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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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Since 2009, the National Fire Protection Association has required arc rated gloves in its NFPA70E, Standard for Electrical Safety in the Workplace. A new ASTM standard will now provide arc rating thermal protective values for gloves, which will allow more gloves to be used inside an arc flash zone when there is no shock hazard. The new standard, ASTM F2675/F2675M , Test Method for Determining Arc…, ASTM Committee F18 Next Meeting:, Oct. 20-23, 2013, Charleston, S.C., Technical Contact:, Hugh Hoagland, ArcWear, Louisville, Ky., Phone: 502-832-9737; hugh@arcwear.com , ASTM Staff Contact:, Kevin Shanahan, Phone: 610-832-9737, kshanahan@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9469
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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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An important ASTM engine coolant standard, ASTM D3321 , Test Method for Use of the Refractometer for Field Test Determination of the Freezing Point of Aqueous Engine Coolants, has recently been revised to reflect advances in engine coolant technology used in modern engines. ASTM D3321 is under the jurisdiction of Subcommittee D15.03 on Physical Properties , part of ASTM International Committee…, ASTM Committee D15 Next Meeting:, May 21-22, 2013, May Committee Week, Indianapolis, Ind., Technical Contact:, Frederick C. Alverson, Shell Global Solutions, Houston, Texas, Phone: 281-544-9217; frederick.alverson@shell.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 R elease #9274
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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 standard being developed by ASTM International Committee F18 on Electrical Protective Equipment for Workers will provide guidance to assist in the required testing of live-line tools. ASTM WK33590 , Guide for In-Service Inspection, Maintenance and Electrical Testing of Insulating Tools (Fiberglass-Reinforced Plastic (FPR) and Wooden Live-Line Tools), is under the jurisdiction of…
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ASTM International Committee D15 on Engine Coolants has formed three new subcommittees: Subcommittees D15.22 on Non-Aqueous Coolants ; D15.25 on Diesel Exhaust Fluid ; and D15.30 on Industrial Heat Transfer Fluids . All interested parties are invited to join in the standards developing activities of these new subcommittees., D15.22, Non-Aqueous Coolants, While there has been an increased interest in non-aqueous coolants industry, there are no current ASTM standards in this area. D15.22 will begin to develop such standards. “The envisioned standards for non-aqueous coolants would be performance standards, rather than ingredient standards, to allow for formulations that are not currently proprietary,” says Jonathan T. Light, chief engineer, Evans…, D15.25, Diesel Exhaust Fluid, Diesel exhaust fluid, often referred to as DEF, is required by many diesel engine-powered vehicles delivered after January 2010. More recent environmental standards issued by the U.S. Environmental Protection Agency have created more stringent emissions standards for agricultural, construction and forestry equipment. DEF is used to reduce nitrogen oxide emissions, which allows original equipment…, D15.30, Industrial Heat Transfer Fluids, Members of D15 recognized that changes in the antifreeze industry, including new manufacturing technologies, improved inhibitor chemistries and recycling technologies, would likely be adapted to the facilities industry as a natural course of innovation. Because D15 has experience developing standards that are technically similar to the facilities heat transfer industry, it was deemed appropriate…, ASTM Committee D15 Next Meeting:, May 17-18, May Committee Week, Anaheim, Calif., Technical Contact:, (D15.22) Jonathan T. Light, Evans Cooling Systems Inc., Sharon, Conn., Phone: 860-435-2418; jtlight@comcast.net ; (D15.25) Edward Eaton Sr., Amalgatech, Phoenix, Ariz., Phone: 602-252-0280; edeaton@amalgatech.com ; (D15.30) John Panasewicz, Clear Choice Antifreeze, Henderson, Colo., Phone: 303-227-9900; johnp@clearchoiceantifreeze.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 #8837
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A series of proposed new standards being developed by ASTM International Committee D15 on Engine Coolants would remove technical barriers that currently prevent the cost-effective replacement of ethylene glycol with more environmentally friendly glycerin in antifreeze. The proposed standards are under the jurisdiction of Subcommittee D15.93 on Research and Long Range Planning. Natural glycerin is…
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Arc protective blankets are used in many electrical applications to protect workers who are stationed near energized electrical parts. While these blankets have been used for years, there have been no testing criteria for their evaluation. A new ASTM International standard will be used to determine the effectiveness of arc protective blankets in suppressing the combined effect of an arc flash and…
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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…