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Irving S. Scher, Ph.D., P.E., a principal and biomechanical engineer at Guidance Engineering and Applied Research, will serve a three-year term on the ASTM International board of directors. Scher is based in Seattle, Washington. Guidance Engineering and Applied Research is an engineering and scientific consulting company that performs in-depth research and analysis for its clients. Scher holds…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10241
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Yesterday, Dr. Sudarsan Rachuri was given the 2016 ASTM International President’s Leadership Award. This recognizes individuals early in their ASTM International career who have significantly advanced the organization's mission through extraordinary accomplishment, example, and vision. Rachuri is serving as Editor-in-Chief of ASTM International’s new journal, Smart and Sustainable Manufacturing…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10176
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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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Snowboards that feature a single channel mounting system with removable inserts allow users to easily adjust the stance position of the bindings on their snowboards. A new ASTM International standard has now been developed that evaluates the insert retention strength of snowboards with channel-mounting systems. ASTM F3030 , Test Method for Snowboards with a Channel-Mounting System and Removable…, ASTM Committee F27 Next Meeting:, Jan. 24, 2014, Lakewood, Colo., Technical Contact:, Jeffrey Burga, Burton Snowboards, Burlington, Vt., Phone: 802-383-6993; jeffreyb@burton.com, ASTM Staff Contact:, Joe Koury, Phone: 610-832-9804; jkoury@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9558
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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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ASTM International is a recognized resource for snow skiing safety. From technical standard like test methods and specifications to state-of-the-art research, documents offered by ASTM International guide much of the safety measures available in skiing today. A fact sheet on ASTM International and Ski Safety can be found at www.astm.org/skiing . Snow Skiing Standards ASTM International Committee…, Skiing Trauma and Safety, , published in March 2009, features 21 papers written by individuals from many disciplines, all of who are interested in snow sports safety. Some of the papers included are: - Do Helmets Reduce Fatalities or Merely Alter the Patterns of Death?; - Head Kinematics During Experimental Snowboard Falls: Implications for Snow Helmet Standards; - Pediatric Head and Neck Injuries in Snow Sports:…
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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…
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The ASTM International committee formerly known as E55 on Pharmaceutical Application of Process Analytical Technology has undergone a change in title and scope that reflects the intent of the committee to be more inclusive of all the tools, instrumentation and sciences that might be used by the industry in the management of pharmaceutical manufacturing processes. The committee is now known as E55…