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ASTM International Committee E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document a set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds. The proposed standard, ASTM WK39883 , Practice for Process of Inactivation of Enveloped…, ASTM Committee E55 Next Meeting:, April 9-11, 2013, Genzyme-A Sanofi Company, Haverhill, Suffolk, United Kingdom, Technical Contact:, John Schreffler, Ph.D., Morphotek Inc., Exton, Pa., Phone: 610-423-6557; jschreffler@morphotek.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9327
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A new ASTM International standard provides a variety of recommendations for the manufacture and selection of digital thermometers. ASTM E2877 , Guide for Digital Contact Thermometers, was developed by Subcommittee E20.09 on Digital Contact Thermometers , part of ASTM International Committee E20 on Temperature Measurement . Included in ASTM E2877 is a set of accuracy classes for digital…, ASTM Committee E20 Next Meeting:, May 20-21, 2013, May Committee Week, Indianapolis, Ind., Technical Contact:, Christopher W. Meyer, National Institute of Standards and Technology, Gaithersburg, Md., Phone: 301-975-4825; cmeyer@nist.gov, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9275
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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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Increasing interest in the various uses of electrical contacts is the leading impetus for the development of a proposed new standard, ASTM WK34423 , Specification for Electrodeposited Coatings of Palladium-Cobalt Alloy for Engineering Use. The proposed standard is being developed by Subcommittee B08.08 on Metallic Coatings , part of ASTM International Committee B08 on Metallic and Inorganic…, ASTM Committee B08 Next Meeting:, May 10, 2012, May Committee Week, Phoenix, Ariz., Technical Contact:, Sheikh H. Rahman, Lean Corp., Southfield, Mich., Phone: 248-447-1526; srahman@lear.com, ASTM Staff Contact:, Diane Trinsey, Phone: 610-832-9661; dtrinsey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9016
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Producers that perform verification testing of thermocouples and thermocouple components, along with those who write thermocouple product specifications, will be the primary users of a newly approved standard, ASTM E2820 , Test Method for Evaluating Thermal EMF Properties of Base-Metal Thermocouple Connectors. The new standard is under the jurisdiction of Subcommittee E20.04 on Thermocouples ,…
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A new ASTM subcommittee seeks to acknowledge the ongoing advances being made in the field of nanostructured inorganic coatings. B08.16 on Nanostructured Coatings, part of ASTM International Committee B08 on Metallic and Inorganic Coatings, is currently developing its first proposed standard, ASTM WK29468 , Specification for Galvanic Protection of Steel Using a Nanostructured Coating of 95 % Zinc…
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Providing practical advice on the use of infrared thermometers is the purpose of a proposed new ASTM International standard. Infrared thermometry is used in a variety of measurement applications, including heating, ventilating and air conditioning, building inspection, industrial and manufacturing, automotive and food service equipment. The proposed new standard, ASTM WK21204 , Guide for the…
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No industry standard currently exists that addresses the vacuum sealing requirements of knife-edged flanges for high vacuum applications. Existing international standards focus on interchangeability of the hardware, but do not address the reliability of the seal. ASTM International Committee E42 on Surface Analysis is now working on a proposed standard on the subject, WK21206 , Specification…
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A 2002 workshop on galling wear held by ASTM International Committee G02 on Wear and Erosion provided the impetus for the development of a new standard, ASTM G196 , Test Method for Galling Resistance of Material Couples. The new standard is under the jurisdiction of Subcommittee G02.40 on Non-Abrasive Wear. According to Scott Hummel, Ph.D., associate professor, head of the department 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…