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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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While the quality of coating materials for buried pipe at nuclear power plants has evolved over time, there is currently no written standard that would allow plants to fully take advantage of advances in coating technology. A proposed new standard will provide coating guidance for plants seeking to repair or replace buried pipe. The proposed standard, ASTM WK36282 , Guide for Selection of Coating…
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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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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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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…
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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…