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With support from industry and government leaders, ASTM International will host an organizational meeting to potentially create a new technical committee that develops voluntary consensus standards for commercial spaceflight. This meeting comes in part as a result of the updated U.S. Commercial Space Launch Competitiveness Act of 2015 (CSLCA). The U.S. Federal Aviation Administration’s…, ASTM Commercial Spaceflight Meeting:, Oct. 24, 2016, RTCA, Inc.; 1150 18th St. NW, 4th Floor, Washington, DC 20036, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #10170
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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 Technology and Underground Utilities Committee to Work on Proposed Standards at October MeetingASTM International Committee F36 on Technology and Underground Utilities is developing several proposed new standards. Two such standards are ASTM WK39910 , Practice for the Use of Distributed Optical Fiber Sensing for Monitoring Ground Movements Around Utilities and Tunnels, and ASTM WK41891 , Practice for the Full-Length Monitoring of the Interface Temperature of a Cured in Place Pipe Lining…, ASTM Committee F36 Next Meeting:, Oct. 6, 2013, in conjunction with the 86th Annual Water Environment Federation Technical Exhibition and Conference, Chicago, Ill., Technical Contact:, Jey K. Jeyapalan, Civic Enterprises LLC, New Milford, Conn., Phone: 860-343-1767; jkjeyapalan@earthlink.net , ASTM Staff Contact:, Ashley Wiand, Phone: 610-832-9551; awiand@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9448
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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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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 F36 on Technology and Underground Utilities invites all interested parties to participate in the standards developing activities of Subcommittee F36.60 on Infrastructure Asset Management. The subcommittee is currently developing its first standard. The new subcommittee was formed because the issue of asset management of underground assets of pipeline utilities has…
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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…
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Plastic pipe and components are used with low pressure oxygen and enriched air for a variety of applications, including medical and healthcare, agriculture (fish farming), welding and fabrication, waste water treatment and others. Despite this widespread use, there are currently no standards that help in the materials selection and design features of these systems. ASTM International Committee…
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The ASTM International committee formerly known as E55 on Pharmaceutical Application of Process Analytical Technology has undergone a change in title and scope that reflects the intent of the committee to be more inclusive of all the tools, instrumentation and sciences that might be used by the industry in the management of pharmaceutical manufacturing processes. The committee is now known as E55…