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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 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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All interested parties are invited to participate in the standards developing activities of new Task Group D07.02.08 on structural insulated panels. The group is under the jurisdiction of Subcommittee D07.02 on Lumber and Engineered Wood Products , part of ASTM International Committee D07 on Wood . Structural insulated panels are a high performance building system for residential and light…, ASTM Committee D07 Next Meeting:, April 16-18, 2013, April Committee Week, Indianapolis, Ind., Technical Contact:, B.J. Yeh, P.E., APA – The Engineered Wood Association, Tacoma, Wash., Phone: 253-620-7467; borjen.yeh@apawood.org ; Eric Tompos, P.E., NTA, Nappanee, Ind., Phone: 574-773-7975; etompos@ntainc.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 R elease #9315
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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 D07 on Wood has approved a new standard, ASTM D7746 , Practice for Calculating the Superimposed Load on Wood-Frame Floor-Ceiling Assemblies for Standard Fire Resistance Tests. ASTM D7746, which was developed by Subcommittee D07.05 on Wood Assemblies , will be used in conjunction with other fire test standards. Standards such as ASTM E119, Test Methods for Fire Tests…
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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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A proposed revision to ASTM International standard ASTM D5456 , Specification for Evaluation of Structural Composite Lumber Products, would add bamboo as a fiber material that can be used in the manufacture of products covered in the standard. ASTM D5456 is under the jurisdiction of Subcommittee D07.02 on Lumber and Engineered Wood Products, part of ASTM International Committee D07 on Wood. 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…