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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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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 continuing interest among road authorities to improve highway safety has led to efforts to improve wet-night visibility of pavement markings, including a new ASTM International standard. ASTM E2832 , Test Method for Measuring the Coefficient of Retroreflected Luminance of Pavement Markings in a Standard Condition of Continuous Wetting (RL-2), was developed by Subcommittee E12.10 on…, ASTM Committee E12 Next Meeting:, Jan. 30-31, 2013, January committee week, Jacksonville, Fla., Technical Contact:, Paul Carlson, Texas Transportation Institute, College Station, Texas, Phone: 979-845-6004; paul-carlson@tamu.edu, ASTM Staff Contact:, Thomas O’Toole, Phone: 610-832-9739; totoole@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9243
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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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A request from the United States Navy was the impetus behind the development of a new ASTM International standard, E2630 , Test Method for Luminance Ratio of a Fluorescent Specimen Using a Narrow Band Source. The new standard was developed by Subcommittee E12.05 on Fluorescence, part of ASTM International Committee E12 on Color and Appearance. Richard Harold, consultant, Color and Appearance…
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First generation gonioapparent colorants are materials pigmented with metal flakes that change lightness as illumination angles change. Used heavily in automotive coatings, the first generation of gonioapparent materials was covered by ASTM International standard E2194 , Practice for Multiangle Color Measurement of Metal Flake Pigmented Materials, first published in 2003. Now, a second generation…
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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 E12 on Color and Appearance has approved a new standard that describes techniques for planning and analyzing the results of an interlaboratory study conducted for certain test methods within E12. E 2480 , Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method with Multi-Valued Measurands, is under the jurisdiction of Subcommittee…
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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…