Off-Ratio Bump Tubing creates two distinct tube cross sections with near-step transition between. Tubing lengths are available in single transition (cross section A to B) or double transition (cross section A to B to A). Applications include custom end assemblies, such as accommodation of connectors or fitting, and peristaltic pumps. TRELLEBORG SEALING SOLUTIONS 19

20 B R A ID ED S IL I C O NE H O S E S Braided Silicone Hoses 100 HP Series Platinum-Cured Single Ply Polyester Braid Reinforced USP Class VI Silicone Hose Features: High pressure ratings Excellent flexibility Sterilizable Autoclavable Imparts no taste or odor Available in bulk or assemblies Pigmented outer covers available Available in 25 ft, ft, and 100 ft lengths Temperature range: -80 F to +0 F /-62 C to +260 C Applications: Pumps, pharmaceutical processing, vessel or tank transfer, cell cultures, load cells Approvals: Meets USP Class VI, FDA, and USDA requirements Table 1: Braided Silicone Hose, 100 HP Series - Inch Hose Wall ID (in) Tolerance (in) (in) Recommended Working Pressure PSI at 68 F Min. Burst Pressure PSI at 68 F Min. Bend Radius (in) / / / Note: Sizes are those that are currently available. Contact your local Trelleborg Sealing Solutions marketing company for other sizes. 20 TRELLEBORG SEALING SOLUTIONS

21 B R A ID ED S IL I C O NE H O S E S 200 HP Series Platinum-Cured Double Ply Polyester Braid Reinforced USP Class VI Silicone Hose Features: High pressure ratings Excellent flexibility Sterilizable Autoclavable Imparts no taste or odor Available in bulk or assemblies Pigmented outer covers available Available in 25 foot lengths Temperature range: -80 F to +0 F /-62 C to +260 C Applications: Pumps, pharmaceutical processing, vessel or tank transfer, cell cultures, load cells Approvals: Meets USP Class VI, FDA, and USDA requirements Table 2: Braided Silicone Hose, 200 HP Serie - Inch Hose Wall ID (in) Tolerance (in) (in) Recommended Working Pressure PSI at 68 F Min. Burst Pressure PSI at 68 F Min. Bend Radius (in) / Note: Sizes are those that are currently available. Contact your local Trelleborg Sealing Solutions marketing company for other sizes. TRELLEBORG SEALING SOLUTIONS 21

22 WRAPPED HOSE Wrapped Hose Platinum-Cured Silicone Hose reinforced with Stainless Steel Wire & four layers of Polyester, USP Class VI Features: High pressure ratings No risk of collapse under negative pressure No swelling under high pressure Sterilizable Autoclavable Imparts no taste or odor Temperature range: -60 C to +170 C Four layers of Polyester plus Stainless Steel Wire Applications: High pressure and vacuum applications, pharmaceutical processing, food contact applications, vessel or tank transfer Approvals: Meets USP Class VI, FDA, German BGVV XVA & LIA, ISO sections 5,6,10,11, Italy Gazetta Ufficiale 1973, USDA Standards, European Pharmacopoeia 3.1.9, France Journal Officiel-Brochure 1227 Table 3: Wrapped Hose - Metric Hose Wall Bend Radius Burst Pressure Vacuum ID (mm) Tolerance (mm) +0 / / / / / (mm) (mm) (psi) (mm Hg) Note: Sizes are those that are currently available. Contact your local Trelleborg Sealing Solutions marketing company for other sizes. 22 TRELLEBORG SEALING SOLUTIONS

23 PREMIUM GRADE SILICONE TUBING Premium Grade Silicone Tubing Sanitary Hose Platinum-Cured Single Lumen (USP Class VI FDA) Masterfile Trelleborg Sealing Solutions offers a selection of materials that have been tested for implant greater than 29 days and are supported by masterfiles submitted to the FDA. Features & Benefits: Platinum-cured for a high degree of purity Extended post cure for lowest level extractables Biocompatible, inert, non-reactive with other elements per systemic testing Odorless, tasteless, non-toxic for use in medical, food, drug, personal care, and deionized water applications Non-leaching plasticizers Sterilizable by radiation, EtO, steam 30 psi at +253 F /+123 C for use in sterile applications, reusability Resists temperature extremes flexibility retention: -65 F to +400 F /-54 C to +204 C; brittlepoint: -100 F /-73 C Translucent for visual monitoring Color stripe, tint for custom process control identification Biocompatibility Tests: Tests conducted per the standards set by the United States Pharmacopoeia National Formulary, Class VI Biological Test for Plastics, and also conducted according to Ph Eur VI Material for long-term implants available Platinum-cured material meets or exceeds the requirements of these protocols. Testing Sample Results Per Standard Hemolysis Test 0.0% Heavy Metals as Lead None Detected Cell Culture Toxicity None Chromotropic Acid Test Complies Clarity of Solution Complies Acidity/Alkalinity Complies Substances Soluble in Hexane Complies Volatile Matter Complies Mineral Oils Complies Phenylated Compounds Complies Residual Peroxides Complies Platinum Complies Dichlorobenzoic Acid Residue None Detected HPLC analysis of IPa Extract Elastomer Physical Properties ASTM Method Typical Values Hardness Durometer A D Tensile strength psi D Elongation % D Tear Resistance Die B ppi D Compression set % (22 hours at +3 F) D TRELLEBORG SEALING SOLUTIONS 23

24 PL AT IN U M - C U RED S IN G L E LU MEN Platinum-Cured Single Lumen USP Class VI FDA Masterfile Additional services and features Furnished in custom lengths, bulk, or cut to length Multi lumen, radiopaque, striped, color coded available Custom sizes and standard sizes available Also available in peroxide cure Table 4: Platinum-Cured Single Lumen, Material: Silicone - Metric ID (mm) Tolerance* (mm) OD (mm) Tolerance* (mm) ID (mm) Tolerance* (mm) OD (mm) Tolerance* (mm) 1 +/ / / / / / / / ,5 +/ / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /-.400 Note: Sizes are those that are currently available. Contact your local Trelleborg Sealing Solutions marketing company for other sizes. *Tolerances to ISO 3302 E2 24 TRELLEBORG SEALING SOLUTIONS

25 PL AT IN U M - C U RED S IN G L E LU MEN Table 4: Platinum-Cured Single Lumen, Material: Silicone - Inch Hose Wall OD Standard Length Burst (ft) (psi) ID (in) Tolerance (in) (in) / / / / / / / / / / / / / / / / / / / / / / / / / / / / / , Note: Sizes are those that are currently available. Contact your local Trelleborg Sealing Solutions marketing company for other sizes. TRELLEBORG SEALING SOLUTIONS 25

26 SHEETING Elastomer Sheeting Trelleborg offers different kinds of elastomer sheeting material designed for applications demanding the ultimate compatibility in heathcare & medical and other biologically related applications. The sheeting comes in sizes up to 900 x 1800 millimeters and also materials punched, cut or molded to the final geometry. They can even be reinforced or supplied as very thin sheets. Our special capabilities: Silicone, EPDM and PTFE sheeting Silicone highly permeable to gases EPDM with low gas permeability Stability in sterilization Customizable to special geometries Customized packaging available Do you have specific requirements? Contact us! For details of your nearest Trelleborg Sealing Solutions marketing company go to Silicone Sheet Production Standard Sheeting Different silicone elastomer materials for demanding applications in a variety of thicknesses. Fabric-Reinforced Sheeting Fabric is embedded between one or two layers of silicone sheeting and can be reinforced with a variety of woven and mesh fabrics made from materials such as polyester and nylon. Unvulcanized reinforced sheets are made from a High Consistency Rubber (HCR) peroxide cure system and can be supplied punched or cut to length on a protective carrier and cover sheet. Vulcanized reinforced sheeting is made from Liquid Silicone Rubber (LSR) or HCR platinum-cured system, and can be supplied bulk spooled, punched, or cut to length on a protective carrier and cover sheet. 26 TRELLEBORG SEALING SOLUTIONS

27 SHEETING Micro Sheeting Custom silicone micro sheeting can be supplied in thicknesses as low as 0.08mm /0.002 inch in usable widths up to 8mm /20 inches. Micro sheeting is available vulcanized and can be supplied bulk-spooled, punched, or cut to length on a protective carrier and cover sheet. Micro sheeting is made from Liquid Silicone Rubber (LSR) or silicone dispersion. Gel Sheeting Custom gel sheeting can be provided with a low, medium, or high tack, ideal for applications such as scar and wound management. Gel sheeting can be supplied bulk spooled, or cut to length on a protective carrier and cover sheet. Gel sheeting is also offered coated on a layer of LSR sheeting or spandex fabric. Unvulcanized HCR Sheeting Customer silicone sheeting can be supplied in the uncured state for secondary assembly or molding operations. Unvulcanized sheets are made from High Consistency Rubber (HCR) peroxide cure system and are supplied cut to length as flat sheets to prevent distortion, or punched on a protective carrier. Vulcanized Sheeting Customer vulcanized silicone sheeting is made from Liquid Silicone Rubber (LSR) or High Consistency Rubber (HCR) platinum cure system. LSR sheeting can be supplied bulk spooled, punched, or cut to length on a protective carrier and cover sheet. HCR sheeting can be supplied punched, or cut to length on a protective carrier and cover sheet. EPDM Sheet Production Himod Flatseal EG A new series of EPDM FlatSeal that meets U.S. Pharmacopoeia (USP) Class VI certification. The new series meets the specific needs of pharmaceutical, medical and biotech equipment manufacturers who seek USP Class VI certified flat seals. PTFE Sheet Production Himod Flatseal 43 & 45 The HiMod flat gasket range consists of products that will satisfy the requirements of the majority of gasket applications. Suitable for food & pharmaceutical contact, the gaskets offer improved performance compared to conventional polytetrafluoroethylene (PTFE) flat gaskets. TRELLEBORG SEALING SOLUTIONS 27

28 Trelleborg is a world leader in engineered polymer solutions that seal, damp and protect critical applications in demanding environments. Its innovative solutions accelerate performance for customers in a sustainable way. Trelleborg Sealing Solutions is a leading developer, manufacturer and supplier of precision seals, bearings and custom-molded polymer components. It focuses on meeting the most demanding needs of aerospace, automotive and general industrial customers with innovative solutions. facebook.com/trelleborgsealingsolutions twitter.com/trelleborgseals youtube.com/trelleborgseals linkedin.com/company/trelleborg-sealing-solutions Copyright 2017 Trelleborg AB (publ). All rights reserved. Information and related materials are subject to change without notice. 99GBHFBROEE1117 If you d like to talk to Trelleborg Sealing Solutions, find your local contact at: