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The expected discontinuance in manufacturing a standard-reference test tire will lead to changes to an ASTM International standard ( E1136 , Specification for P195/75R14 Radial Standard Reference Test Tire). Users of this specification are invited to join an ASTM task group that is working to manage this transition. The tire has been used extensively since its introduction in the late 1980s.…, ASTM Committee F09 on Tires Next Meeting:, Oct. 13-14, 2015, MAPS Air Museum, North Canton, Ohio, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Angela Wolynski, Michelin North America, tel +1.864.422.4985; angela.wolynski@us.michelin.com, ASTM Staff Contact:, Julia Lively, tel +1.610.832.9681; jlively@astm.org Release #9880
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ASTM International and the Parenteral Drug Association recently signed a Memorandum of Understanding that launches a pilot to streamline efforts and conserve resources as both organizations develop technical guidance for the pharmaceutical industry. Katharine Morgan, executive vice president, ASTM, and Richard M. Johnson, president, PDA, signed the MOU. “The MOU between ASTM International and PDA…, ASTM Committee E55 on Manufacture of Pharmaceutical Products Next Meeting:, April 28-30, 2015, Lisbon, Portugal, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #9815 ###
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document a set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds. The proposed standard, ASTM WK39883 , Practice for Process of Inactivation of Enveloped…, ASTM Committee E55 Next Meeting:, April 9-11, 2013, Genzyme-A Sanofi Company, Haverhill, Suffolk, United Kingdom, Technical Contact:, John Schreffler, Ph.D., Morphotek Inc., Exton, Pa., Phone: 610-423-6557; jschreffler@morphotek.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9327
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A proposed new ASTM International standard will provide an important process step to be used in the manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactivate retroviruses. The proposed standard, ASTM WK36552 , Practice for Inactivation of Retrovirus by pH, is being developed by Subcommittee E55.04 on General Biopharmaceutical Standards , part of ASTM…
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A need for a scientifically based procedure to identify equivalent test severity conditions between a 1.707-m diameter laboratory roadwheel surface and a flat or highway surface for radial pneumatic light truck tires has led to the development and approval of a new ASTM International standard. The new standard, ASTM F2869 , Practice for Radial Light Truck Tires to Establish Equivalent Test…
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In the Transportation Recall Enhancement, Accountability and Documentation Act, the U.S. Congress indicated the need for an aging test on light vehicle tires. Since no industry or government standard addressed this subject, ASTM Committee F09 on Tires developed ASTM F2838 , Practice for Accelerated Laboratory Aging of Radial Passenger Car and Light Truck Tire Through Load Range E for the…
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The purpose of a laboratory roadwheel test is to realistically evaluate tires for specific road conditions. To facilitate such tests, ASTM International Committee F09 on Tires has developed a practice to provide an industry standard for commercial radial truck-bus tire laboratory temperature algorithms. The algorithms equilibrate with flat surface (highway) operating temperatures to determine…
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A rim slip performance test for tires that has been done at the Nevada Automotive Test Center for more than 20 years has now become an ASTM International standard. ASTM F2803 , Test Method for Evaluating Rim Slip Performance of Tires and Wheels, was developed by Subcommittee F09.20 on Vehicular Testing, part of ASTM International Committee F09 on Tires. Rim slip occurs when tire and wheel…, ASTM Committee F09 Next Meeting:, April 21-22, April committee week, St. Louis, Mo., Technical Contact:, Jason Whiteley, Nevada Automotive Test Center, Silver Springs, Nev., Phone: 775-629-2000, jwhiteley@natc-ht.com, ASTM Staff Contact:, Rick Lake, Phone: 610-832-9689; rlake@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8494/Feb2010
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While the continuous quality verification concept is still quite new, it has the potential to become an important approach to assuring product quality in the pharmaceutical industry. With this in mind, ASTM International Committee E55 on Manufacture of Pharmaceutical Products has approved a new standard, E2537 , Guide for Application of Continuous Quality Verification to Pharmaceutical and…
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products has developed a new standard that covers the life cycle of pharmaceutical and biopharmaceutical manufacturing systems. The new standard, E 2500 , Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, is under the jurisdiction of Subcommittee E55.03 on…