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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 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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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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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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No industry standard currently exists that addresses the vacuum sealing requirements of knife-edged flanges for high vacuum applications. Existing international standards focus on interchangeability of the hardware, but do not address the reliability of the seal. ASTM International Committee E42 on Surface Analysis is now working on a proposed standard on the subject, WK21206 , Specification…
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A 2002 workshop on galling wear held by ASTM International Committee G02 on Wear and Erosion provided the impetus for the development of a new standard, ASTM G196 , Test Method for Galling Resistance of Material Couples. The new standard is under the jurisdiction of Subcommittee G02.40 on Non-Abrasive Wear. According to Scott Hummel, Ph.D., associate professor, head of the department of…
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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…