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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 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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An important ASTM engine coolant standard, ASTM D3321 , Test Method for Use of the Refractometer for Field Test Determination of the Freezing Point of Aqueous Engine Coolants, has recently been revised to reflect advances in engine coolant technology used in modern engines. ASTM D3321 is under the jurisdiction of Subcommittee D15.03 on Physical Properties , part of ASTM International Committee…, ASTM Committee D15 Next Meeting:, May 21-22, 2013, May Committee Week, Indianapolis, Ind., Technical Contact:, Frederick C. Alverson, Shell Global Solutions, Houston, Texas, Phone: 281-544-9217; frederick.alverson@shell.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 R elease #9274
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A new ASTM International standard provides a variety of recommendations for the manufacture and selection of digital thermometers. ASTM E2877 , Guide for Digital Contact Thermometers, was developed by Subcommittee E20.09 on Digital Contact Thermometers , part of ASTM International Committee E20 on Temperature Measurement . Included in ASTM E2877 is a set of accuracy classes for digital…, ASTM Committee E20 Next Meeting:, May 20-21, 2013, May Committee Week, Indianapolis, Ind., Technical Contact:, Christopher W. Meyer, National Institute of Standards and Technology, Gaithersburg, Md., Phone: 301-975-4825; cmeyer@nist.gov, 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 #9275
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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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Producers that perform verification testing of thermocouples and thermocouple components, along with those who write thermocouple product specifications, will be the primary users of a newly approved standard, ASTM E2820 , Test Method for Evaluating Thermal EMF Properties of Base-Metal Thermocouple Connectors. The new standard is under the jurisdiction of Subcommittee E20.04 on Thermocouples ,…