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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 International Committee E21 on Space Simulation and Applications of Space Technology is requesting input on upcoming revisions for two standards under the jurisdiction of Subcommittee E21.05 on Contamination . The two standards to be revised are ASTM F21 , Test Method for Hydrophobic Surface Films by the Atomizer Test, and ASTM F22 , Test Method for Hydrophobic Surface Films by the Water-…
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Owners and specifiers of steel building projects will be the primary users of a new ASTM International standard, ASTM A1068 , Practice for Life-Cycle Cost Analysis of Corrosion Protection Systems on Iron and Steel Products. The new standard was developed by Subcommittee A05.13 on Structural Shapes and Hardware Specifications, part of ASTM International Committee A05 on Metallic-Coated Iron and…
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Subcommittee A05.13 on Structural Shapes and Hardware Specifications is currently working on proposed new standards that would be used by engineers and architects who design with steel fabrications. These proposed standards will be used to evaluate the costs of steel construction over the lifetime of a project and to compare different corrosion protection systems on their impact to this lifetime…
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ASTM International Committee A05 on Metallic-Coated Iron and Steel Products has approved a new standard, ASTM A1059/A1059M , Specification for Zinc Alloy Thermo-Diffusion Coatings (TDC) on Steel Fasteners, Hardware and Other Products. The new standard is under the jurisdiction of Subcommittee A05.13 on Structural Shapes and Hardware Specifications. The technology described in ASTM A1059/A1059M…
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Galvanized steel products are manufactured and used throughout the world. A new ASTM International standard, A1057/A1057M , Specification for Steel, Structural Tubing, Cold Formed, Welded, Carbon, Zinc-Coated (Galvanized) by the Hot-Dip Process, addresses the galvanizing process as it is used across a variety of industries, including construction, automotive and transportation. The new standard…
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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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ASTM International Committee A05 on Metallic-Coated Iron and Steel Products will host a workshop, Hazardous Substances Affecting Metallic-Coated Steel and Other Metals, on May 23, 2007, during ASTM Committee Week in Norfolk, Va. The workshop will begin at 8:00 a.m. The topic will be the European Parliament and Council Directive on the Restrictions and use of certain Hazardous Substances in…