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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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A new ASTM International standard will provide gasket manufacturers a test for measuring creep and compression that can be used for R&D and material comparisons, and as a quality assurance tool. ASTM F2837 , Test Method for Hot Compression Properties of Gasket Materials, was developed by Subcommittee F03.40 on Chemical Test Methods, under the jurisdiction of ASTM International Committee F03…, ASTM Committee F03 Next Meeting:, Oct 12-13, October Committee Week, San Antonio, Texas, Technical Contact:, James Lingenfelder, Gasket Resources Inc., Houston, Texas, Phone: 713-856-9445; jtling@durlon.com, ASTM Staff Contact:, Joseph Hugo, Phone: 610-832-9740; jhugo@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8695/Sept2010
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ASTM grain size is a property written into many specifications for metals, with finer grain sizes generally indicating better mechanical properties, such as formability. While measuring certain materials for such properties can be difficult, electron backscatter diffraction can provide precise determinations as well as give information on grain size distribution and statistics. A new ASTM…
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A recent revision to ASTM International standard E384 , Test Method for Knoop and Vickers Hardness of Materials, expands the range of its coverage. The standard is under the jurisdiction of Subcommittee E04.05 on Microindentation Hardness Testing, part of ASTM International Committee E04 on Metallography. The revision incorporates ASTM E92 , Test Method for Vickers Hardness of Metallic Materials…
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ASTM International Committee F03 on Gaskets has developed and approved a new standard that can be used to evaluate gasket materials covered by ASTM F104 , Classification System for Nonmetallic Gasket Materials. The new standard, F2716 , Practice for Comparison of Nonmetallic Flat Gaskets in High Pressure Saturated Steam, is under the jurisdiction of Subcommittee F03.10 on Composite Gaskets. ASTM…
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A new ASTM International standard responds to a recent emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments. The standard, ASTM E2614 , Guide for Evaluation of Cleanroom Disinfectants, was developed by Subcommittee E35.15 on Antimicrobial Agents, part of ASTM International Committee E35 on Pesticides and…
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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 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…