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Tekni-Plex expands medical portfolio with Dunn Industries acquisition
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WAYNE, Pa.—Tekni-Plex Inc. is expanding its capabilities in specialty extruded medical tubing by acquiring Dunn Industries Inc. Financial details were not disclosed, but Tekni-Plex said the ...
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WAYNE, Pa.—Tekni-Plex is expanding its capabilities in specialty extruded medical tubing by acquiring Dunn Industries. WAYNE, Pa.—Tekni-Plex is expanding its capabilities in specialty extruded medical tubing by acquiring Dunn Industries. $WAYNE, Pa.—Tekni-Plex is expanding its capabilities in specialty extruded medical tubing by acquiring Dunn Industries.
Raw material prices still volatile
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WASHINGTON—Volatility in raw materials prices for tires and rubber goods has moderated since last year, but is far from gone, according to manufacturers and industry analysts. Tire...
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WASHINGTON—Volatility in raw materials prices for tires and rubber goods has moderated since last year, but is far from gone, according to manufacturers and industry analysts. WASHINGTON—Volatility in raw materials prices for tires and rubber goods has moderated since last year, but is far from gone, according to manufacturers and industry analysts. $WASHINGTON—Volatility in raw materials prices for tires and rubber goods has moderated since last year, but is far from gone, according to manufacturers and industry analysts.
Bridgestone, Goodyear to create 50/50 wholesale venture
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AKRON—Bridgestone Americas and Goodyear are combining their respective wholesale tire distribution assets into a 50/50 joint venture, called TireHub L.L.C., that will operate through 80-...
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AKRON—Bridgestone Americas and Goodyear are combining their respective wholesale tire distribution assets into a 50/50 joint venture, called TireHub, that will operate through 80-plus distribution centers nationwide. AKRON—Bridgestone Americas and Goodyear are combining their respective wholesale tire distribution assets into a 50/50 joint venture, called TireHub, that will operate through 80-plus distribution centers nationwide. $AKRON—Bridgestone Americas and Goodyear are combining their respective wholesale tire distribution assets into a 50/50 joint venture, called TireHub, that will operate through 80-plus distribution centers nationwide.
Impact of steel tariffs looms over industry
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WASHINGTON—Tire manufacturers still are assessing the possible effects of 25 percent tariffs on tire-quality steel wire rod imports to the U.S., but all indications are that the impact...
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WASHINGTON—Tire manufacturers still are assessing the possible effects of 25 percent tariffs on tire-quality steel wire rod imports to the U.S., but all indications are that the impact could be sweeping. WASHINGTON—Tire manufacturers still are assessing the possible effects of 25 percent tariffs on tire-quality steel wire rod imports to the U.S., but all indications are that the impact could be sweeping. $WASHINGTON—Tire manufacturers still are assessing the possible effects of 25 percent tariffs on tire-quality steel wire rod imports to the U.S., but all indications are that the impact could be sweeping.
Photo gallery: Ace shows off expansion
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RAVENNA, Ohio—At Ace Products and Consulting's open house on April 12, visitors showed up to see the facility after the company finished its most recent expansion. Ace added 3,500 square...
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RAVENNA, Ohio—At Ace Products and Consulting's open house on April 12, visitors showed up to see the facility after the company finished its most recent expansion. RAVENNA, Ohio—At Ace Products and Consulting's open house on April 12, visitors showed up to see the facility after the company finished its most recent expansion. $RAVENNA, Ohio—At Ace Products and Consulting's open house on April 12, visitors showed up to see the facility after the company finished its most recent expansion.
Continental developing aquaplaning warning system
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FRANKFURT, Germany—Continental A.G. engineers are developing an aquaplaning alert system that uses signals from surround-view cameras and tire-mounted electronic sensors to warn the...
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FRANKFURT, Germany—Continental engineers are developing an aquaplaning alert system that uses signals from surround-view cameras and tire-mounted electronic sensors to warn the vehicle's driver and engage active stabilization measures. FRANKFURT, Germany—Continental engineers are developing an aquaplaning alert system that uses signals from surround-view cameras and tire-mounted electronic sensors to warn the vehicle's driver and engage active stabilization measures. $FRANKFURT, Germany—Continental engineers are developing an aquaplaning alert system that uses signals from surround-view cameras and tire-mounted electronic sensors to warn the vehicle's driver and engage active stabilization measures.
Doublestar set to take control of Kumho
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SEOUL, South Korea—Qingdao Doublestar Group may finally be gaining control of Kumho Tire Co. Ltd.After nearly a year of offers, Kumho said in an April 1 statement that its management and...
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SEOUL, South Korea—Qingdao Doublestar Group may finally be gaining control of Kumho Tire. SEOUL, South Korea—Qingdao Doublestar Group may finally be gaining control of Kumho Tire. $SEOUL, South Korea—Qingdao Doublestar Group may finally be gaining control of Kumho Tire.
Commerce postpones countervailing duty determination on rubber bands
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WASHINGTON—At the request of Alliance Rubber Co., the U.S. Department of Commerce is postponing its countervailing duty determinations on rubber bands imported from China and Thailand until...
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WASHINGTON—At the request of Alliance Rubber, the U.S. Department of Commerce is postponing its countervailing duty determinations on rubber bands imported from China and Thailand until July 2. WASHINGTON—At the request of Alliance Rubber, the U.S. Department of Commerce is postponing its countervailing duty determinations on rubber bands imported from China and Thailand until July 2. $WASHINGTON—At the request of Alliance Rubber, the U.S. Department of Commerce is postponing its countervailing duty determinations on rubber bands imported from China and Thailand until July 2.
Editorial: Time to downshift self-driving to a slightly lower gear
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Momentum can be a phenomenon that cuts both ways. On the good side, it can carry a promising technology over the finish line if the right parties put the proper support behind it. On the flip...
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When it comes to transportation, safety must always be the top priority. While many predict that self-driving vehicles will cut accidents drastically, more advancements are needed to make this a reality. When it comes to transportation, safety must always be the top priority. While many predict that self-driving vehicles will cut accidents drastically, more advancements are needed to make this a reality. $When it comes to transportation, safety must always be the top priority. While many predict that self-driving vehicles will cut accidents drastically, more advancements are needed to make this a reality.
Auto suppliers splitting in two to deliver next-generation technologies
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Auto component suppliers around the world are tearing themselves apart. On purpose. They are convinced that by no longer being conglomerates, they will gain favor from investors and industry...
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Auto component suppliers are convinced that by no longer being conglomerates, they will gain favor from investors and industry customers. And so, like amoebas under a microscope, parts makers are splitting in two. Auto component suppliers are convinced that by no longer being conglomerates, they will gain favor from investors and industry customers. And so, like amoebas under a microscope, parts makers are splitting in two. $Auto component suppliers are convinced that by no longer being conglomerates, they will gain favor from investors and industry customers. And so, like amoebas under a microscope, parts makers are splitting in two.
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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