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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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Bisphenol A, or BPA, is a high production volume chemical widely used in manufacturing polycarbonate plastics and epoxy resins that are used in many industries. Procedures described in a new ASTM International standard will be used for measuring BPA concentration in environmental media such as soils, sludges and biosolids. The new standard, ASTM D7858 , Test Method for Determination of Bisphenol…, ASTM Committee D34 Next Meeting:, Virtual meeting, Oct. 10-11, 2013, Technical Contact:, Lawrence Zintek, Ph.D., U.S. Environmental Protection Agency, Region 5 Chicago Regional Laboratory, Chicago, Ill., Phone: 312-886-2925; zintek.lawrence@epa.gov, 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 #9456
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A new ASTM subcommittee will develop proposed standards to analyze organic compounds discharged into sanitary sewers. Subcommittee D34.02 on Discharge of Organic Wastes into Sanitary Sewers is part of ASTM International Committee D34 on Waste Management . “Considering the need for low detection limits and measurements that would assure all of the compounds of interest have been measured, sanitary…, ASTM Committee D34 Next Meeting:, April 2-3, 2013, EPA Headquarters, Las Vegas, Nev., Technical Contact:, John E. Burnett, Department of Public Works of Baltimore County, Columbia, Md., Phone: 410-887-5488; jeburnett@baltimorecountymd, 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 #9331
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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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A new ASTM International standard will provide gasket manufacturers a test for measuring creep and compression that can be used for R&D and material comparisons, and as a quality assurance tool. ASTM F2837 , Test Method for Hot Compression Properties of Gasket Materials, was developed by Subcommittee F03.40 on Chemical Test Methods, under the jurisdiction of ASTM International Committee F03…, ASTM Committee F03 Next Meeting:, Oct 12-13, October Committee Week, San Antonio, Texas, Technical Contact:, James Lingenfelder, Gasket Resources Inc., Houston, Texas, Phone: 713-856-9445; jtling@durlon.com, ASTM Staff Contact:, Joseph Hugo, Phone: 610-832-9740; jhugo@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8695/Sept2010
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ASTM International Committee F03 on Gaskets has developed and approved a new standard that can be used to evaluate gasket materials covered by ASTM F104 , Classification System for Nonmetallic Gasket Materials. The new standard, F2716 , Practice for Comparison of Nonmetallic Flat Gaskets in High Pressure Saturated Steam, is under the jurisdiction of Subcommittee F03.10 on Composite Gaskets. ASTM…
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A new ASTM International standard responds to a recent emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments. The standard, ASTM E2614 , Guide for Evaluation of Cleanroom Disinfectants, was developed by Subcommittee E35.15 on Antimicrobial Agents, part of ASTM International Committee E35 on Pesticides and…
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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…
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products has developed a new standard that covers the life cycle of pharmaceutical and biopharmaceutical manufacturing systems. The new standard, E 2500 , Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, is under the jurisdiction of Subcommittee E55.03 on…