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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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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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A newly approved ASTM International standard will advance the cause of architectural preservation. The new standard, ASTM C1713 , Specification for Mortars for the Repair of Historic Masonry, was developed by Subcommittee C12.03 on Specifications for Mortars, part of ASTM International Committee C12 on Mortars and Grouts for Masonry Units. John Wathne, structural engineer and president of…
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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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In response to changing emissions restrictions and consumer expectations, ASTM International Committee D15 on Engine Coolants is now developing a proposed new standard, WK16003 , Specification for Engine Coolant Grade 1,3-propanediol (PDO). This task group is under the jurisdiction of Subcommittee D15.07 on Specifications. Edward Eaton, D15 member and chief engineer, Amalgatech, says that as…
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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…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has now approved its first practice. ASTM E 2474 , Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice. Practice E 2474 covers process design, which is integral to process…