| Corrected February 6, 2009. |
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If you have difficulty reading this e-mail, you can view it on our Bayer MaterialScience NAFTA Web Site.
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This e-mail provides a preview of the articles in the current issue of our newsletter. To read the full issue, select the PDF file link under the "PDF VERSION" heading in the right margin of this e-mail. You must have Adobe Acrobat® Reader software to open the file. If you don't have this software, you can download it at no cost from the www.adobe.com Web site.
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We hope you enjoy this informative and easy-to-read resource. If you have any questions or content ideas of your own, please e-mail us at medicalinfo@bayer.com. And please share this with your co-workers.
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The Skin-ny on a New Grade of Bayblend®
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Continuing its role as a leader in materials for the healthcare market, Bayer MaterialScience (BMS) introduces Bayblend® M301 FR polycarbonate/ABS blend – an innovative material developed specifically for use with surface device applications contacting intact skin.
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Bayblend M301 FR meets Food and Drug Administration (FDA) ISO 10993-5 for cytotoxicity and ISO 10993-10 for irritation and sensitization testing requirements. Potential applications include insulin pumps and respiratory devices, among others.
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“The material’s combination of physical properties, flame retardance and compliance with these three ISO biocompatibility standards provides medical device and equipment manufacturers with an added safety factor and increased confidence. This, in turn, may potentially streamline the approval process so they are able to bring life-saving products to market more quickly,” said Kevin Dunay, market segment leader, Medical Polycarbonates NAFTA, BMS.
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The resin is supplied in pellet form for injection molding applications and is available in opaque gray. Other opaque colors that utilize biocompatibility tested colorants can also be formulated. The flame retardant additive to this grade is antimony-, bromine-, and chlorine-free.
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Bayblend M301 FR polycarbonate/ABS blend is the latest in a long line of material innovations from BMS. For almost 50 years, medical device OEMs and the healthcare market have relied on BMS’ proven materials and technical expertise. It’s a track record that includes Makrolon polycarbonate utilized for the first blood oxygenators and renal dialyzers in the 1960s.
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Click hereto find product information on Bayblend M301 FR polycarbonate/ABS blend.
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For more information contact Bayer MaterialScience's Medical Market Manager Kevin Dunay at 412-777-2316 or kevin.dunay@bayerbms.com.
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Look No Further: Innovative Ophthalmic Instruments Made Possible with Makrolon® Polycarbonate
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The Grieshaber Revolution™ DSP micro forceps and scissors from Alcon Greishaber AG are a new generation of instruments to help combat vision-impairing retinal disease. And you don't have to look very hard to see why these instruments are revolutionary: The forceps and scissors can be freely rotated while being used, unlike similar commercial surgical instruments.
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This extremely beneficial function is made possible in part by a plastic basket of thin-walled ribs that forms part of the instrument body - thin-walled ribs that required a material with strength, stiffness and toughness. Of course, Alcon Greishaber, a leading medical technology manufacturer based in Switzerland, called upon Bayer MaterialScience (BMS) for such a material, and Makrolon® 2458 polycarbonate resin was a perfect fit.
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"Our Makrolon 2458 polycarbonate, which is approved for medical applications, fulfilled all these requirements. Its excellent dimensional stability also makes it possible for this delicate injection-molded component to be easily demolded and for the forceps or scissors to work reliably," explains Markus Krieter, Medical Market Manager in the Polycarbonates Business Unit of BMS AG.
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Of the single-use operating instrument's individual components, eight are made of Makrolon polycarbonate. The manufacturer of these polycarbonate parts is Gebr. Renggli AG in Schaffhausen, an internationally renowned expert in precision injection molding and mold construction. The parts are manufactured using a laminar flow process, then cleaned and finished in a cleanroom. The actual instruments themselves are assembled in a cleanroom at Alcon Grieshaber.
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This application reinforces how versatile Makrolon polycarbonate resin can bring even the most revolutionary health care products - like the Grieshaber Revolution DSP micro forceps and scissors - to life.
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The Colorful Cure for ISO-Compliance
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Healthcare applications and medical devices have traditionally been stuck behind beige and white barriers, but Bayer MaterialScience (BMS) and its "Rx Medical" line of LEDA® compounded color technology have broken that barrier. The new line of colors can brighten up medical devices while still remaining compliant with the industry standard for biocompatibility, FDA-modified ISO 10993-1. The Rx Medical line of LEDA colors and special effects are for use with BMS' medical-grade Makrolon® polycarbonate resin and Bayblend® polycarbonate/ABS blend resin. The four new Rx Medical colors are ISO 10993-1 compliant, making them an innovative new option for the design of medical applications, such as drug delivery devices and components of surgical instruments, among others. |
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The new colors that join the existing Rx Medical colors of Gamma, Scope and Twilight allow more versatility in bringing the beige and white healthcare market to life:
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- Electro - Electro, a modern-looking medium blue tempered with gray, adds a little zing to confidence and practicality.
- First Aid - A whimsical take on beige, First Aid is a light brown dabbling in gray. It's soothing for a natural, understated look.
- Stat - An attention grabbing red/purple/gray hybrid with a muted personality, Stat also manages to be professional and secure
- X-Ray - Tinged with a hint of gray, X-Ray is modern take on the "standard" bleach-white color traditionally used in the medical industry and a radical departure from boring beige.
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"The medical industry is heavily regulated for safety, but this has also made it a challenge for our customers to find ISO-compliant colors for medical applications," said Kevin Dunay, BMS Market Segment Leader for Consumer and Healthcare Markets. "Bayer is a leader for polycarbonates used in medical applications. We are expanding on this leadership and increasing the versatility of our materials by offering our customers a wide range of innovative color choices for medical applications.
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| To learn more about the Rx Medical family of polycarbonate colors as well as the comprehensive line of color technologies available from BMS, visit http://www.bayerfantasia.com/, or e-mail us at pcinfo@bayer.com. |
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Click here to view the full press release.
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For more information contact Bayer MaterialScience's Medical Market Manager Kevin Dunay at 412-777-2316 or kevin.dunay@bayerbms.com.
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Paging A New Family of Coatings to Surgery
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Building on its experience in polyurethane coatings chemistry, Bayer MaterialScience recently developed a new family of hydrophilic coatings intended to increase the lubricity of medical devices. Relevant applications include catheters, guidewires, leads, and endoscopes, where reduced friction with tissue during surgical procedures is desired. They are also ideal in applications where resistance to mechanical stress is a concern.
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The hydrophilic coatings, with a tensile strength of about 25 MPa (3600 psi), are particularly strong compared with competing products. Also, the volumetric swelling in water is small (10-35 percent), whereas most lubricious materials swell greatly into a hydrogel.
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| Two distinct types of formulations are available: aqueous polyurethane dispersions and solvent borne polyurethane solutions. Certain applications can take advantage of the solvent-free nature and low viscosity of aqueous dispersions. In other cases, solvent-borne coatings, which are characterized by their exceptional stability and wet strength, are preferred. Solvent-borne coatings are supplied in a mixture of toluene and isopropanol, two comparatively mild and low-boiling solvents. |
Both the aqueous dispersions and the solution formulations are one-component products, where the physical entanglement of polymer chains during evaporative curing yields a durable and insoluble film. The aqueous dispersions are supplied as 40 percent solids, while the solutions are 30 percent solids. Each can be applied by conventional methods: dip coating, spraying, spin coating or by blade. |
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The hydrophilicity is achieved by means of a unique polymer architecture. As a coating is formed from the solution or dispersion upon drying, the hydrophilic end groups on the polymer molecule partition preferentially to the external surface. The enrichment of hydrophilic groups on the film surface results in water contact angles as low as 10°.
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| Films of these products showed no in vitro cytotoxicity (ISO 10993-5). Furthermore, preliminary experiments showed low activation of the coagulation cascade and low thrombocyte activation, suggesting good hemocompatibility. |
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Several developmental formulations are available to meet specific requirements for flexibility, strength and degree of hydrophilicity. These products are experimental, and limited quantities are being sampled to qualified parties for evaluation.
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For more information on Bayer MaterialScience's hydrophilic coatings, contact Paul Nowatzki at 412-777-3074 or paul.nowatzki@bayerbms.com.
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Tough Stuff: Maximizing Impact Resistance of Molded Medical Components
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Medical devices are one of the most critical instruments in the world - and Bayer MaterialScience materials play a huge role in the design of those life-saving applications. Factors such as miniaturization, portability, and the high risks associated with part failure compel medical device manufacturers to optimize part toughness.
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In an article titled Enhancing Impact Resistance and Toughness in Molded Medical Parts, author Mark Yeager, Principal Engineer, Bayer MaterialScience, examines the necessary attributes that should be taken into consideration when a medical device is designed and produced. The paper examines material selection, stress concentrators, molding and finishing, and part geometry in order to achieve maximum toughness in an injection molded component for a medical device.
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To view the entire article, please click here.
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Sustainability Means Business
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| Bayer is dedicated to sustainable development, with economy, ecology and social consciousness given equal importance in all company activities. This commitment has a constant impact on the products Bayer produces, the markets it serves and the company's day-to-day business operations. |
Bayer actively communicates about its sustainable efforts. Bayer's Sustainable Development Report describes Bayer's global sustainability activities, results and objectives. Highlights of the 100-page report include details about Bayer's Climate Program, which focuses on climate-friendlier production, zero-emission buildings and plant-based energy resources; as well as Bayer's commitment to social projects, particularly in the areas of education, health promotion and environmental protection. |
| With the understanding that customers are also looking for greener alternatives, Bayer MaterialScience's polycarbonates business unit has developed a new brochure focused specifically on the eco-friendly aspects of its polycarbonate resins, blends and films. LEDs, sustainable construction and automotive applications are just a few of the areas highlighted in this 12-page brochure, available in the first quarter of this year. The brochure will be available on the Polycarbonates Web site. |
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More information about Bayer's Sustainable Development Report 2007 click here.
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