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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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ASTM International recently developed its, Roadmap in Support of Commercial Nuclear Power, to provide a practical set of plans for updating ASTM nuclear energy standards in conjunction with the Nuclear Energy Standards Coordination Collaborative (NESCC). The ultimate goal of the roadmap, a document that spells out these plans in detail, is to ensure a safe and economical source of electricity for now and in the future. A link to the Roadmap can be found in the ASTM Nuclear Portal at…, Technical Contact:, Stephen Byrne, Phone: 860-342-7363; pnsbyrne@yahoo.com, ASTM Staff Contact:, Joe Koury, Phone: 610-832-9804; jkoury@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9321
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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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ASTM Committee E61 to Maintain and Develop International Standards, ASTM International, one of the largest voluntary standards development organizations in the world, has announced that ASTM Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications has been reorganized as ASTM Committee E61 on Radiation Processing . The new main committee will revise and maintain the existing Subcommittee E10.01 standards and will develop new standards that cover…, ASTM Committee E61 Next Meeting:, Jan. 27-29, 2013, Jacksonville, Fla., ASTM Staff Contact:, Joseph Koury, Phone: 610-832-9804; jkoury@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9231
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New ASTM Nuclear Fuel Cycle Standard Provides Guidelines for Gathering Physical and Rheological DataObtaining data from the measurement and calculation of physical and rheological properties of radioactive solutions, slurries and sludges is essential in developing appropriate simulants for the design and testing of retrieval, transport, mixing and storage systems for treating radioactive materials. A new ASTM International standard provides guidelines for gathering this data. ASTM C1752 , Guide…
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New Section of Website Collects ASTM Nuclear-Related Work in a Single Source ASTM International standards play an important role throughout the nuclear energy industry. In order to tie together the nuclear-related activity being conducted across its committees, ASTM has added a nuclear portal to its website ( www.astm.org ). The portal, which gathers together all of ASTM’s standards developing…
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Invented in the early 1990s, the tomographic gamma scanner is used in the nondestructive assay of radioactive waste contained in drums or cans. In the last 10 years, TGS technology has been industrialized, with systems operating in South Korea, the United States and Europe. A new ASTM International test provides users with a means of streamlining TGS procedures and practices, and it will be…
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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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In response to requests from fuel producers around the world, ASTM International Committee C26 on Nuclear Fuel Cycle has developed a standard for using the total evaporation method to determine uranium or plutonium composition. The new standard, C 1672 , Test Method for Determination of Uranium or Plutonium Isotopic Composition or Concentration by the Total Evaporation Method Using a Thermal…
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Neutron absorbers have been used for criticality control in spent nuclear fuel pools and in spent fuel transportation casks for decades. However, since the late 1980s, as spent fuel storage pools have been filled, utilities have transferred spent fuel into dry dual-purpose (storage/transportation) canisters. The neutron absorbers used in dual-purpose canisters are subjected to different operating…