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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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Non-destructive moisture meters are now widely used in determining moisture levels in concrete, gypsum concrete and other types of floor slabs. A new ASTM International standard qualifies the types of meter suitable for this purpose and provides guidelines for how, where and when such moisture meters are used and what limitations exist. The new standard, ASTM F2659 , Guide for Preliminary…, ASTM Committee F06 Next Meeting:, Nov. 10-11, New Orleans, La., Technical Contact:, Sean Fallon, Dublin, Ireland, Phone: +011-353-1-285-1861; seanfallon@ireland.com, ASTM Staff Contact:, Stephen Mawn, Phone: 610-832-9726; smawn@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #870/Oct2010
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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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A new standard approved by ASTM International Committee B07 on Light Metals and Alloys provides an outline for designers, casting purchasers, casting producers and technical societies on how to do business when purchasing squeeze, thixocast or rheocast parts. The new standard, B969 , Specification for Aluminum-Alloy Castings Produced by the Squeeze Casting, Thixocast and Rheocast Semi-Solid…
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Special considerations need to be made for flooring in multi-purpose rooms, particularly those in child care buildings, elementary schools and long-term care facilities. ASTM International Committee F06 on Resilient Floor Coverings is currently developing a proposed new standard for such flooring. WK24836 , Specification for Active Area, Multipurpose Flooring, is under the jurisdiction of…
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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…