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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 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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X-ray diffraction has become a popular means of residual stress measurement in the aerospace materials field over the last 50 years. A proposed new guide being developed by ASTM International Committee E28 on Mechanical Testing will provide the necessary information to obtain the most reliable residual stress values as well as identify and evaluate potential errors in measurement, paving the way…
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Engineers and researchers who have specialized Charpy testing needs will be the primary users of two new standards recently approved by ASTM International Committee E28 on Mechanical Testing. The new standards, E2248 , Test Method for Impact Testing of Miniaturized Charpy V-Notch Specimens, and E2298 , Test Method for Instrumented Impact Testing of Metallic Materials, were developed by…
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ASTM International has published a new American National Standard, ASTM E2659 , Standard Practice for Certificate Programs. This standard provides much-needed guidance to certificate issuers on how to develop a quality certificate program and to consumers on how to identify such a program. In addition, the standard is designed to serve as the benchmark of quality for industry accreditation of…
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Working toward a standard practice for torque calibration that would reduce laboratory inconsistencies and uncertainties has led to the approval of a new ASTM International standard, E2428 , Practice for Calibration of Torque-Measuring Instruments for Verifying the Torque Indication of Torque Testing Materials. The new standard was developed by Subcommittee E28.01 on Calibration of Mechanical…
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All interested parties are invited to attend the first meeting of ASTM International Subcommittee E36.30 on Personnel Certificate Programs on June 23 at the Hyatt Regency Convention Center in Denver, Colo. The new subcommittee is part of ASTM International Committee E36 on Laboratory and Inspection Agency Accreditation, which will be meeting in Denver June 23-24. ASTM Subcommittee E36.30 will…
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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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ASTM International standards E 10 , Test Method for Brinell Hardness of Metallic Materials, and E 18 , Test Methods for Rockwell Hardness of Metallic Materials, have both recently undergone extensive revisions. Both standards are under the jurisdiction of Subcommittee E28.06 on Indentation Hardness Testing, which is part of ASTM International Committee E28 on Mechanical Testing. “The intention…