The Silbione difference

Transcription

1 Silicones Delivering your potential Silbione The Silbione difference Medical grade Silicones for Healthcare & Biomedical applications 1

2 2 Silbione medicalgrade silicones designed specifically for healthcare & biomedical applications

3 Elkem Silicones General Introduction Elkem Silicones is a leading fully integrated global silicone supplier with more than 60 years of silicones formulation and manufacturing expertise. With manufacturing sites strategically located around the world, we combine upstream silicon metalloid operations, with downstream silicone formulation and application development expertise. This vertical integration allows us to offer a diverse range of silicone technologies to support a variety of specialty markets such as healthcare, paper release, textile coatings, moldmaking, automotive, aerospace, and personal care. At Elkem Silicones, we are dedicated people located around the globe, committed to your success. Whether you are looking for technical support, for customized formulations, or for biocompatibility support, we have the people in place when and where you want them. Designed specifically for the global healthcare market, our Silbione brand means you can count on the highest quality medical silicone solutions, produced in a clean environment, and supported by biocompatibility testing to meet your application needs. Whether for short term or long term implant applications, Silbione can provide solutions to meet your healthcare product needs. Why Silicones for Healthcare? Silbione brand silicones are increasingly used in healthcare and biomedical applications as a result of their biocompatibility, chemical inertness, hypoallergenicity, high performance physical properties and stability across a wide range of environmental conditions. Additional benefits may include: Sterilizable Bacterial resistance Phtalate-free BPA-free BSE-free Strong and durable Flexible Realistic skin feel Stable Lubricating properties 3

4 Biocompatibility and Regulatory support At Elkem Silicones, we believe in the safety and efficacy of our silicone products for healthcare and biomedical applications. Our medical Silbione products have been tested to meet US FDA, USP Class VI and ISO requirements. Products from the Silbione Biomedical range are supported by a Master Access File (MAF) on file with the FDA s Center for Devices and Radiological Health (CRDH) or by a Drug Master File (DMF) submitted to the FDA s Center for Drug Evaluation and Research (CDER). Our Regulatory Support Team is available to support customers with biocompatibility needs, either directly by providing them product attestations and toxicological summaries, or by supplying information to regulatory agencies in support of their medical device submissions (510k, IDE, CE Mark and PMA filings). As part of our commitment to Product Stewardship, we provide regularly updated guidelines related to the use of our silicone products in healthcare & biomedical applications: We do not support the use of our industrial grade Bluesil TM products for applications where silicone is in contact with healthcare patients. The healthcare range of medical Silbione silicone products have been validated to be biologically compatible for skin contact, scar care, skin care, ortheses, prostheses, dental applications and in specific cases for short-term (less than 29 days) implant applications, as well as wound management. Our Silbione Biomedical grade solid cured silicone elastomers have been tested to USP Class VI and ISO standards in support of long-term (30 days or more) healthcare and implant devices. We are continuously updating and upgrading our standards in order to comply with evolving market demands. To know more about the applications where we currently do not support the use of any of our Silbione and Silbione Biomedical grade silicone products, please contact your local Elkem Silicones representative. While we may provide formulation recommendations and processing assistance in support of our products, we would like to remind you that it is the sole responsibility of the component or device manufacturer to select a particular Elkem Silicones Silbione or Silbione Biomedical silicone product and determine its suitability for an application. 4

5 Elkem Silicones General Introduction Manufacturing In addition to biocompatibility testing and regulatory support, the quality of raw materials and manufacturing conditions differentiate medical grades from industrial ones. Being a fully integrated silicone supplier, we use raw materials with consistent origin, purity, and quality for our medical Silbione range. We also continue to invest in clean manufacturing operations to address our continuous improvement process focused on product safety and changing regulatory requirements. We manufacture Silbione medical grade in our downtream facilities in York (South Carolina, USA), Caronno (Italy), Lübeck (Germany) and Shanghai (China), which provide clean-room manufacturing in an ISO certified facility in each geographical zone. They all benefit from automatic bar-code traceability of raw materials and key process steps, resulting in state-of-the-art process control. We manufacture Silbione Biomedical long term implant-grade silicones in our new m 2 facility in York. These grades are manufactured in ISO 8 and packaged in ISO 7 clean room, using a dedicated Elkem Silicones Quality Management System which follows GMP principles and ISO guidelines. Combined with our upstream industrial footprint, they provide to our customers unparalleled peace of mind by the flexibility of their service, by ensuring double-sourcing of raw materials, by providing back-up manufacturing solutions, and by ensuring that Management Of Change is used to ensure that safety, health and environmental risks are controlled whenever we update our facilities, documentation, personnel, or operations. 5

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8 8 Silbione soft silicones: When comfort meets durability

9 Elkem Silicones Comfort Care, Orthotics & Prosthetics Silbione soft elastomers: when comfort meets durability Elkem Silicones is a global leader in soft silicone technologies: from low density gels for external breast forms to high elongation silicone rubber for durable liners for amputees; through easily pourable RTVs for orthotics and even silicone foams, we offer an extended choice of material for designers and manufacturers at the service of the patient s comfort. The combination of Silbione certification following the ISO standard and the hydrophobic nature of silicone will ensure the perfect compatibility of the prosthesis with skin. Their damping properties and realistic skin-like feel make them ideal for devices such as artificial limbs or pressure-relief cushions. Breat prosthesis Regulatory compliance Productivity Shoe insole Foam Skin friendly Comfort Purity Orthotics Prosthetic Liner Softness Pressure management Gels High elongation Lightweight Durability Realistic feel Biocompatible RTV Silicone Cushion Expertise Resistant to tear LSR Hydrophobic Easy processing Purity Realistic feel Prostectic liner Cushioning Foot care Breast forms 9

10 Medical Devices & Infant Care Silbione medical grade silicones for trouble-free manufacturing with high performance physical properties. Product Range We offer a complete range of medical grade silicones including: Liquid Silicone Rubber (LSR) Designed for Liquid Injection Molding (LIM) High Consistency Rubber (HCR) - Also referred to as Heat Cured Rubber, these are suitable for extrusion, compression molding, and transfer molding processes Room Temperature Vulcanized (RTV) Utilized in low temperature molding or casting applications Silicone Adhesives Designed to be used in medical device assembly Foams Room temperature curing low density open cell foams Specialty Fluids Coatings to help improve lubricity and reduce coefficient of friction Dispersions - Formulated for dip molding or coating applications Biocompatibility & Regulatory Support Attestations Toxicological Summaries Support with FDA (510K) EU Regulatory Bodies (CE Mark) Wearable devices Septums & Stoppers Balloons Pharmaceutical Tubing Catheters Coatings Sleep Apnea Masks Peristaltic Pump Tubing 10 Valves check, one-way, hemostasis, duck-bill, needle-free Baby Bottle Nipples & Pacifiers

11 Elkem Silicones Implantable and Drug Delivery Devices Silbione Biomedical Grade silicone materials are designed and manufactured to meet the strict regulatory, quality, and purity requirements of the long term implant ( 30 days in the body) and drug delivery markets. Quality and Manufacturing Standards Dedicated Elkem Silicones Quality Management System Bluestar clean operation standard following GMP principles and ISO guidelines Certified ISO 9001 Manufacturing Facility Certified ISO Class 8 Manufacturing Environment Certified ISO Class 7 Packaging Environment Responsible Care Management System Biocompatibility Tested according to ISO 10993/USP Class VI: 12-week implant Hemolysis USP Intracutaneous Reactivity USP Acute Systemic Toxicity Cytotoxicity Mutagenicity Pyrogenicity Skin Sensitization Tissue Irritation Drug Delivery Systems Silicone can function as a perfect matrix or membrane to control the release of specific drugs into the body. Localizing the delivery of the active ingredient and bypassing the blood flow can help to improve the bioavailability of the drug. The localized drug delivery may also allow for decreased active ingredient loading and can potentially reduce systemic side effects. This difficult task can be mastered by the tailor-made Bluestar series for drug delivery. The innovation potential is practically limitless because the silicone can be molded into virtually any shape. Specialty drug delivery silicones can be customized and adapted to various requirements to guarantee the most effective and targeted release right on the spot. Masterfile Support Device Master Access File (MAF) with FDA CDRH Drug Master File, Type IV (DMF) with FDA CDER Intra Uterine Devices Central Catheters Wound Drains Gastric Bands & Balloons Pacemakers Cochlear Implants Catheters Active Implantable Devices Vaginal rings 11

12 12 Silbione skin adhesives designed for durable yet gentle adhesion on skin

13 Elkem Silicones Soft Skin Adhesives Silbione Soft Skin Adhesives: your painless solution for wound care, scar care, and medical device attachment. Soft, Gentle Adhesion for an Easy, Painless and Non-Traumatic Removal The specific nature of silicone gels enables them to adhere softly to healthy skin. Silbione Soft Skin Adhesives are solvent free and biocompatible following the ISO standard, making them safe to use in sensitive applications like Advanced Wound Care. Silbione Soft Skin Adhesives controlled peel force ensures an easy and painless removal. Improved Wound Healing Silbione Soft Skin Adhesives are gas permeable, allowing the skin to breathe. Thanks to their hydrophobic nature, no adherence to moist wounds occurs, thereby enabling improved granulation and epithelialization. Silbione Soft Skin Adhesives work well in conjunction with complementary wound technologies such as nonwoven and polyurethane carriers to optimize the overall dressing performance. Silbione Soft Skin Adhesives: an ideal solution for a wide range of applications Cosmetic patches & masks Transdermal drug delivery systems Wearable devices Surgical drapes Medical tapes Medical device fixation Post-operative dressings Monitoring sensors First aid plasters Scar care sheets 13

14 Dental & Audiology Proven Tailor-made Silicone Dental Technology only for Private Label Elkem Silicones is exclusively a private label and B-to-B supplier. We develop and manufacture high-quality dental and audiology materials using our own technology, which ensures high fidelity, reliable impression and reproduction in a short period of time. By sourcing internally some key raw materials, we bring a high level of hydrophilicity, high thixotropy but high fluidity under shear, and friendly handling during use. We offer a wide range of Addition-silicone products: Vinyl Polymer Siloxanes for dental impression both 1:1 and 5:1, pastes and fluids for duplication and audiology. Over the course of 30 years, we have developed long-term partnerships with leading brands worldwide. We can supply bulk material, or be your packaging solution. Our products will then be marked or labeled with your brand and packaged according to your requirements. Just share with our team your layouts and we will manage the rest. You have something different in mind? Together we will find a solution to enable your differentiation. Our technical team is at your service for specific performance requirements, and we can leverage our supplier network for custom packaging. Our products are manufactured in controlled environment workshops, under the control of internal and external quality assurance, such as ISO 9001 & ISO Dental impression Packaging solutions for private labeling Dental duplication Audiology 14

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16 Silicones Delivering your potential Elkem Silicones Elkem Silicones 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 Elkem Silicones, 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, Elkem Silicones 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. Elkem Silicones 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 Elkem Silicones is at their disposal to supply any additional information. For detailed commercial contacts please visit our website: SIL Elkem Silicones 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.