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News

Bayer Corporation Engineering Polymers For The Medical Industry

Bayer MaterialScience AG : 05 June, 2001  (Company News)
The Plastics and Polyurethanes Divisions of Bayer Corporation offer high-performance engineeringthermoplastics and polyurethane systems that are used in demanding applications in the medical industry.
Medical product manufacturers have come to rely on Bayer's Plastics and Polyurethanes Divisions toprovide technically advanced materials that can help meet the critical design, manufacturing and end-useperformance parameters of a variety of medical device and packaging applications.Locations

Bayer Corporation's Plastics Division is headquartered in Pittsburgh and has resin manufacturingfacilities in Addyston, Ohio; Baytown, Texas; and New Martinsville, W.Va.; a polycarbonate filmmanufacturing facility in Berlin, Conn.; a compounding facility in Newark, Ohio; and a styrenics researchfacility in Springfield, Mass. Other Plastics Division operations include Wolff Walsrode in Burr Ridge,Ill., Deerfield Urethanes Inc. in Whately, Mass., and Sheffield Plastics Inc. in Sheffield, Mass. Alsoheadquartered in Pittsburgh, Bayer Corporation's Polyurethanes Division has manufacturing facilities inBaytown, Texas, and New Martinsville, W.Va. Hennecke Machinery, which manufacturespolyurethane processing equipment, is a unit of the Polyurethanes Division located in the Pittsburghsuburb of Lawrence, Pa. Both Divisions are supported by the Polymers Research Centers, located inPittsburgh and New Martinsville, that develop new technologies and leverage Bayer AG internalresearch strength.

Major Applications

Among the many successful applications of Bayer's polymers are: X-ray development tanks; diagnosticdevices such as transducers; cardiovascular devices, including oxygenators, blood-heat exchangers andblood reservoirs; intravenous devices such as manifolds used in coronary arteriography, stopcocks,roller clamps, piercing pins, IV connection mechanisms, coronary control syringes and transfer devices;therapeutic and rehabilitative equipment, including housings for kidney dialyzers and humidifierchambers; and housings for a wide range of medical and laboratory equipment such as blood analyzers,desk-top centrifuges, diagnostic instrumentation and dental equipment, to name a few.

In addition, Bayer's polymers are used in a wide variety of other applications, including handles onsurgical equipment, contact- lens cases, diagnostic reaction cells and sterilizable laboratory animalbreeding cages. Only Bayer resins designated as 'medical-grade' may be considered as candidates forapplications requiring biocompatibility

Engineering Polymer Product Families

Makrolon® polycarbonate resins provide excellent impact strength, glass-like transparency,excellent temperature resistance, superior processability and dimensional stability. CertainMakrolon resins designated as 'medical-grade' meet FDA- modified ISO 10993-I requirements(see 'Biocompatibility'). Makrolon polycarbonate resins can be sterilized using a broadrange of sterilization techniques including EtO, steam and gamma or E- beam radiation (see'Sterilization').

Apec® high- heat polycarbonate resins extend the service range of Makrolon polycarbonate resinsto higher temperatures. These resins provide an excellent combination of high-heat resistance,clarity, toughness and processability. Certain Apec resins designated as 'medical-grade' meetFDA- modified ISO 10993-I requirements (see 'Biocompatibility'). Apec resins can beused in applications subjected to repeated autoclave (saturated steam) sterilization, especially athigher sterilization temperatures (see 'Sterilization').

Lustran® ABS (acrylonitrile-butadiene-styrene) and SAN (styrene acrylonitrile) resins provide anexcellent balance of properties for molded medical parts. Lustran ABS 348-1002 natural, 2002sno-white and other selected colors meet FDA- modified ISO 10993-I requirements (see'Biocompatibility'). SAN resins can exhibit 'water clear' optical clarity. SeveralLustran SAN resins for the medical market comply with USP 23 Class VI. Both Lustran ABS andSAN resins offer excellent chemical resistance and are sterilizable by EtO or gamma (see'Sterilization').

Bayblend® polycarbonate/ABS blends provide good toughness and impact resistance even at lowtemperatures, excellent color stability and consistency, easy processing, dimensional and thermalstability and excellent creep resistance. Flame- retardant (FR) grades are available which useadvanced FR technology that is antimony/bromine/chlorine-free. They also provide good thin-walldesign capability and are easily plateable or EMI-shielded. These resins have not been tested forbiocompatibility.

Makroblend® polycarbonate/polyester blends exhibit exceptional strength across a broadtemperature range and excellent chemical resistance. They are available in general purpose andflame- retardant grades and are easily EMI- or RFI-shielded using vacuum metalization, electronicplating or painting techniques. These resins have not been tested for biocompatibility.

Triax® ABS/polyamide blends offer ABS-like processing characteristics while a nylon-rich surfaceprovides superior chemical and abrasion resistance. Triax blends also exhibit higher heat resistancethan ABS resins. These resins have not been tested for biocompatibility according to FDA-modifiedISO 10993-I tests. However, Triax 1120-Q010 resin meets the USP 23 Class VIbiocompatibility requirements.

Makrofol® polycarbonate films and Bayfol® polycarbonate blend films are finding broad acceptancein a variety of medical equipment and medical packaging applications, including membrane switches,nameplates and sterilizable packaging. The films are easily embossed, debossed and readily acceptlaser and inkjet lot/code dating for critical part traceability. They also offer excellentthermoformability, high clarity and gloss, high-heat stability, superb impact resistance and excellentadhesion to medical lidding materials. Bayfol resins have not been tested for biocompatibility.Selected Makrofol polycarbonate films meet FDA-modified ISO 10993-I requirements (see'Biocompatibility').

Durethan® polyamide (nylon) resins provide an excellent balance of physical properties includinghigh dynamic fatigue resistance, outstanding chemical resistance, high strength and rigidity, attractivesurface appearance and high abrasion resistance. In addition to the standard polyamide 6 resins,Bayer offers high-performance reduced-moisture grades which offer improved dimensional stabilityand stiffness, higher flowability, reduced wall section capability and enhanced surface appearance.Durethan T40 resin is an amorphous polyamide designated as 'medical-grade' and meets FDA-modifiedISO 10993-I requirements ('Biocompatibility'). It offers transparency withexcellent chemical resistance, higher stiffness and sterilizability with ethylene oxide and gammaradiation (see 'Sterilization'). Film grades provide excellent crack resistance and barrierproperties.

Texin® thermoplastic polyurethanes combine the processing efficiencies of thermoplastics with thesuperior properties of high-grade polyurethane elastomers. Texin resins designated as 'medical-grade'meet FDA-modified ISO 10993-I requirements (see 'Biocompatibility' on page 5).Medical-grade Texin TPU resins not only feature biocompatibility and sterilizability, but they alsocontain no plasticizers, are latex-free and have low extractables. They provide excellent chemicalresistance, high tensile and tear strength, high elasticity and resilience, excellent abrasion resistance,excellent flexibility and good vibration dampening. They are available in a variety of hardness andstiffness ratings and are being used successfully for flexible tubing in a wide range of medicalapplications (see 'Sterilization').

Baydur® structural foam polyurethane RIM (reaction injection molding) systems provide large-partmoldability, design flexibility, chemical resistance, stiffness, impact resistance, in-mold coatingcapability and excellent surface finish for medical and dental equipment housings. These RIMsystems also offer excellent production economies. FR and non-FR grades are available. Theseresins have not been tested for biocompatibility.

PRISM® solid polyurethane RIM systems offer exceptional mechanical properties at thin wallthicknesses, attractive strength-to-weight ratios and good processability for medical equipmenthousings, along with those features described for Baydur systems.These resins have not been tested for biocompatibility.

Manufacturer's Responsibility

It is the responsibility of the medical device, biological product or pharmaceutical manufacturer ('Manufacturer') todetermine the suitability of all component parts and raw materials, including all Bayer resins used in its final productin order to ensure safety and compliance with FDA requirements. This determination must include, as applicable,testing for suitability as an implant device and suitability as to contact with and/or storage of human tissue andliquids including, without limitation, medication, blood or other bodily fluids. Under no circumstances, however, mayany Bayer resins be used in any cosmetic, reconstructive or reproductive implant applications. Nor may any Bayerresins be used in any other bodily implant applications, or any applications involving contact with or storage ofhuman tissue, blood or other bodily fluids, for greater than 30 days, based on FDA-modified ISO 10993-I 'BiologicalEvaluation of Medical Devices' tests. Furthermore, for aromatic grades of Texin resins, such longer term uses are notpermissible also because possible hydrolysis of solid polyurethane may produce aromatic amines, such as methylenedianiline (MDA).

The suitability of a Bayer product in a given end-use environment is dependent upon various conditions including,without limitation, chemical compatibility, temperature, part design, sterilization method, residual stresses or externalloads. It is the responsibility of the Manufacturer to evaluate its final product under actual end-use requirements andto adequately advise and warn purchasers and users thereof.Single-use medical devices made from a Bayer product are not suitable for multiple uses. If the medical device isdesigned formultiple uses, it is the responsibility of the Manufacturer to determine the appropriate number ofpermissible uses by evaluating the device under actual sterilization and end-use conditions and to adequately adviseand warn purchasers and users thereof.

Sterilization

The sterilization method and the number of sterilization cycles a medical device made from Bayer resins can withstandwill vary depending upon type/grade of product, part design, processing parameters, sterilization temperature andchemical environment. Therefore, the Manufacturer must evaluate each device to determine the sterilization methodand the number of permissible sterilization cycles appropriate for actual end- use requirements and must adequatelyadvise and warn purchasers and users thereof.

Parts molded or extruded from Texin resins are sterilizable using ethylene oxide, radiation, or dry heat. Parts made ofTexin resins must not be sterilized using steam autoclaving or boiling water techniques. Furthermore, thesesterilization methods must not be used with aromatic grades of Texin resins because possible hydrolysis of solidpolyurethane may produce aromatic amines, such as methylene dianiline (MDA).

Biocompatibility

All Bayer resins designated as 'medical-grade' have met the requirements of the FDA-modified ISO 10993- I'Biological Evaluation of Medical Devices' tests with human tissue contact time of 30 days or less. ONLY THESEPRODUCTS MAY BE CONSIDERED CANDIDATES FOR APPLICATIONS REQUIRING BIOCOMPATIBILITY. No'medical-grade' products will be available for sale until successful completion of testing.REGRIND RESINS MUST NOT BE USED IN MEDICAL APPLICATIONS REQUIRING BIOCOMPATIBILITY.

Regulatory Compliance

Some of the end-uses of Bayer's products described in this overview must comply with applicable regulations fromagencies such as the FDA, NSF, USDA and CPSC. If you have any questions on the regulatory status of theseproducts, consult your Bayer representative or contact the Bayer Regulatory Affairs Manager in Pittsburgh, Pa.

Lustran, PRISM, Texin and Triax are registered trademarks of Bayer Corporation.
Apec, Bayblend, Baydur, Bayfol, Desmopan, Durethan, Makroblend, Makrofol and Makrolon are registeredtrademarks of Bayer AG.
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