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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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Events Include USTDA-Sponsored Workshop, Rare Earth Materials Workshop and RoHS Roundtable, ASTM International Committee F40 on Declarable Substances in Materials conducted its biannual standards development meetings on March 10-11, 2014, at Thermo Fisher Scientific’s facilities in Shanghai, China. The meeting included both standards development work and special presentations. ASTM staff and F40 members participated in other events related to declarable substances in China, including…, F40 Meeting, Committee F40 is currently developing three proposed new standards, which were discussed in the Shanghai meeting: • ASTM WK26792, Guide for Identification of Declarable Substances in Polymeric Materials; • ASTM WK21957, Test Method for Identification and Quantification of Lead in Paint and Other Coatings Using Energy Dispersive X-Ray Spectrometry (EDXRF); and • ASTM WK44003, Test Method for…, New Chemical Substance Workshop, Members of F40 participated in the U.S.-China Provisions on the Environmental Administration of New Chemical Substances workshop held in Shanghai on March 12. The workshop was organized by ASTM International in cooperation with the American National Standards Institute on behalf of the U.S. Trade and Development Agency. More than 30 participants from different regions of China, as well as from…, Rare Earth Materials Workshop, On March 13, F40 held a Rare Earth Materials workshop. Gao Lan, secretary general, Standardization Administration of China’s TC229 on Rare Earth Metals, provided an overview of TC229’s work, while Taco van der Marten, chairman of ASTM Subcommittee F40.04 on Rare Earth Materials, described the history and current activities of the subcommittee. The workshop also featured a presentation by Kevin…, RoHS Roundtable, Alyson Fick, ASTM staff manager for F40, spoke at a March 17 event held by the American Chamber of Commerce, China division, in Beijing. The roundtable on restriction of hazardous substances (RoHS) standards provided the opportunity for China-based U.S.-funded companies to understand ASTM standards that consider RoHS issues. Also speaking at that roundtable were Weibing Xing, chief engineer,…, Sinopec Visit, In addition to the F40 meetings and events, Fick, along with ASTM China office representatives Liu Fei and Nancy Hu, visited the polymers and plastic building product division of Sinopec Petroleum in Beijing. This division uses many standards under the jurisdiction of ASTM International Committee D20 on Plastics . The ASTM staff provided an overview of ASTM and D20 to 20 attending engineers. A…, ASTM Committee F40 Next Meeting:, Nov. 12-14, 2014, New Orleans, La., ASTM Staff Contact:, Alyson Fick, Phone: 610-832-9710; afick@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9634
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ASTM Committee F40 on Declarable Substances in Materials will convene its next business meetings in the People’s Republic of China in March 2014. The four-day session will include participation from 20 to 25 international technical committee experts who represent global manufacturers of products that incorporate identified hazardous materials restricted by legislation. Representatives from 15…, F40.01 Test Methods:, The development of standard test methods related to declarable substances in materials and products to assist manufacturing supply chains in various industries with compliance requirements. Key standards include: • ASTM F2617 , Test Method for Identification and Quantification of Chromium, Bromine, Cadmium, Mercury and Lead in Polymeric Material Using Energy Dispersive X-Ray Spectrometry (EDXRF…, F40.02 Management Practices and Guides, : Establish standards for the management of information for the declaration via paper or electronic means of substances in materials. Key Standards include: • ASTM F2577 , Guide for Assessment of Materials and Products for Declarable Substances • ASTM F2931 , Guide for Analytical Testing of Substances of Very High Concern in Materials and Products, F40.03 Monitoring and Research of Legislation and Regulations, F40.04 Rare Earth Materials, : Development of standards for rare earth materials, with an initial focus on material recycling, reuse and recapture as well as physical characterization and terminology. Key Work Items include: • ASTM WK44003, Test Method for Identification and Quantification of Rare Earth Elements (REEs) in Rare Earth Materials (REMs) by X-Ray Fluorescence Spectrometry ASTM encourages all interested…, ASTM Committee F40 Next Meeting:, March 10-13, 2014, Shanghai, China, ASTM Staff Contact:, Alyson Fick, Phone: 610-832-9710; afick@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9545
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Rare earth elements and rare earth materials are common in a wide variety of products, from cell phones to electric cars and beyond. Thus, REEs and REMs have become a critical component in the economies of many developing countries. Specifications and test methods are needed to determine if the purchased quality of REEs and REMs meets the specified quality. One such proposed standard is ASTM…, ASTM Committee F40 Next Meeting:, March 10-13, 2014, Shanghai, China, Technical Contact:, Taco van der Maten, PANalytical, Almelo, The Netherlands, Phone: +31-546-534-372; taco.van.der.maten@panalytical.com, ASTM Staff Contact:, Alyson Fick, Phone: 610-832-9710; afick@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9527
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As rare earth materials play an increasingly critical role in the growth of global industries, an ASTM International subcommittee is gearing up to address challenges across the life cycle of these vital resources. ASTM Subcommittee F40.04 on Rare Earth Materials held its most recent meeting in April and has established a standards development agenda aimed at supporting efficient and safe…, Stimulating the Worldwide Supply Chain, The increased demand for rare earth materials has converged with supply bottlenecks, resulting in a looming shortage of these resources throughout the worldwide high-tech, energy and automotive sectors. To better ensure that rare earths are more readily available for industry use, public and private sector stakeholders are focusing on ways to diversify supplies. Strategies include improving…, Protecting Our Energy Future, Underscoring the importance of rare earth materials to clean energy growth, the U.S. Department of Energy has established the Critical Materials Institute (CMI) at its Ames Laboratory in Ames, Iowa. The institute will bring together leading experts from academia, national laboratories and the private sector to find solutions to help avoid a rare earth supply shortage. Dr. Alex King, director of…, ASTM Committee F40 Next Meeting:, Nov. 13-14, 2013, November Committee Week, Jacksonville, Fla., Technical Contact:, Taco van der Maten, PANalytical B.V., Almelo, The Netherlands, Phone: +31-546-534-372; taco.van.der.maten@panalytical.com, ASTM Staff Contact:, Alyson Fick, Phone: 610-832-9710; afick@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9406
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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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Public policy decisions on rare earth materials will have an influence on industry and affect future standardization efforts. Acknowledging this importance, ASTM International Committee F40 on Declarable Substances in Materials has formed a new subcommittee, F40.04 on Rare Earth Materials. The subcommittee, which will promote knowledge, stimulate research and implement technology through the…, ASTM Committee F40 Next Meeting:, Nov. 14-15, 2012, November Committee Week, Atlanta, Ga., Technical Contact:, Taco van der Maten, PANalytical B.V., Almelo, The Netherlands, Phone: +31-546-534-372; taco.van.der.maten@panalytical.com, ASTM Staff Contact:, Alyson Fick, Phone: 832-9710; afick@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9309
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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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ASTM International Committee E21 on Space Simulation and Applications of Space Technology is requesting input on upcoming revisions for two standards under the jurisdiction of Subcommittee E21.05 on Contamination . The two standards to be revised are ASTM F21 , Test Method for Hydrophobic Surface Films by the Atomizer Test, and ASTM F22 , Test Method for Hydrophobic Surface Films by the Water-…