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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 F3131 , Specification for Epoxy/Cotton Raw Materials for Use in Bearing Cages, is a new ASTM standard that will benefit manufacturers of nearly any products that involve motion and bearings. ASTM member Drake DeFrane says that ASTM F3131 will be the first major standard to provide a guideline for engineering and design applications of epoxy/cotton raw materials used for making components…, ASTM Committee F34 Next Meeting:, Nov. 17-19, 2015, November committee week, Tampa, Fla., Technical Contact:, Drake DeFrane, Norplex-Micarta, Postville, Iowa, tel +1.563.864.4269; ddefrane@norplex-micarta.com, ASTM Staff Contact:, Joseph Hugo, tel +1.610.832.9740; jhugo@astm.org, ASTM PR Contact:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org Release #9766
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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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ASTM Committee C07 on Lime celebrates 100 years of standards development this year, and its June 27-28 meetings in San Diego, Calif., will feature special events to commemorate this milestone in addition to its regular technical meetings. The committee includes more than 70 professionals who represent lime producers, testing labs, building contractors, utility companies, equipment vendors and…
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A type of lime that has been used in construction since ancient Roman times is now covered by an ASTM International standard. ASTM International Committee C07 on Lime has approved ASTM C1707 , Specification for Pozzolanic Hydraulic Lime for Structural Purposes. The new standard is under the jurisdiction of Subcommittee C07.02 on Specifications and Guidelines. According to Margaret Thomson, the…
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High-speed machine tool spindles and the high-pressure turbopumps that move liquid hydrogen in the space shuttle are just two examples of the uses for hybrid roller bearings. ASTM Subcommittee F34.01 on Rolling Element has now developed a standard for hybrid roller bearings, ASTM F2730/F2730M , Specification for Silicon Nitride Cylindrical Bearing Rollers. Subcommittee F34.01 is under the…
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A proposed new ASTM International standard will provide a method for a comparative evaluation of limestone sources available for use in flue gas desulfurization (FGD) applications. The proposed standard, WK20129 , Test Method for Evaluating Limestone for Use in Wet Flue Gas Desulfurization Applications by Reactivity, is being developed by Subcommittee C07.05 on Chemical Tests, part of ASTM…
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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…