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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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A proposed new ASTM International standard will provide an up-to-date method for the aluminum industry to analyze samples by inductively coupled plasma-atomic emission spectroscopy. The proposed new standard, WK35993 , Test Method for Analysis of Aluminum and Aluminum Alloys by Inductively Coupled Plasma Atomic Emission Spectrometry (Performance Based Method), is being developed by Subcommittee…
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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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ASTM Committee E10 on Nuclear Technology and Applications has approved two new ASTM standards, ASTM E2628 , Practice for Dosimetry for Radiation Processing, and ASTM E2701 , Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing. Both standards are under the jurisdiction of Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications…, ASTM Committee E10 Next Meeting:, Jan. 24-27, January committee week, San Antonio, Texas, Technical Contact:, (E2628) John Logar, Ethicon Inc., Somerville, N.J., Phone: 908-218-5638; jlogar8@its.jnj.com ; (E2701) Rod Chu, Ottawa, Ontario, Canada, Phone: 613-565-2305; rodchu@rogers.com, ASTM Staff Contact:, Joe Koury, Phone: 610-832-9804; jkoury@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #84 58/Jan2010
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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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A proposed new standard is being developed for the industrial radiation processing industry and irradiation research facilities where absorbed-dose measurement is critical. The proposed standard, WK15409 , Practice for Dosimetry in Radiation Processing, is under the jurisdiction of Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications, which is part of ASTM International…
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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…