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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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A new ASTM International standard will provide the means to quickly detect and quantify the lead concentration in toys and other children's products. The new standard, F2853 , Test Method for Determination of Lead in Paint Layers and Similar Coatings or in Substrates and Homogenous Materials by Energy Dispersive X-Ray Fluorescence Spectrometry Using Multiple Monochromatic Excitation Beams, was…
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A newly approved ASTM International standard will advance the cause of architectural preservation. The new standard, ASTM C1713 , Specification for Mortars for the Repair of Historic Masonry, was developed by Subcommittee C12.03 on Specifications for Mortars, part of ASTM International Committee C12 on Mortars and Grouts for Masonry Units. John Wathne, structural engineer and president of…
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The presence of lead in toys and other consumer products continues to make headlines. The Consumer Product Safety Improvement Act, a United States law enacted in August 2008, addresses the lead issue and makes provisions for the use of X-ray spectrometry in testing for lead content. To aid the toy and consumer products industries in using X-ray spectrometry for lead detection and meet the…
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ASTM International Committee F40 on Declarable Substances in Materials has approved its first test method, F2617 , Test Method for Identification and Quantification of Chromium, Bromine, Cadmium, Mercury and Lead in Polymeric Material Using Energy Dispersive X-ray Spectrometry. The new standard is under the jurisdiction of Subcommittee F40.01 on Test Methods. ASTM F2617 describes a method for…
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A new ASTM International standard will assist industry with a communication tool in order to comply with the European Union's Registration, Evaluation and Authorization of Chemicals, more commonly referred to as REACH. ASTM F2725, Standard Guide for European Union's Registration, Evaluation and Authorization of Chemicals (REACH) Supply Chain Information Exchange, was developed by Subcommittee F40…