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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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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…
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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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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…
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Since 1998, when ASTM International Committee F05 on Business Imaging Products first approved standard F 1856 , Practice for Determining Toner Usage for Printer Cartridges, there has been a rapid increase in the use of color in office printing. In order to address this important change, Subcommittee F05.04 on Electrostatic Imaging Products has developed F 2632 , Practice for Determining the Toner…