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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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Increasing interest in the various uses of electrical contacts is the leading impetus for the development of a proposed new standard, ASTM WK34423 , Specification for Electrodeposited Coatings of Palladium-Cobalt Alloy for Engineering Use. The proposed standard is being developed by Subcommittee B08.08 on Metallic Coatings , part of ASTM International Committee B08 on Metallic and Inorganic…, ASTM Committee B08 Next Meeting:, May 10, 2012, May Committee Week, Phoenix, Ariz., Technical Contact:, Sheikh H. Rahman, Lean Corp., Southfield, Mich., Phone: 248-447-1526; srahman@lear.com, ASTM Staff Contact:, Diane Trinsey, Phone: 610-832-9661; dtrinsey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9016
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Three-dimensional laser scanning is a maturing technology that holds great promise for capturing highly accurate information about an object or scene by collecting millions of dense measurements very quickly. ASTM International Committee E57 on 3D Imaging Systems is developing new standards for this technology, including ASTM E2807 , Specification for 3D Imaging Data Exchange, Version 1.0. ASTM…
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A new task group within ASTM Committee E57 on 3D Imaging Systems plans to develop standards on position and orientation (pose) determination that could help increase productivity and enhance the global competitiveness of the U.S. manufacturing industry. The task group, under the jurisdiction of Subcommittee E57.02 on Test Methods, is currently working on its first proposed new standard, ASTM…
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A new ASTM subcommittee seeks to acknowledge the ongoing advances being made in the field of nanostructured inorganic coatings. B08.16 on Nanostructured Coatings, part of ASTM International Committee B08 on Metallic and Inorganic Coatings, is currently developing its first proposed standard, ASTM WK29468 , Specification for Galvanic Protection of Steel Using a Nanostructured Coating of 95 % Zinc…
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Three-dimensional laser scanning is an emerging technology that holds great promise for capturing dimensionally accurate information about an object or scene by collecting millions of dense measurements very quickly. ASTM International Committee E57 on 3D Imaging Systems is developing new standards for this technology, including ASTM E2761, Specification for 3D Imaging Data Exchange. ASTM E2761,…
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Three dimensional image system technology is now used in a wide variety of industries, including construction, mapping, manufacturing, mining and forensics. For all of these industries, safe usage of 3D imaging equipment is a top priority. However, until the approval of a new ASTM International standard, no safety guidelines specifically oriented toward 3D image system technology existed. The…
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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…