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Jobs, supply chain, growth: Why auto is an important part of NAFTA
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TORONTO—The future of Canada's more than one million automotive jobs has emerged as a critical part of what's at stake at the NAFTA renegotiation table in Washington after the U.S. chief...
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TORONTO—The future of Canada's more than one million automotive jobs has emerged as a critical part of what's at stake at the NAFTA renegotiation table in Washington. TORONTO—The future of Canada's more than one million automotive jobs has emerged as a critical part of what's at stake at the NAFTA renegotiation table in Washington. $TORONTO—The future of Canada's more than one million automotive jobs has emerged as a critical part of what's at stake at the NAFTA renegotiation table in Washington.
Continental, Kordsa partner on adhesion system development
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HANOVER, Germany—Continental A.G.'s tire division is partnering with Kordsa Inc., an international supplier of textile reinforcing materials for the tire industry, to develop a sustainable...
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HANOVER, Germany—Continental's tire division is partnering with Kordsa to develop a sustainable adhesion system standard for bonding textile reinforcing materials to rubber-based compounds. HANOVER, Germany—Continental's tire division is partnering with Kordsa to develop a sustainable adhesion system standard for bonding textile reinforcing materials to rubber-based compounds. $HANOVER, Germany—Continental's tire division is partnering with Kordsa to develop a sustainable adhesion system standard for bonding textile reinforcing materials to rubber-based compounds.
Barco opens new Georgia plant
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TALLAPOOSA, Ga.—British American Rubber Co., a subsidiary of Montague Investments L.L.C., invested about $10 million to build a specialty rubber compounding facility in Tallapoosa, according ...
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TALLAPOOSA, Ga.—British American Rubber, a subsidiary of Montague Investments, invested about $10 million to build a specialty rubber compounding facility in Tallapoosa, according to President Mike Cash. TALLAPOOSA, Ga.—British American Rubber, a subsidiary of Montague Investments, invested about $10 million to build a specialty rubber compounding facility in Tallapoosa, according to President Mike Cash. $TALLAPOOSA, Ga.—British American Rubber, a subsidiary of Montague Investments, invested about $10 million to build a specialty rubber compounding facility in Tallapoosa, according to President Mike Cash.
Funding leads Fluence Analytics to new phase
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NEW ORLEANS—Back in May, Fluence Analytics said it had raised a Series A round of funding led by Energy Innovation Capital, a venture capital firm that invests in growing companies in energy ...
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NEW ORLEANS—With a Series A round of funding led by Energy Innovation Capital, Fluence Analytics has set a course for growth. NEW ORLEANS—With a Series A round of funding led by Energy Innovation Capital, Fluence Analytics has set a course for growth. $NEW ORLEANS—With a Series A round of funding led by Energy Innovation Capital, Fluence Analytics has set a course for growth.
Decentralized approach works for Singer
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SAN ANTONIO—For SBP Holdings, parent of rubber goods distributor Singer Equities Inc., it was a big deal when it boosted the size of its corporate staff by 33 percent. That's right, it went ...
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SAN ANTONIO—SBP, parent of rubber goods distributor Singer Equities, has stuck to a decentralized business approach as it has grown significantly, aided by 19 acquisitions made since 1999. SAN ANTONIO—SBP, parent of rubber goods distributor Singer Equities, has stuck to a decentralized business approach as it has grown significantly, aided by 19 acquisitions made since 1999. $SAN ANTONIO—SBP, parent of rubber goods distributor Singer Equities, has stuck to a decentralized business approach as it has grown significantly, aided by 19 acquisitions made since 1999.
Katz sees growth opportunities for polyurethanes
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Linda Katz, the Polyurethanes Manufacturers Association's new president, is very familiar with the plastics world. Her father ran an injection molding company in Wisconsin and she worked there as ...
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Linda Katz discusses the potential of polyurethanes in a variety of industries. Linda Katz discusses the potential of polyurethanes in a variety of industries. $Linda Katz discusses the potential of polyurethanes in a variety of industries.
Cooper Tire completes guayule grant
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FINDLAY, Ohio—Cooper Tire & Rubber Co. and its consortium partners have completed their five-year, $6.9 million Biomass Research and Development Initiative grant on guayule rubber....
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FINDLAY, Ohio—Cooper Tire and its consortium partners have completed their five-year, $6.9 million Biomass Research and Development Initiative grant on guayule rubber. FINDLAY, Ohio—Cooper Tire and its consortium partners have completed their five-year, $6.9 million Biomass Research and Development Initiative grant on guayule rubber. $FINDLAY, Ohio—Cooper Tire and its consortium partners have completed their five-year, $6.9 million Biomass Research and Development Initiative grant on guayule rubber.
Texarkana backing potential Cooper Tire project
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TEXARKANA, Ark.—The city of Texarkana authorized the issuance of industrial development bonds valued at up to $250 million to be used to support investment by Cooper Tire & Rubber Co....
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TEXARKANA, Ark.—The city of Texarkana authorized the issuance of industrial development bonds valued at up to $250 million to be used to support investment by Cooper Tire in its car and light truck tire plant in the Arkansas city. TEXARKANA, Ark.—The city of Texarkana authorized the issuance of industrial development bonds valued at up to $250 million to be used to support investment by Cooper Tire in its car and light truck tire plant in the Arkansas city. $TEXARKANA, Ark.—The city of Texarkana authorized the issuance of industrial development bonds valued at up to $250 million to be used to support investment by Cooper Tire in its car and light truck tire plant in the Arkansas city.
Hyde: Feedstock volatility to continue
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FAIRLAWN, Ohio—Change will continue to be prevalent among synthetic latex feedstocks, but that doesn’t necessarily mean good news for the industry. That was the message from Bill Hyde,...
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FAIRLAWN, Ohio—Change will continue to be prevalent among synthetic latex feedstocks, but that doesn't necessarily mean good news for the industry. FAIRLAWN, Ohio—Change will continue to be prevalent among synthetic latex feedstocks, but that doesn't necessarily mean good news for the industry. $FAIRLAWN, Ohio—Change will continue to be prevalent among synthetic latex feedstocks, but that doesn't necessarily mean good news for the industry.
Dow, DuPont set closing date for merger
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MIDLAND, Mich.—Dow Chemical Co. and DuPont Co. have set a closing date for their merger of equals. The firms disclosed in a news release that all required regulatory approvals and...
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MIDLAND, Mich.—Dow and DuPont have set a closing date for their merger of equals. MIDLAND, Mich.—Dow and DuPont have set a closing date for their merger of equals. $MIDLAND, Mich.—Dow and DuPont have set a closing date for their merger of equals.
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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