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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-…
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ASTM International Committee F37 on Light Sport Aircraft will host the International Workshop on Electric Aircraft Standardization on March 28 at the Hilton Garden Inn in Lakeland, Fla. The workshop is being held in conjunction with Committee F37’s standards development meetings at the 38th Annual SUN ‘n FUN International Fly-In and Expo. The marketplace adoption of electric aircraft requires…
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On July 29, 2011, the U.S. Federal Aviation Administration announced in the Federal Register the availability of ASTM International standard F2746–09 , Specification for Pilot’s Operating Handbook (POH) for Light Sport Airplane, as well as ASTM F2245-10c , Specification for Design and Performance of a Light Sport Airplane. Manufacturers of fixed wing light sport aircraft are required to revise…
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A new ASTM International standard will be used to aid in the creation of auditing programs within the light sport aircraft industry. ASTM F2839 , Practice for Compliance Audits to ASTM Standards on Light Sport Aircraft, was developed by Subcommittee F37.70 on Cross Cutting , part of ASTM International Committee F37 on Light Sport Aircraft . The new practice specifies the minimum methods and…
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ASTM International has published a new American National Standard, ASTM E2659 , Standard Practice for Certificate Programs. This standard provides much-needed guidance to certificate issuers on how to develop a quality certificate program and to consumers on how to identify such a program. In addition, the standard is designed to serve as the benchmark of quality for industry accreditation of…
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ASTM International Committee F37 on Light Sport Aircraft is currently at work on a proposed new standard that will aid light sport aircraft manufacturers in understanding the standardization system that governs their products. ASTM WK22124 , Guide for Compliance with Light Sport Airplane Standards, is under the jurisdiction of the F37.20 Airplane subcommittee. According to Thomas Gunnarson, U.S.…
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ASTM International Committee F37 on Light Sport Aircraft will meet March 30 to April 1, 2009, at the Messe Friedrichshafen Exhibition Grounds in Friedrichshafen, Germany, in conjunction with AERO Friedrichshafen 2009. The three days of F37 technical meetings will include discussions on changes to key LSA standards and proposals for new documents. It will also include several other activities,…
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All interested parties are invited to attend the first meeting of ASTM International Subcommittee E36.30 on Personnel Certificate Programs on June 23 at the Hyatt Regency Convention Center in Denver, Colo. The new subcommittee is part of ASTM International Committee E36 on Laboratory and Inspection Agency Accreditation, which will be meeting in Denver June 23-24. ASTM Subcommittee E36.30 will…
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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…