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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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Performance tests of potential personnel are becoming more commonly used as predictors of on-the-job performance. A new ASTM International standard is focused on 42 issues that are specific to personnel performance test development and implementation. ASTM E2849 , Practice for Professional Certification Performance Testing, was developed by Subcommittee E36.80 on Personnel Performance Testing and…, ASTM Committee E36 Next Meeting:, June 23-24, 2014, June Committee Week, Toronto, Ontario, Canada, Technical Contact:, Wallace Judd, CertNT LLC, Leesburg, Va, Phone: 703-884-2222 (ext. 802); wallace@wallacejudd.com, ASTM Staff Contact:, Rick Lake, Phone: 610-832-9689; rlake@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9565
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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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ASTM International has published a new American National Standard, ASTM E2659 , Standard Practice for Certificate Programs. This standard provides much-needed guidance to certificate issuers on how to develop a quality certificate program and to consumers on how to identify such a program. In addition, the standard is designed to serve as the benchmark of quality for industry accreditation of…