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With support from industry and government leaders, ASTM International will host an organizational meeting to potentially create a new technical committee that develops voluntary consensus standards for commercial spaceflight. This meeting comes in part as a result of the updated U.S. Commercial Space Launch Competitiveness Act of 2015 (CSLCA). The U.S. Federal Aviation Administration’s…, ASTM Commercial Spaceflight Meeting:, Oct. 24, 2016, RTCA, Inc.; 1150 18th St. NW, 4th Floor, Washington, DC 20036, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #10170
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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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A series of proposed new ASTM International standards will help instrument manufacturers create modern and safe flight instruments designed for light sport aircraft and other similarly equipped and sized aircraft. The proposed standards are being developed by Subcommittee F39.03 on Design of Avionics Systems , part of ASTM International Committee F39 on Aircraft Systems . “The creation of…, Technical Contact:, Andrew Barker, TruTrak Flight Systems, Springdale, Ark., Phone: 479-751-0250; andrew@trutrakap.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 #9624
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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 new ASTM International standard will provide gasket manufacturers a test for measuring creep and compression that can be used for R&D and material comparisons, and as a quality assurance tool. ASTM F2837 , Test Method for Hot Compression Properties of Gasket Materials, was developed by Subcommittee F03.40 on Chemical Test Methods, under the jurisdiction of ASTM International Committee F03…, ASTM Committee F03 Next Meeting:, Oct 12-13, October Committee Week, San Antonio, Texas, Technical Contact:, James Lingenfelder, Gasket Resources Inc., Houston, Texas, Phone: 713-856-9445; jtling@durlon.com, ASTM Staff Contact:, Joseph Hugo, Phone: 610-832-9740; jhugo@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8695/Sept2010
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ASTM International Committee F03 on Gaskets has developed and approved a new standard that can be used to evaluate gasket materials covered by ASTM F104 , Classification System for Nonmetallic Gasket Materials. The new standard, F2716 , Practice for Comparison of Nonmetallic Flat Gaskets in High Pressure Saturated Steam, is under the jurisdiction of Subcommittee F03.10 on Composite Gaskets. ASTM…
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A new ASTM International standard responds to a recent emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments. The standard, ASTM E2614 , Guide for Evaluation of Cleanroom Disinfectants, was developed by Subcommittee E35.15 on Antimicrobial Agents, part of ASTM International Committee E35 on Pesticides and…
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As a means of ensuring the safety of electrical wiring systems in airplanes, ASTM International Committee F39 on Normal and Utility Category Airplane Electrical Wiring Systems has recently approved F2639 , Practice for Design, Alteration and Certification of Airplane Electrical Wiring Systems, a standard developed by Subcommittee F39.01 on Design, Alteration and Certification. According to…
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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…