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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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Three proposed ASTM International standards will provide a base for the evaluation of the antimicrobial efficacy of solid copper materials. The proposed standards are being developed by Subcommittee B05.06, Methods of Test, part of ASTM International Committee B05 on Copper and Copper Alloys . The three proposed standards are: • ASTM WK42235 , Test Method for Efficacy of Copper Alloy Surfaces as…, ASTM Committee B05 Next Meeting:, Oct. 21-23, 2013, October Committee Week, Jacksonville, Fla., Technical Contact:, James H. Michel, Copper Development Association Inc., New York, N.Y., Phone: 212-251-7210; j ames.michel@copperalliance.us, ASTM Staff Contact:, Jennifer Rodgers, Phone: 610-832-9694; jrodgers@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9439
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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 new ASTM International standard sets quality requirements for the manufacture, documentation and records retention for light sport aircraft designed to ASTM consensus standards. ASTM F2972 , Specification for Light Sport Aircraft Manufacturer’s Quality Assurance System, was developed by Subcommittee F37.70 on Cross Cutting , part of ASTM International Committee F37 on Light Sport Aircraft .…, ASTM Committee F37 Next Meeting:, April 22-23, 2013, Messe Friedrichshafen GmbH, Friedrichshafen, Germany, Technical Contact:, Adam J. Morrison, Streamline Designs LLC, Greenwood, Ind., Phone: 317-888-1026; adam.morrison@sportplanedesign.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 #9315
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A newly approved ASTM copper standard focuses on the mechanical properties of machining brasses. ASTM B981/B981M , Specification for Low Leaded Brass Rod, Bar and Shapes, was developed by Subcommittee B05.02 on Rod, Bar, Wire, Shapes and Forgings , part of ASTM International Committee B05 on Copper and Copper Alloys . “Since 1997, there has been increasing legislation, regulation and voluntary…, ASTM Committee B05 Next Meeting:, April 15-17, 2013, April Committee Week, Indianapolis, Ind., Technical Contact:, Larry Muller, Chase Brass and Copper Co., Montpelier, Ohio, Phone: 419-485-8932; lmuller@chasebrass.com, ASTM Staff Contact:, Jennifer Rodgers, Phone: 610-832-9694; jrodgers@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9307
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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 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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Halon 1211 is employed in hand-held fire extinguishers on civilian aircraft. A new ASTM International standard will be used to test Halon 1211 to ensure that the product will provide the required level of fire protection and is free of harmful impurities that could affect its safety in use. ASTM D7673 , Specification for Halon 1211, Bromochlorodifluoromethane (CF2BrCl), was developed by…, ASTM Committee D26 Next Meeting:, June 15, 2011, June Committee Week, Anaheim, Calif., Technical Contact:, Mark L. Robin, DuPont Fluoroproducts, Wilmington, Del., Phone: 302-999-5002; mark.l.robin@usa.dupont.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 #8791