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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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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 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…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has now approved its first practice. ASTM E 2474 , Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice. Practice E 2474 covers process design, which is integral to process…