Your journey to the heart of our. silicone elastomer solutions

Transcription

1 Silicones Delivering your potential Mix&Fix CENTER Your journey to the heart of our Bluesil silicone elastomer solutions Silbione

2 General introduction What are silicones? From silicon metal to a full range of silicone elastomer solutions The term silicone is used to describe a variety of organosilicon compounds that integrate silicon, a chemical element designated as Si. Silicon cannot be found naturally in its pure state, but is present in chemically and thermally stable mineral compounds. The common term silicone refers to the chemical family of polyorganosiloxanes. In practice, the organic part of the polymer can be a methyl group, but other constituents can be seen on Si atoms. Main features of silicone: Heat stability to 200 C (which can be increased up to 300 C using specific additives) Exceptional aging resistance (even under extreme conditions) Great versatility in uses and applications Harmless due to the inorganic Si-O-Si chain 14 Si 2 3

3 General introduction Why choose silicone elastomers? Why choose? Macromolecules with unlimited structural possibilities Silicones (or polyorganosiloxanes) use a chemical structure based on alternating units of silicon and oxygen. The advantage of silicones, compared to natural silica, is that their organic content, based on carbon groups, is integrated into their molecular structure. According to the type of organic group attached in this way and the process conditions, silicones generate a wide variety of products. Their final form can be free flowing, viscous, paste-like, elastomeric or even rigid. A mineral-plastic hybrid The difference between silicones and other organic polymers (i.e. plastics) is that they contain a semi-inorganic element of silicon linked to oxygen atoms with Si-O bonds. The bonds formed between the silicon and oxygen atoms strengthen the macromolecular structure and are exceptionally stable and much more difficult to break than the carboncarbon bonds found in organic polymers. Stable high-performance polymers Silicones outperform most other polymers because of their remarkable spreading capability, coupled to their outstanding resistance to extreme temperatures, UV and IR radiation, as well as their ability to withstand aggression from a multitude of other external agents. This means that silicones clearly provide the highest levels of performance among polymers. A vast range of applications Thanks to their outstanding properties, silicone elastomers are used in many different industrial applications: pipes & hoses (automotive, medical and food), sealing (joints in construction and aeronautics, automotive gaskets) and electrical protection (construction safety cables, energy insulators, spark plug boots, cables and connectors for automotive applications). For food processing and pharmaceutical applications (tubes, profiles and gaskets), the Silbione range of elastomers is specially formulated to be safe for human contact and consumption, complying with the strictest regulations all over the world. When you choose, you work with a team of dedicated professionals, passionated about what they do, bringing you agile and innovative solutions that help in Delivering your Potential, as our corporate tagline states. With over 50 years of experience as a fully-integrated player and with a worldwide network of state-of-the-art facilities exclusively devoted to the silicone rubber market, we offer our customers the full range of Heat-Cured Rubbers, Liquid Silicones Rubbers, additives and customized compounds they need. Whether you need standard products or are looking for tailor-made solutions or services, we give you the opportunity to choose what is best suited to your needs! 0 Si 0 0 Si CH Si 3 CH 3 CH 3 CH 3 CH 3 CH 3 Dimethylsiloxane unit n Chemical structure 4 5

4 Silicones Our Mix & Fix Centers help you to develop your business How to facilitate your operations through our Mix & Fix Centers? Sharing your needs At, your challenges are ours as well. To respond more closely to your needs, our Mix & Fix Centers are located in the heart of major rubber and elastomer converting regions. We come to see you where you are and listen to your requirements, so that we can understand clearly what you re aiming for and how we can work together to achieve your goals. Enabling your solutions Specialized in heat-curing silicone rubbers, our Mix & Fix Centers develop quickly and efficiently products that are compatible with your production facilities and equipment. By operating locally, we develop solutions that meet your standards and contribute to achieving your Key Performance Indicators. To do that, we offer custom-designed and tailor-made compounds in the colors, packaging/ format and curing systems of your choice, with the best additives in the market. Delivering your potential Mix&Fix CENTER Mix & Fix Center, Tailor made silicone solution for you: ready to use, easy to process! Bluesil Silbione Succeeding together to build the future We believe that providing you with the best products available in the market is just the start. At, we go one step further to help you to deliver your potential, by anticipating on market needs, training your teams, sharing product stewardship and knowledge to improve your products and process integration. As a committed partner, we make sure we grow together and that we share a common vision, based on innovation and entrepreneurship. This is why we offer you all the services you need to get the most out of our products. 6 7

5 General introduction You benefit from all the services you need Get access to the entire value-chain of a fully integrated silicone manufacturer Human Ressources We help you to develop your team with: Specific training programs, studies, events... Strong relations with a dedicated team A solution-focused mindset. Supply Chain Make sure you have the quantities you need when you need them! Double supply-chain qualification Stock consignment or Kanban system Flexibility on orders, in particular for product launches Reprocessing service for materials beyond expiry dates. Business Performance Stay a step ahead of the competition through: Volume & price commitments Productivity improvements Different payment conditions Stable long-term contracts. Regulatory & Quality Differentiate your offer by supporting your customers in qualifying their products: Supply of required documentation and statements Quality support Regulatory advice Dedicated medical & food lines Certification assistance. Innovation Obtain recognition as an innovative partner by launching new solutions that you and your customers can count on: Co-development programs Access to our latest innovations Tailor-made solutions. From silicon metal to siloxane From siloxane to silicone & master batches Bluesil & Silbione : Serving a wide range of markets Mix&Fix CENTER From master batches to custom compounds They ve experienced it & testify Cables Construction Aerospace Healthcare We recruited two engineers to develop our business in silicones. supported us and provided us with three days of specific training. It s always better to learn from experts! Ever since I ve worked with, we have never missed a production slot thanks to the stock consignment they provide, enabling us to build a trusting relationship with our customers! They were the only supplier willing to split our initial orders under MOQ, to facilitate our production ramp-up. Their support made the difference and I ll never forget that! Automotive Food Railway Home appliances Fire protection 8 9

6 General introduction Access a full range of silicone elastomers for the rubber industry with a choice of numerous technologies 01. Bluesil Heat Cure Rubber Heat cure silicone elastomers are essentially made from reactive silicone gums and specific silica fillers. Bluesil Heat Cure Rubber products offer outstanding properties and are far superior to conventional organic elastomers. They provide exceptional mechanical strength at temperatures ranging from -50 C to +300 C. The aging resistance of these elastomers is based on fundamental features, including their chemical inertness, photo-oxidative stability and an absence of residual reactive groups once they are cured. Heat Cure Rubbers exist in a wide range of colors and are supplied in two formats: master batches (uncolored without incorporated catalysts) or as ready-to-use custom compounds through the network of Mix & Fix Centers. 03. Silbione Heat Cure Rubber 04. Liquid Silicone Rubber Silbione Liquid Silicone Rubbers are two-component systems in which viscosities are generally between 10 3 and approximately 10 6 mpa.s. This type of formulation forms an elastomeric network through polyaddition reactions in the presence of a platinum catalyst. The processing and product performance advantages of Liquid Silicone Rubber are useful in many existing processes and new applications. This type of rubber can combine key properties of silicone polymers for easy injection-mold processing. After mixing the A and B parts in a static or dynamic mixer, they are mainly used in injection-molding machines working at medium or high pressures or in pumps that directly feed molds at ambient pressure. These mixtures are vulcanizable from 80 C to 180 C. The Silbione brand offers a range of silicone elastomers dedicated to food contact, pharmaceutical and biomedical applications. Silbione Heat Cure Rubber and Liquid Silicone Rubber raw materials are manufactured and controlled to meet specific process protocols. The Silbione range of elastomers all comply with existing regulations (positive lists) Bluesil Polyaddition Heat Cure Rubber Bluesil Polyaddition Heat Cure Rubber is a range of platinum-catalyzed silicones. The polyaddition crosslinking reaction is much faster than the one initiated by peroxides, which improves productivity and does not generate any toxic by-products. They feature an excellent combination of mechanical properties, while respecting the environment and improving working conditions. Bluesil Polyaddition Heat Cure Rubber is easily processed, adapted to the mold and injection presses widely used in the rubber industry, and therefore avoid you having to make further investments. 05. Additives & Colors Additives: can be used in all Heat Cure Rubber master batches and are distributed in two categories: process-enhancing additives and performance-enhancing additives. Ready-to-use: are available in a wide panel of colors. 11

7 12 13

8 01 Bluesil Heat Cure Rubber 01 Bluesil Heat Cure Rubber general purpose products markets a wide variety of Heat Cure Silicone Rubbers (HCR) under the Bluesil brand name. The properties of this general-purpose series are based on an excellent compromise of features for a wide range of applications, with exceptionally easy to process products, offering optimized performance when converted. Advantages of Bluesil HCR general-purpose products The keys to continuous performance improvement: Heat stability in continuous use from -50 to +200 C (can be increased to 300 C and beyond using specific additives) Exceptional resistance to aging (even under extreme conditions). Manufacture the materials you dream of with great flexibility of use: Vast possibilities for blending with other Bluesil HCR products Easy pigmentation using Color Master batches for HCR products Easy to extend with silica fillers (quartz type) Availability of a wide range of processing and performance-enhancing additives (plasticity adjustment, improved fire resistance, ash cohesion, etc.). Mix & Fix Center helps you transform your ideas into solutions. We customize products that meet your performance criteria, with packaging adapted to your processes and supply-chain needs, enabling you to best serve your markets. Profiles Ignition sets Jump into your silicone elastomer solutions Molded technical parts Silicone rubber rollers Insulators Construction profiles 14 Automotive hoses 15

9 01 Bluesil Heat Cure Rubber Bluesil General-purpose products Series 100 Series 200 Series 300 Calendering / Extrusion / Molding Calendering / Molding Calendering / Extrusion / Molding High transparency Good compromise of properties No postcure Low compression set / high resiliency High transparency High tear strength General characteristics Mechanical properties after cure Properties Standards Units MF 135 U MF 155 USP MF 160 USP MF 175 USP MF 180 U MM 750 U MM 760 U MF 345 U MF 360 U MF 370 U Appearance Transparent Transparent Transparent Transparent Transparent Transparent Translucent Transparent Transparent Transparent Specific gravity ISO 2781 (g/cm 3 ) Heat stability 200 C 200 C 200 C 200 C 200 C 200 C 225 C 200 C 200 C 200 C Catalyst type E E E E E E L E L E L E L E L Catalyst content (parts) Post cure No 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C No 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C Hardness shore A ASTM D Tensile strength ISO R37 (MPa) Elongation at break ISO R37 (%) Secant modulus at 100% elongation ASTM D 412 (MPa) Tear strength ASTM D 624 A (kn/m) Compression set (22 h/177 C/25%) ISO (%) Rebound resilience ISO 4662 (%) Series 900 Series 900 Calendering / Extrusion / Molding Calendering / Extrusion / Molding General characteristics Mechanical properties after cure Translucent Excellent compromise between resiliency compression set and tear strength Translucent - Excellent compromise between resiliency compression set and tear strength Properties Standards Units MF 940 U MF 950 USP MF 960 U MF 970 USP MF 980 U Appearance Translucent Translucent Transparent Translucent Translucent Specific gravity ISO 2781 (g/cm 3 ) Heat stability 225 C 200 C 200 C 225 C 200 C Catalyst type E L E L E L E L E L Catalyst content (parts) Post cure 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C Hardness shore A ASTM D Tensile strength ISO R37 (MPa) Elongation at break ISO R37 (%) Secant modulus at 100% elongation ASTM D 412 (MPa) Tear strength ASTM D 624 A (kn/m) Compression set (22 h/177 C/25%) ISO (%) Rebound resilience ISO 4662 (%) Catalyst Name Vulcanizing technique 2,4 dichlorobenzoyl peroxide 2,5-Dimethyl-2,5-di (tert-butylperoxyl) hexane Dicumyl peroxide E L D Without hot air pressure or infrared extrusion Melted salt bath extrusion Extrusion in steam at 12 to 20 bars pressure Molding Extrusion in steam at 6 to 12 bars pressure Molding 16 ** Properties measured on 2 mm ASTM compression molded specimens Cure Time: - Cata E, 8 min 115 C - Cata L, 10 min 170 C 17

10 01 Bluesil Heat Cure Rubber Bluesil Heat Cure Rubber Specialty products markets Bluesil Heat Cure Rubber Specialty products designed to withstand extreme processing and operational conditions. Providing the highest performance levels, these products are specially designed for the most demanding applications. Advantages of Bluesil Heat Cure Rubber Specialty products Special products for special needs Easy processing Outstanding oil resistance Very high heat stability Excellent damping coefficients Very low shore hardness and extrusion capabilities Coolant fluid resistance Low compression set. For specific markets with demanding regulations, provides you with product stewardship support to facilitate your customer approvals. General characteristics Mechanical properties after cure THT series Molding / Extrusion Very high stability, up to 300 C Properties Standards Units MM 40 THT MM 50 THT HD 1070 U MM 70 THT Appearance Creamy white Creamy white Creamy white Creamy white Specific gravity ISO 2781 (g/cm 3 ) Heat stability 300 C 300 C 300 C 300 C Catalyst type E L E L E L E L Catalyst content (parts) Post cure 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C Hardness shore A ASTM D Tensile strength ISO R37 (MPa) Elongation at break ISO R37 (%) Secant modulus at 100% elongation ASTM D 412 (MPa) Tear strength ASTM D 624 A (kn/m) Compression set (22 h/177 C/25%) ISO (%) Rebound resilience ISO 4662 (%) Oven profiles General characteristics Molding Excellent damping coefficient Resistance to low temperature Properties Standards Units MM 771/30 U MM 771/50 U MM 771/80 U Appearance Translucent Translucent Translucent Specific gravity ISO 2781 (g/cm 3 ) Heat stability C to 250 C C to 250 C C to 250 C Mechanical properties after cure Catalyst type E L E L E L Catalyst content (parts) Post cure 16 hours at 200 C 16 hours at 200 C 16 hours at 200 C Hardness shore A ASTM D Aeronautics Tensile strength ISO R37 (MPa) Elongation at break ISO R37 (%) Gasketing and O-rings Automotive cables Cables Secant modulus at 100% elongation ASTM D 412 (MPa) Tear strength ASTM D 624 A (kn/m) Compression set (22 h/177 C/25%) ISO (%) Rebound resilience ISO 4662 (%) ** Properties measured on 2 mm ASTM compression molded specimens 18 Safety cables Cure Time: - Cata E, 8 min 115 C - Cata L, 10 min 170 C 19

11 01 Bluesil Heat Cure Rubber Bluesil Heat Cure Rubber Specialty products Molding / Extrusion Low hardness Molding / Extrusion / Calendering High tear strength, low compression set Good heat stability General characteristics Mechanical properties after cure Properties Standards Units MF 120 SU MF 25 U HD 1060 U HD 1070 U Appearance Translucent, coulourless Beige Creamy white Creamy white Specific gravity ISO 2781 (g/cm 3 ) Heat stability 200 C 225 C 250 C 250 C Catalyst type E L E E L E L Catalyst content (parts) Post cure 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C Hardness shore A ASTM D Tensile strength ISO R37 (MPa) Elongation at break ISO R37 (%) Secant modulus at 100% elongation ASTM D 412 (MPa) Tear strength ASTM D 624 A (kn/m) Compression set (22 h/177 C/25%) ISO (%) Rebound resilience ISO 4662 (%) Series 600 Series 700 Molding / Extrusion Translucent elastomer Excellent processing properties Good compromise tear strength and compression set Molding / Calendering Coolant fluid resistance High resiliency - Very good processability General characteristics Mechanical properties after cure Properties Standards Units MF 620 U MF 660 U MF 670 U MF 680 U MM 750 U MM 760 U MM 770 U Appearance Translucent Translucent Translucent Translucent Translucent Translucent Translucent Specific gravity ISO 2781 (g/cm 3 ) Heat stability 200 C 200 C 200 C 200 C 225 C 225 C 200 C Catalyst type E L E L E L E L E L E L E L Catalyst content (parts) Post cure Whithout post cure Whithout post cure Whithout post cure Whithout post cure 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C Hardness shore A ASTM D Tensile strength ISO R37 (MPa) Elongation at break ISO R37 (%) Secant modulus at 100% elongation ASTM D 412 (MPa) Tear strength ASTM D 624 A (kn/m) Compression set (22 h/177 C/25%) ISO (%) Rebound resilience ISO 4662 (%) Catalyst Name Vulcanizing technique 2,4 dichlorobenzoyl peroxide 2,5-Dimethyl-2,5-di (tert-butylperoxyl) hexane Dicumyl peroxide E L D Without pressure hot air or infra red extrusion Melted salt bath extrusion Extrusion in steam at 12 to 20 bars pressure Molding Extrusion in steam at 6 to 12 bars pressure Molding 20 21

12 02 Bluesil Polyaddition Heat Cure Rubber 02 Bluesil Polyaddition FIM and HCRA Constantly at the forefront of innovation, offers its customers a full range of platinum-catalyzed silicones (polyaddition reaction): Bluesil Polyaddition FIM (Fast-Cure Injection Molding) can be easily processed in the mold and injection presses currently used in the rubber industry, without generating further investments. Bluesil Polyaddition HCRA (for extrusion and calendering) can be easily processed in the standard rubber industry equipment, without generating further investments. Advantages of Bluesil Polyaddition Heat Cure Rubber Increase your injection molding process productivity Cure kinetics 2 to 3 times quicker than peroxide grades. Choose outstanding processing capabilities with 1, 2 or 4 components: you decide! Excellent demolding (no surface tack) and extrusion processing Significant reduction in reject rates very good tear strength at high temperatures, with curing relatively unaffected by temperature uniformity (complex molds, multi-cavity molds, thick-section parts, etc.). Add very good mechanical properties Excellent compromise between elongation at break / tear strength / compression set. Prefer low-temperature curing Energy savings. Respect the environment and improve working conditions Free of peroxide residues Odorless vulcanizing. Food processing Jump into your silicone elastomer solutions Conveyor belts Tubing 22 Medical processing 23

13 02 Bluesil Polyaddition Heat Cure Rubber Bluesil Polyaddition FIM and HCRA For fast injection molding General characteristics Mechanical properties after cure * Properties measured a 2 mm ASTM compression molded specimens. Cure Time: 5 min at 170 C For extrusion Excellent processability Outstanding cure rate Good general compromise of properties Low compression set and high resilience General use Excellent processability Outstanding cure rate Good compromise of properties: High tear strength High elongation at break High performance Properties Standards Units FIM 5125 FIM 5145 FIM 5160 FIM 5170 FIM 5340 FIM 5360 FIM 5375 Appearance Transparent Translucent Translucent Translucent Transparent Transparent Transparent Specific gravity ISO 2781 (g/cm 3 ) Post cure No 4 hours at 200 C No 4 hours at 200 C No Hardness shore A ASTM D Tensile strength ISO R37 (MPa) Elongation at break ISO R37 (%) Tear strength ASTM D 624 A (kn/m) Compression set (22 h/177 C/25%) 4 hours at 200 C ISO (%) Rebound resilience ISO 4662 (%) No 4 hours at 200 C No 4 hours at 200 C No 4 hours at 200 C No 4 hours at 200 C To offer you flexibility in your processing, supplies you with Bluesil Polyaddition HCR products, delivered as ready-mixed compounds from its Mix & Fix Center. These products are available in 1, 2 or 4 components. We work with you to define which compounds are most cost effective and best suited to your processing conditions, to achieve the performance levels you require. We closely analyse your requirements so that our Mix & Fix Center can propose tailored formulations that meet your needs in terms of: Cost Finding the most cost-effective solution. Processing Optimization of the curing system by selecting the best compromise between productivity and processing constraints Specific performance criteria for each production unit. Performance Ready-mixed compounds supplied within the best lead times Analytical reports on production characteristics and targeted performance levels as a function of specifications and special requirements, advice on dedicated testing laboratories, etc. Mix & Fix Center prepares samples for approval and delivers special ready-mixed products, in line with your lead times and scheduling practices. Mix & Fix Center works in collaboration with rubber processing companies and their design & engineering departments, R&D centers and materials testing facilities. HCRA 135 A&B HCRA 155 A&B HCRA 160 A&B HCRA 175 A&B Hardness, Shore A Tensile strength (MPa) Elongation at Break, % Compression set, % Rebound resilience, %

14 03 03 Complying manufactures and markets the Silbione Heat Cure Rubber series, a full range of materials specifically designed for: Food contact applications Medical devices. Silbione series HCRs are silicone master batches offering benefits for both industrial processors and end users. The Silbione brand offers you product performance and useful services to facilitate your operations and satisfy your customers, including the supply of documentation and certifications required for your critical applications. Silbione Heat Cure Rubber Silbione Heat Cure Rubber for food contact and medical devices with legislation and regulations Supporting you Silbione products offer optimal performance features: Excellent processing characteristics, based on short curing time Full compliance with national and international regulations. Food contact provides its customers, on demand, with: Compliance certificates, including tests for pharmaceutical applications Reports on biological testing for healthcare applications. Jump into your silicone elastomer solutions To satisfy your end-users Silbione formulations offer all the features needed for products fit for human consumption: Harmless due to the inorganic Si-O-Si chain High level of transparency for ease of use Suitable compositions, including the use of compounds that do not affect taste Absence of nitrosamines either in the elastomer or in the initial compound Excellent mechanical characteristics for improving performance Outstanding physical and chemical stability features: - A wide temperature range (-50 C C) - Outstanding resistance to thermal aging and oxidizing agents (oxygen, ozone, UV) - Excellent behavior when sterilized for safety reasons. Tubing for fluid handling Medical device components 26 27

15 03 Silbione Heat Cure Rubber Silbione Heat Cure Rubber High transparency High transparency High tear strength General characteristics Mechanical properties after curing and post-curing 4 hours at 200 C* Properties Standards Units MM USP MM 71791/40 U MM 71791/60 U MM 71791/70 U Appearance Transparent Transparent Transparent Transparent Specific gravity ISO 2781 (g/cm 3 ) Catalyst type E E E E Catalyst content (part) Post cure 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C 4 hours at 200 C Hardness shore A ASTM D Tensile strength ISO R37 (MPa) Elongation at break ISO R37 (%) Tear strength ASTM D 624 A (kn/m) Compression set (22 h/177 C/25%) ISO (%) Rebound resilience ISO 4662 (%) A perfect match between characteristics and applications Safe and biocompatible By carefully selecting the components that go into Silbione HCRs, we contribute to making sure that end products comply with the criteria defined in the pharmacopoeia, when processed under the proper conditions. These end products can meet biocompatibility criteria generally applied to silicone elastomer parts: Absence of hemolysis Absence of tissue and bacterial adhesion. Silicones comply with these requirements because they produce non-polar surfaces that radically reduce interaction with biological systems. High level of transparency Silbione HCRs achieve high levels of transparency because their components feature very high levels of purity, thus enabling conveyed liquids to be visualized and monitored efficiently. Absence of nitrosamines High transparency, combined with the absence of nitrosamines in Silbione HCR master batches, means that formulations are ideally suited to producing articles for infant applications (baby bottle teats, pacifiers, toys, etc.). Short post-curing time Due to the low volatile content of Silbione HCR master batches, end products comply with the strictest regulations, after short post-curing cycles (generally 4 hours at 200 C). The recommended minimum amount of air is 100 liters per minute and per kg of rubber. Excellent mechanical characteristics The mechanical characteristics of Silbione series HCRs are particularly well suited to specific uses: High tear and tensile strength that are essential for infant applications High resilience for drain and catheter applications and peristaltic pump accessories. For more information about performance and regulation compliance features, please get in touch with your local contact. Excellent physicochemical stability Silbione series HCR offer remarkable physicochemical stability: Wide range of uses in varying temperatures (-50 C to +200 C) Excellent resistance to: - Thermal aging - Oxidizing agents (oxygen, ozone, UV) Very good behavior when subjected to sterilization methods. The elastomers obtained when processed with Silbione HCR series master batches can withstand all current sterilization methods (autoclave, ethylene oxide, ionizing radiation) over several cycles or at high radiation levels without significantly varying their characteristics. Even under extreme sterilizing conditions, these elastomers comply with the physicochemical tests in European Pharmacopoeia (cf. Silicone Elastomers for fastenings and tubing applications 3.1.9, 1997). In all cases, the manufacturer of the finished product is responsible for checking compliance, using tests stipulated in the appropriate regulations. The use of these elastomers is prohibited for the following medical applications: Implanted devices for more than 29 days All devices in contact for more than 29 days with blood and mucus membranes (contraception, obstetrics) Plastic surgery. % Hexane soluble substances % Elongation at break nb cycle or 1 kgy dose 25 nb cycle or kgy dose ethylene oxide autoclave ionising radiation Type of sterilization Type of sterilization Sterilization effects 28 29

16 03 Silbione Heat Cure Rubber Quality assured Manufacturing takes special care to ensure the highest levels of manufacturing and quality control, in order to guarantee that its range of elastomers corresponds to user needs and complies with the special requirements of each application. This includes: Absence of cross-contamination High levels of filtration Specific testing protocols and processes. These actions are an integral part of the quality policy, which is ISO 9001 certified. Testing Specific testing is carried out on each batch of products in the Silbione HCR series to comply with applicable regulations. These results, as well as the description of the product s mechanical properties, are supplied with the analytical certificate delivered to our customers. Vulcanized, post cure product Aqueous extract Pharmacopoeia specification Medical grade Identity: IR Spectrum Conformity Volatile content (%): (200 C - 10 g- 4 hrs) 0.5 max Residual peroxides (%) 0.08 max Mineral oils (fluorescence) Conformity Turbidity (NTU) 4 max Alkalinity (ml HCI 0.01N) 1 max Acidity (ml NaOH 0.01N) 1.5 max Reduc. sub. (ml Na 2 SO N) 1 max Hexane extract Hexane soluble (%) 3 max Phenyl compounds (DO/UV) 0.4 max Heavy metals (ppm) (other liquid extracts) 10 max Complying with food contact and biomedical legislation In addition to tests performed on each batch, in line with European Pharmacopoeia stipulations, Silbione HCR master batches are subjected to tests directly related to their applications: formulation after catalysis, curing and post-curing for 4 hours at 200 C, etc. Food contact / migration tests Tests for aqueous and fat-rich environments are carried out according to regulatory obligations: EC Directive 82/711 and EC Directive 93/8 FDA: CFR 21, section The statements of compliance are issued on the basis of results required in these protocols and are available on request. Biological tests / biomedical applications The tests required for skin contact applications are carried out in accordance with EC Directive 93/42 dated June 14, 1993 for medical devices: Cytotoxicity Skin irritation Sensitization. For wound dressings, invasive devices, shortterm implants and blood contact applications, additional tests are carried out for certain Silbione EVC master batches according to ISO and USP class VI requirements: Acute systemic toxicity Intracutaneous toxicity Implantation study Hemolysis Pyrogenicity

17 04 Silbione Liquid Silicone Rubber 04 Silbione Liquid Silicone Rubber for food contact, pharmaceutical contact and healthcare applications The Silbione LSR range is specifically designed for pharmaceutical and healthcare applications, integrating fully biocompatible silicones that produce non-polar surfaces, radically reducing interaction with biological systems. The high level of clarity of Silbione LSR silicones and their mechanical properties are particularly well suited for making transparent molded parts such as baby nipples, pacifiers, stoppers and valves. These grades provide excellent resistance to standard sterilization technologies. Baby nipples Jump into your silicone elastomer solutions The benefits of Silbione LSR Principal properties Very high physical stability in a wide range of temperatures (-50 C to 200 C) Excellent resistance to thermal aging and oxidizing agents (oxygen, ozone, UV) Excellent resistance in sterilization Very high levels of transparency Biocompatibility Non-toxic residues or byproducts Well-suited mechanical properties. Product features to facilitate processing Automatic injection molding processes similar to standard thermoplastic injection molding Higher curing rate than other rubber grades with low scrap levels Highly productive cycle times without the need to scorch Easy demolding with good hot tear High levels of transparency and, when required, easy pigmentation. Kitchenware 32 Sport and leisure goods 33

18 04 Silbione Liquid Silicone Rubber Silbione Liquid Silicone Rubber General characteristics Mechanical properties after post-curing 4 hours at 200 C Properties Standards Units LSR 4301 A/B LSR 4305 A/B LSR 4310 A/B Appearance Transparency Transparency Transparency Specific gravity at 25 C ISO R1183 (g/cm 3 ) Viscosity (shear rate 1 s-1) (Pa.s) Viscosity (shear rate 10 s-1) (Pa.s) Pot life at 25 C days > 3 > 3 > 3 Hardness shore A ASTM D Tensile strength NFT (MPa) Elongation at break NFT (%) Compression set ASTM D 624 B (kn/m) Rebound resilience ASTM D 395 B (%) Rebound resilience ISO 4662 (%) LSR 4330 A/B LSR 4340 A/B LSR 4350 A/B LSR 4360 A/B LSR 4370 A/B Transparency Transparency Transparency Transparency Transparency > 3 > 3 > 3 > 3 > The Silbione LSR series of products features excellent properties and ease of processing The following tests are conducted on our Silbione LSR materials Product FDA 21 CFR A Cytotoxicity A USP Class VI B FDA Nitrosamines C Silbione LSR 4330 A/B OK (1) OK (1) Silbione LSR 4340 A/B OK (1) OK (1) OK (1) (3) OK (1) Silbione LSR 4350 A/B OK (1) OK (1) OK (1) OK (1) Silbione LSR 4360 A/B OK (2) OK (1) OK (2) OK (2) Silbione LSR 4370 A/B OK (2) OK (1) OK (1) (4) OK (2) A. Water and hexane extract tests conducted on final products (A+B). B. Tests conducted on final products (A+B), including sensitization, intracutaneous toxicity, systemic toxicity, muscle implant, & genotoxicity. C. Total nitrosamines tested on final products (A+B). OK (1). The test was carried out on the materials and was successfully passed. OK (2). The test was not carried out on the materials. However, it provided results substantially equivalent to another test on LSR materials. Test results are adequate for subject material. OK (3). Additional tests were carried out and successfully passed, including pyrogenicity and hemocompatibility. OK (4). Additional tests carried out and successfully passed, including pyrogenicity. Complying with regulations The Silbione LSR 4300 series of products can be used for food contact, pharmaceutical contact and healthcare applications. Due to the low volatile content of Silbione LSR formulations, these products comply with legislative and regulatory requirements after short post-curing cycles such as 4 hours at 200 C. The recommended minimum amount of air is 100 liters per minute per kg of rubber. Food contact The substances contained in Silbione LSR grade elastomers after curing and post-curing for 4 hours at 200 C comply with the following requirements: USA: FDA - code of Federal Regulation 21 - Chapt and FDA Nitrosamines Germany: BFR Part XV Silicones France: Journal Officiel dated Nov. 25, brochure Healthcare The Silbione LSR 4300 series of products is formulated to meet USP class VI and/ or ISO requirements for healthcare applications (see attached tables). Certified quality takes special care to ensure the highest levels of manufacturing and quality control. production locations are certified ISO In all cases, the manufacturer of the finished product is responsible for checking compliance, using tests stipulated in the appropriate regulations. The use of these elastomers is prohibited for the following medical applications: Implanted devices for more than 29 days All devices in contact for more than 29 days with blood and mucus membranes (contraception, obstetrics) Plastic surgery

19 05 Bluesil Additives & Color Master batches 05 Additives Bluesil Objective AD 717 Improve operation with extending fillers and plasticity adjustment AD 904 Increases green Strength DA 22 Improves demolding operation Mix & Fix Centers offer a wide range of processing and performance enhancing additives, as well as ready-to-use blends with optimized characteristics and performance levels. For more information concerning product performance and compliance with regulations, please get in touch with your local Elkem Silicones contact. Bluesil AD 916 AD 720 HFR 1 HAC 5 AD 744 Additives Objective Prevents blooming in non-post cured parts vulcanized with 2,4 dichlorobenzoyl peroxide (acid acceptor) Improves hot oil resistance Improves fire resistance (translucent versions) Improves ash cohesion and fire resistance Increases heat stability up to 250 C, industrial applications TFC 5 Increases heat stability up to 250 C AD 703 Increases heat stability up to 300 C, industrial applications TFC 10 Increases heat stability up to 300 C Bluesil Additives & Color A range of additives is available for Bluesil master batch users who blend their own compounds. Jump into your silicone elastomer solutions 36 37

20 05 Color Master batches Color Master batches for Bluesil HCR are quality products optimized for pigmenting silicone heat cure elastomers for technical or aesthetic reasons. High-level and cost-effective pigmentation Optimized consistency, enabling fast addition of colors on a two-roll mill To obtain the best mix, it is advised to add the Color Master batches after the curing agent and any other additives have been incorporated. ref. RAL equiv. White MB Yellow MB Brick Red MB /3016 Dark Red MB Dark Blue MB Brown MB /8016 Recommended levels and colors Recommended levels: 1.2 % for most Color Master batches, but 0.4 to 0.5 % is sufficient for grey and black. The levels recommended above provide the shade of color in ASTM slabs using Bluesil TM MF 175 USP catalyzed with 2,5 -dimethyl -2,5 di (tert-butylperoxy) hexane, cured for 10 minutes at 170 C and post-cured 4 hours at 200 C. Quality and consistency of the colors Colors are tuned by trichromatic spectrometry to minimize the variation of shades between batches. Green MB Grey MB /7000 Ox Black MB Black MB

21 Silicones Delivering your potential is one of the world s leading fully integrated silicone manufacturers with applications and research laboratories, production sites and sales offices located around the globe. At, we re more than just high quality silicone products and associated services. We are a team of professionals located around the globe ready to provide you with the service and performance you deserve with a personal touch. From technical support to customized formulations and regulatory support, has the people in place when and where you need them, committed to help you deliver your potential. Because we care! The information contained in this document is given in good faith based on our current knowledge. It is only an indication and is in no way binding, particularly as regards infringement of or prejudice to third party rights through the use of our products. guarantees that its products comply with its sales specifications. This information must on no account be used as a substitute for necessary prior tests which alone can ensure that a product is suitable for given use. Determination of the suitability of product for the uses and applications contemplated by users and others shall be the sole responsibility of users. Users are responsible for ensuring compliance with local legislation and for obtaining the necessary certifications and authorizations. Users are requested to check that they are in possession of the latest version of this document and is at their disposal to supply any additional information. For detailed commercial contacts please visit our website: SIL France SAS 21, avenue Georges Pompidou F Lyon Cedex 03 - France Tel: +33 (0) Fax: +33 (0) Art direction & graphic design: Day on mars Font: Gotham Narrow Photography: Stephane Cande, Sebastien Secchi, Christian Chaize Image bank: GettyImages, Fotolia, Shutterstock, Fotosearch, istock.