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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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Purified terephthalic acid, often known simply as PTA, is in high demand as the key raw material for the manufacture of polyester fiber, resin and film. Two proposed ASTM standards are currently being developed that will be used to find major impurities in PTA product. The two proposed standards are ASTM WK36121 , Test Method for Determination of p-Toluic Acid and 4-Carboxybenzaldehyde in…, ASTM Committee D16 Next Meeting:, Jan. 30-31, 2013, January Committee Week, Jacksonville, Fla., Technical Contact:, Yuhong Zhang, China Petrochemical Corp., Shanghai, China, Phone: 011-86-21-68462281; zhangyh.sshy@sinopec.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 R elease #9266
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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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Manufacturers of toluene, mixed xylenes and p-xylene are often required to determine the type and amount of impurities that remain from manufacture. A new ASTM International standard, D7504 , Test Method for Trace Impurities in Monocyclic Aromatic Hydrocarbons by Gas Chromatography and Effective Carbon Number, can now be used as an internal quality control tool where these products are produced…
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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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Chemical plants and contract and research laboratories will all be likely users of a new ASTM International standard, D 7183 , Test Method for Determination of Total Sulfur in Aromatic Hydrocarbons and Related Chemicals by Ultraviolet Fluorescence. D 7183 was developed by Subcommittee D16.04 on Instrumental Analysis, part of ASTM International Committee D16 on Aromatic Hydrocarbons and Related…