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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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ASTM International Committee F38 on Unmanned Aircraft Systems has approved seven new standards that cover all major facets of small unmanned aircraft systems operations, including design, construction, operation and maintenance requirements. The seven new ASTM standards, written for all sUAS that are permitted to operate over a defined area and in airspace defined by a nation’s governing aviation…, ASTM F2908, Specification for Aircraft Flight Manual (AFM) for a Small Unmanned Aircraft System (sUAS), − ASTM F2908 defines minimum requirements for the aircraft flight manual, which provides guidance to owners, mechanics, pilots, crew members, airports, regulatory officials and aircraft and component manufacturers who perform or provide oversight of sUAS flight operations. •, ASTM F2909, Practice for Maintenance and Continued Airworthiness of Small Unmanned Aircraft Systems (sUAS), − ASTM F2909 establishes a practice for the maintenance and continued airworthiness of sUAS. Requirements for continued airworthiness, inspections, maintenance and repairs/alterations are included. •, ASTM F2910, Specification for Design and Construction of a Small Unmanned Aircraft System (sUAS), − ASTM F2910 defines the design, construction and test requirements for sUAS. In addition to general requirements, ASTM F2910 covers requirements for structure, propulsion, propellers, fuel and oil systems, cooling, documentation and other key areas. •, ASTM F2911, Practice for Production Acceptance of Small Unmanned Aircraft System (sUAS), − ASTM F2911 defines production acceptance requirements for sUAS. Requirements covered include several aspects of production, system level production acceptance, quality assurance and documentation. •, ASTM F3002, Specification for Design of the Command and Control System for Small Unmanned Aircraft Systems (sUAS), − ASTM F3002 provides a consensus standard in support of an application to a nation’s governing aviation authority to operate an sUAS for commercial or public use. The standard focuses on command and control (C2) links, including a diagram of a C2 system and general requirements for C2 system components. •, ASTM F3003, Specification for Quality Assurance of a Small Unmanned Aircraft System (sUAS), − ASTM F3003 defines quality assurance requirements for design, manufacture and production of small unmanned aircraft systems. Guidance is given to sUAS manufacturers for the development of a quality assurance program. •, ASTM F3005, Specification for Batteries for Use in Small Unmanned Aircraft Systems (sUAS), − ASTM F3005 defines requirements for battery cells used in sUAS. Mechanical design and safety, and electrical design battery maintenance are primary battery-related areas that are covered. “The introduction of these standards developed by F38 will help to provide a safe and appropriate path for near-term routine sUAS operations in airspace systems of the United States and other countries,” says…, Technical Contact:, Theodore J. Wierzbanowski, Phone: 626-429-8864; wierzbanowski@uasinthenas.com, ASTM Staff Contact:, Stephen Mawn, Phone: 610-832-9726; smawn@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9636
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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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Increasing interest in the various uses of electrical contacts is the leading impetus for the development of a proposed new standard, ASTM WK34423 , Specification for Electrodeposited Coatings of Palladium-Cobalt Alloy for Engineering Use. The proposed standard is being developed by Subcommittee B08.08 on Metallic Coatings , part of ASTM International Committee B08 on Metallic and Inorganic…, ASTM Committee B08 Next Meeting:, May 10, 2012, May Committee Week, Phoenix, Ariz., Technical Contact:, Sheikh H. Rahman, Lean Corp., Southfield, Mich., Phone: 248-447-1526; srahman@lear.com, ASTM Staff Contact:, Diane Trinsey, Phone: 610-832-9661; dtrinsey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9016
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New regulations set forth by the U.S. Environmental Protection Agency to mandate greenhouse gas reporting in the U.S. carbon black industry have led to the development of a new ASTM International standard, ASTM D7662 , Test Method for Carbon Content in Carbon Black Feedstock Oils. ASTM D7662 is under the jurisdiction of Subcommittee D24.66 on Environment, Health and Safety, part of ASTM…
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A new ASTM subcommittee seeks to acknowledge the ongoing advances being made in the field of nanostructured inorganic coatings. B08.16 on Nanostructured Coatings, part of ASTM International Committee B08 on Metallic and Inorganic Coatings, is currently developing its first proposed standard, ASTM WK29468 , Specification for Galvanic Protection of Steel Using a Nanostructured Coating of 95 % Zinc…
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The U.S. Environmental Protection Agency has set forth new regulations that mandate greenhouse gas reporting in the U.S. carbon black industry. These regulations were the impetus for the development of a new ASTM International standard, ASTM D7633 , Test Method for Carbon Black Carbon Content. The new standard was developed by Subcommittee D24.66 on Environment, Health and Safety, part of ASTM…, ASTM Committee D24 Next Meeting:, Dec. 6-8, December Committee Week, New Orleans, La., Technical Contact:, George Joyce, Columbian Chemicals Co., Marietta, Ga., Phone: 770-792-9467; gjoyce@columbianchemicals.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 #8641
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As part of its ongoing work supporting the Federal Aviation Administration to develop a Special Federal Aviation Regulation for small Unmanned Aircraft Systems, ASTM International Committee F38 on Unmanned Air Vehicle Systems is currently working on a proposed registration and marking standard. ASTM WK27055 , Specification for the Registration and Marking of Unmanned Aircraft System, is under the…, Technical Contact:, Rocky Gmeiner, Raytheon Co., Arlington, Va.; Phone: 703-284-4308; regmeiner@raytheon.com, ASTM Staff Contact:, Daniel Schultz, Phone: 610-832-9716; dschultz@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8609
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ASTM International Committee F38 on Unmanned Aircraft Systems (UAS) was recently requested by the Federal Aviation Administration to assist with the development of industry consensus standards to support the integration of small unmanned aircraft systems (sUAS) into the U.S. national airspace system (NAS). Following a model that was successfully used for the integration of light sport aircraft…