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Yesterday, Dr. Sudarsan Rachuri was given the 2016 ASTM International President’s Leadership Award. This recognizes individuals early in their ASTM International career who have significantly advanced the organization's mission through extraordinary accomplishment, example, and vision. Rachuri is serving as Editor-in-Chief of ASTM International’s new journal, Smart and Sustainable Manufacturing…, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org Release #10176
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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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If a leather article such as a shoe or a glove were left next to a heater for an extended period of time, would the finish remain soft and flexible or would it change color and develop cracks within the leather finish? A new ASTM International standard will help to answer that question, giving manufacturers a clear method to predict and prevent such problems. ASTM D7912 , Test Method for…, Technical Contact:, Kadir Donmez, Leather Research Laboratory, University of Cincinnati, Cincinnati, Ohio, Phone: 513-242-6300; donmezk@uc.edu, ASTM Staff Contact:, Ashley Wiand, Phone: 610-832-9551; awiand@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9623
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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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Wet blue and wet white are intermediate products used by tanneries that process natural hides and skins into leather. Natural fats and oils need to be largely removed from wet blue and wet white for leather processing to be done properly, but no standard had previously existed to evaluate the effectiveness of such removal. ASTM International Committee D31 on Leather has now developed such a…
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During a virtual meeting on Oct. 28, Committee D32 held an ”open house” for potential new members. The open house featured an introduction to ASTM, an explanation of Committee D32’s mission, and highlights of the committee’s active task groups. A recording of this webinar can be viewed on Committee D32’s Web site. Founded in 1975, ASTM Committee D32 develops test methods, classifications,…
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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…