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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 new ASTM International standard provides a variety of recommendations for the manufacture and selection of digital thermometers. ASTM E2877 , Guide for Digital Contact Thermometers, was developed by Subcommittee E20.09 on Digital Contact Thermometers , part of ASTM International Committee E20 on Temperature Measurement . Included in ASTM E2877 is a set of accuracy classes for digital…, ASTM Committee E20 Next Meeting:, May 20-21, 2013, May Committee Week, Indianapolis, Ind., Technical Contact:, Christopher W. Meyer, National Institute of Standards and Technology, Gaithersburg, Md., Phone: 301-975-4825; cmeyer@nist.gov, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9275
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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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Producers that perform verification testing of thermocouples and thermocouple components, along with those who write thermocouple product specifications, will be the primary users of a newly approved standard, ASTM E2820 , Test Method for Evaluating Thermal EMF Properties of Base-Metal Thermocouple Connectors. The new standard is under the jurisdiction of Subcommittee E20.04 on Thermocouples ,…
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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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Providing practical advice on the use of infrared thermometers is the purpose of a proposed new ASTM International standard. Infrared thermometry is used in a variety of measurement applications, including heating, ventilating and air conditioning, building inspection, industrial and manufacturing, automotive and food service equipment. The proposed new standard, ASTM WK21204 , Guide for the…
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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…