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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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New ASTM Committee F44 to Develop Standards That Will Streamline Certification Process, Empower Innovation, ASTM International announces the formation of Committee F44 on General Aviation Aircraft , bringing together global stakeholders to work on a standards roadmap that will help transform the way smaller aircraft are manufactured and certified around the world. The new ASTM Committee F44 was formed at the request of aviation industry organizations in support of the efforts of the Federal Aviation…, Driving Change through ASTM Consensus Standards, The efforts of Committee F44 will play a critical role in supporting the overhaul of Part 23 regulations into what the FAA envisions as more of a performance-based document. Industry-driven F44 standards for the design and airworthiness of general aviation aircraft will serve to better align aircraft certification requirements with the type of operation the aircraft will experience. “Simplified,…, ASTM International: Global Heritage in Aviation Standards Development, ASTM’s broad portfolio of aviation-related standards has been created through the work of its existing technical committees dedicated to the field, including F07 on Aerospace and Aircraft , F37 on Light Sport Aircraft and F39 on Aircraft Systems . More than 20 Committee F37 standards have been cited by the FAA in regulations governing light sport aircraft. Similar to the membership of the Part 23…, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler; Phone: 610-832-9603; bschindl@astm.org R elease #9242
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ASTM International, in support of efforts stemming from the Part 23 Reorganization Aviation Rulemaking Committee (ARC), will host an organizational meeting for the establishment of a new ASTM standards activity on general aviation (GA) airworthiness design standards. The meeting will be held Sept. 17, from 1:00 p.m. to 4:00 p.m. EST, at the Aircraft Electronics Association headquarters in Lee’s…, Next Meeting:, Sept. 17 at AEA headquarters and Oct. 26 in Atlanta, Ga., ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9277
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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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Halon 1211 is employed in hand-held fire extinguishers on civilian aircraft. A new ASTM International standard will be used to test Halon 1211 to ensure that the product will provide the required level of fire protection and is free of harmful impurities that could affect its safety in use. ASTM D7673 , Specification for Halon 1211, Bromochlorodifluoromethane (CF2BrCl), was developed by…, ASTM Committee D26 Next Meeting:, June 15, 2011, June Committee Week, Anaheim, Calif., Technical Contact:, Mark L. Robin, DuPont Fluoroproducts, Wilmington, Del., Phone: 302-999-5002; mark.l.robin@usa.dupont.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 #8791
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Producers of fluorocarbons are invited to join in the ongoing standards developing activities of ASTM International Committee D26 on Halogenated Organic Solvents and Fire Extinguishing Agents. The committee has recently approved a new standard, ASTM D7509 , Specification for Fluorocarbon Feedstock Grade Chloroform, under the jurisdiction of Subcommittee D26.08 on Halogenated Organics Used as…
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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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Finding ways to assure the quality and safe handling of fire extinguishing agents has led to the development of two new ASTM International standards, D 7323 , Practice for Handling, Transportation and Storage of IG-100 (Nitrogen), and D 7325 , Practice for Handling, Transportation and Storage of IG-541, N2, Ar, CO2. The new standards were developed by Subcommittee D26.09 on Fire Extinguishing…
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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…