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Researchers bring 'Thubber' to life
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PITTSBURGH—"Flubber" was just a joke from the Walt Disney Studios. But "thubber," a thermally conductive rubber material for making soft, stretchable machines and electronics, is now a...
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PITTSBURGH—Researchers at Carnegie Mellon University have developed an electrically insulating composite that offers a combination of metal-like thermal conductivity and elasticity capable of stretching more than six times its initial length. PITTSBURGH—Researchers at Carnegie Mellon University have developed an electrically insulating composite that offers a combination of metal-like thermal conductivity and elasticity capable of stretching more than six times its initial length. $PITTSBURGH—Researchers at Carnegie Mellon University have developed an electrically insulating composite that offers a combination of metal-like thermal conductivity and elasticity capable of stretching more than six times its initial length.
Changed vote makes difference in ITC decision
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WASHINGTON—The shift of one vote caused the International Trade Commission to make a final determination that the U.S. truck and bus tire manufacturing industry is not being materially...
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WASHINGTON—The shift of one vote caused the International Trade Commission to make a final determination that the U.S. truck and bus tire manufacturing industry is not being materially injured because of imports from China. WASHINGTON—The shift of one vote caused the International Trade Commission to make a final determination that the U.S. truck and bus tire manufacturing industry is not being materially injured because of imports from China. $WASHINGTON—The shift of one vote caused the International Trade Commission to make a final determination that the U.S. truck and bus tire manufacturing industry is not being materially injured because of imports from China.
Goodyear, Cooper Tire employees honored with STEP Ahead awards
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AKRON—The Manufacturing Institute will honor five women who work for Goodyear and Cooper Tire & Rubber Co. at its upcoming Women in Manufacturing STEP (Science, Technology, Engineering...
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AKRON—The Manufacturing Institute will honor five women who work for Goodyear and Cooper at its upcoming Women in Manufacturing STEP (Science, Technology, Engineering and Production) Ahead Awards. AKRON—The Manufacturing Institute will honor five women who work for Goodyear and Cooper at its upcoming Women in Manufacturing STEP (Science, Technology, Engineering and Production) Ahead Awards. $AKRON—The Manufacturing Institute will honor five women who work for Goodyear and Cooper at its upcoming Women in Manufacturing STEP (Science, Technology, Engineering and Production) Ahead Awards.
James Walker to unveil new elastomer family
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CHESHIRE, England—A sealing products manufacturer from the United Kingdom is ready to release a new family of elastomers it will use in its goods to meet the ever-increasing demands of the...
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CHESHIRE, England—A sealing products manufacturer from the United Kingdom is ready to release a new family of elastomers it will use in its goods to meet the ever-increasing demands of the oil and gas industry. CHESHIRE, England—A sealing products manufacturer from the United Kingdom is ready to release a new family of elastomers it will use in its goods to meet the ever-increasing demands of the oil and gas industry. $CHESHIRE, England—A sealing products manufacturer from the United Kingdom is ready to release a new family of elastomers it will use in its goods to meet the ever-increasing demands of the oil and gas industry.
Oil and gas market looking up, but profits hard to come by
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WASHINGTON—This year will be better than 2016 for the oil and gas industry and the rubber and polymer product manufacturers that supply them, according to industry officials and experts....
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WASHINGTON—This year will be better than 2016 for the oil and gas industry and the rubber and polymer product manufacturers that supply them, according to industry officials and experts. WASHINGTON—This year will be better than 2016 for the oil and gas industry and the rubber and polymer product manufacturers that supply them, according to industry officials and experts. $WASHINGTON—This year will be better than 2016 for the oil and gas industry and the rubber and polymer product manufacturers that supply them, according to industry officials and experts.
China slides to No. 2 tire trading partner
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AKRON—Canada replaced China last year as the No. 1 trading partner of the U.S. in tires. The value of China's imports to the U.S.—impacted primarily by the cut in consumer tire...
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AKRON—Canada replaced China last year as the No. 1 trading partner of the U.S. in tires. AKRON—Canada replaced China last year as the No. 1 trading partner of the U.S. in tires. $AKRON—Canada replaced China last year as the No. 1 trading partner of the U.S. in tires.
ITC antidumping decision brings mixed reactions
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As with any decision regarding imported tires and tariffs and duties, there are winners and losers.That certainly is the case following the surprising Feb. 22 decision by the U.S. International...
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As with any decision regarding imported tires and tariffs and duties, there are winners and losers. As with any decision regarding imported tires and tariffs and duties, there are winners and losers. $As with any decision regarding imported tires and tariffs and duties, there are winners and losers.
Henkel, Benteler making composite leaf springs for Volvo
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DUESSELDORF, Germany—Laundry and personal care products-to-reactive polyurethane systems company, Henkel A.G. and automotive composites firm Benteler S.G.L. are supplying polyurethane...
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DUESSELDORF, Germany—Henkel and Benteler are supplying polyurethane composite leaf springs to the Volvo S90 and V90 following their introduction on the XC90 crossover SUV. DUESSELDORF, Germany—Henkel and Benteler are supplying polyurethane composite leaf springs to the Volvo S90 and V90 following their introduction on the XC90 crossover SUV. $DUESSELDORF, Germany—Henkel and Benteler are supplying polyurethane composite leaf springs to the Volvo S90 and V90 following their introduction on the XC90 crossover SUV.
Lubrizol invests to grow medical unit
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ANAHEIM, Calif.—Lubrizol Corp.'s LifeSciences unit has added thermoplastic polyurethane compounding abilities through a partnership with a medical compounder. Compounding Solutions, which...
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ANAHEIM, Calif.—Lubrizol's LifeSciences unit has added thermoplastic polyurethane compounding abilities through a partnership with a medical compounder. ANAHEIM, Calif.—Lubrizol's LifeSciences unit has added thermoplastic polyurethane compounding abilities through a partnership with a medical compounder. $ANAHEIM, Calif.—Lubrizol's LifeSciences unit has added thermoplastic polyurethane compounding abilities through a partnership with a medical compounder.
Doublestar inks Kumho deal, but Park counter-offer looms
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SEOUL, South Korea—China's Qingdao Doublestar Co. said it has signed an agreement with Kumho Tire creditors to buy a 42 percent stake in the South Korean tire maker in a deal that could...
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SEOUL, South Korea—Doublestar said it has signed an agreement with Kumho Tire creditors to buy a 42 percent stake in the South Korean tire maker in a deal that could enable Doublestar to further expand in China. SEOUL, South Korea—Doublestar said it has signed an agreement with Kumho Tire creditors to buy a 42 percent stake in the South Korean tire maker in a deal that could enable Doublestar to further expand in China. $SEOUL, South Korea—Doublestar said it has signed an agreement with Kumho Tire creditors to buy a 42 percent stake in the South Korean tire maker in a deal that could enable Doublestar to further expand in China.
Digital Edition
Digital Edition
Published on January 1, 2009

Characteristics of Rubber Used in Pharmaceuticals

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Date Published January 1, 2009
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This Report has been authored by:Fran L. DeGrazio at West PharmaceuticalServices Inc. #with# Jim Castner at Lantheus Medical Imaging #with# Wai Keung Wong at ExxonMobil Chemical Europe #with# Dennis Jenke at Baxter Healthcare Corp. #with# Daniel L. Norwood at Boehringer Ingelheim Pharmaceutics,” says Scheumann. Jason fpICC

Rubber materials are widely used in systems used to manufacture, package and deliver pharmaceutical products. While the rubber material’s nature and composition gives it its necessary and desirable performance characteristics, these material properties can have important and potentially detrimental consequences for the pharmaceutical products. Interactions between these materials and the pharmaceutical products they contact are well known and documented and can result in a change in the product’s composition, which may adversely affect product safety (e.g., the product produces an unanticipated and adverse user response) and/or efficacy (e.g., the product performs in a manner inconsistent with its labeling and indication). Therefore, rubber materials used in pharmaceutical products must be evaluated to determine what material components can, and do, migrate from the materials and accumulate in the pharmaceutical product, as it is through the presence and actions of such substances that product safety and/or efficacy may be compromised.

The characterization of materials for their extractables (substances that can migrate) and of products for their leachables (substances that do accumulate) is a necessary and complex part of the development, registration and manufacturing and distribution and therapeutic products.

This manuscript provides a general overview of the extractables and leachables issues associated with materials used with/in therapeutic products. 

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