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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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Increasing interest in the various uses of electrical contacts is the leading impetus for the development of a proposed new standard, ASTM WK34423 , Specification for Electrodeposited Coatings of Palladium-Cobalt Alloy for Engineering Use. The proposed standard is being developed by Subcommittee B08.08 on Metallic Coatings , part of ASTM International Committee B08 on Metallic and Inorganic…, ASTM Committee B08 Next Meeting:, May 10, 2012, May Committee Week, Phoenix, Ariz., Technical Contact:, Sheikh H. Rahman, Lean Corp., Southfield, Mich., Phone: 248-447-1526; srahman@lear.com, ASTM Staff Contact:, Diane Trinsey, Phone: 610-832-9661; dtrinsey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9016
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A new ASTM subcommittee seeks to acknowledge the ongoing advances being made in the field of nanostructured inorganic coatings. B08.16 on Nanostructured Coatings, part of ASTM International Committee B08 on Metallic and Inorganic Coatings, is currently developing its first proposed standard, ASTM WK29468 , Specification for Galvanic Protection of Steel Using a Nanostructured Coating of 95 % Zinc…
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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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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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Plastic pipe and components are used with low pressure oxygen and enriched air for a variety of applications, including medical and healthcare, agriculture (fish farming), welding and fabrication, waste water treatment and others. Despite this widespread use, there are currently no standards that help in the materials selection and design features of these systems. ASTM International Committee…