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ASTM International and the Parenteral Drug Association recently signed a Memorandum of Understanding that launches a pilot to streamline efforts and conserve resources as both organizations develop technical guidance for the pharmaceutical industry. Katharine Morgan, executive vice president, ASTM, and Richard M. Johnson, president, PDA, signed the MOU. “The MOU between ASTM International and PDA…, ASTM Committee E55 on Manufacture of Pharmaceutical Products Next Meeting:, April 28-30, 2015, Lisbon, Portugal, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #9815 ###
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Ingot producers, forge shops and titanium service centers that hold ingot for conversion by contract forge shops will be the primary users of a proposed new ASTM International standard from Committee B10 on Reactive and Refractory Metals and Alloys . ASTM WK42957 , Specification for Titanium and Titanium Alloy Forging Stock, is being developed by Subcommittee B10.01 on Titanium . According to…, ASTM Committee B10 Next Meeting:, May 6-7, 2014, May Committee Week, Toronto, Ontario, Canada, Technical Contact:, James A. McMaster, MC Consulting, Huletts Landing, N.Y., Phone: 518-499-0331; jimmcmaster@msn.com , ASTM Staff Contact:, Jeffrey Adkins, Phone: 610-832-9738; jadkins@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9628
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A new ASTM International standard will be used to quantitatively test the ability of a trace detector to reliably sense and identify very small amounts of explosives. ASTM E2677 , Test Method for Determining Limits of Detection in Explosive Trace Detectors, was developed by Subcommittee E54.01 on CBRNE Sensors and Detectors , part of ASTM International Committee E54 on Homeland Security…, ASTM Committee E54 Next Meeting:, May 28-30, 2014, National Institute of Standards and Technology, Gaithersburg, Md., Technical Contact:, Michael Verkouteren, National Institute of Standards and Technology, Gaithersburg, Md., Phone: 301-975-3933; m.verkouteren@nist.gov, ASTM Staff Contact:, Rick Lake, Phone: 610-832-9689; rlake@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9629
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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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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…