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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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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…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has now approved its first practice. ASTM E 2474 , Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice. Practice E 2474 covers process design, which is integral to process…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has created a new subcommittee, E55.03 on General Pharmaceutical Standards, which will address issues on quality within a broad framework of chemistry, manufacturing and control. The scope of the new subcommittee is the development of general principles, practices and related standards for managing…
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A proposed new standard currently being developed by ASTM International Committee F01 on Electronics will prove to be useful to the tantalum sputtering target industry. The proposed standard, WK9490, Test Method for Reporting Crystallographic Orientation of Sputtering Target Materials, is under the jurisdiction of Subcommittee F01.17 on Sputter Metallization. "The tantalum sputtering target…