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A new ASTM International standard will help medical device manufacturers collect sufficient data to demonstrate that they consistently clean medical devices to a safe and effective level. The new standard (soon to be published as F3127 , Guide for Validating Cleaning Lines for Medical Devices) is the result of a November 2011 symposium sponsored by ASTM on Cleaning Validation of Medical Devices.…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, May 3-5, 2016, May Committee Week, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Randall J. Thoma, Ph.D., VeeSquared Consulting Services, Round Rock, Texas, tel +1.512.924.3832; randy.thoma@VeeSquared.com, ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #10050
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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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A series of proposed new ASTM International standards will help instrument manufacturers create modern and safe flight instruments designed for light sport aircraft and other similarly equipped and sized aircraft. The proposed standards are being developed by Subcommittee F39.03 on Design of Avionics Systems , part of ASTM International Committee F39 on Aircraft Systems . “The creation of…, Technical Contact:, Andrew Barker, TruTrak Flight Systems, Springdale, Ark., Phone: 479-751-0250; andrew@trutrakap.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 #9624
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The use of infrared technology is gaining popularity in the forensic engineering and building science fields. One such use is identifying specific locations of water damage to buildings without requiring complete removal or deconstruction of building systems or facades. A proposed new ASTM International standard will provide guidelines for this usage. ASTM WK44618 , Guide for the Use of Infrared…, Technical Contact:, Robin Girard, Bracken Engineering, Tampa, Fla., Phone: 813-243-4251; rgirard@brackenengineering.com , ASTM Staff Contact:, Kelly Paul, Phone: 610-832-9745; kpaul@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9595
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Incidents involving electrical systems can result in injuries and fatalities that need to be safely and efficiently investigated and a proposed new ASTM guide will provide a basis for such investigations. ASTM WK41392 , Guide for Investigating Electrical Incidents, is being developed by Subcommittee E58.04 on Electrical Incidents , part of ASTM International Committee E58 on Forensic Engineering…, ASTM Committee E58 Next Meeting:, January 2014, in conjunction with National Academy of Forensic Engineers January meeting, Charlotte, S.C. (date to be determined), Technical Contact:, Johannes Laun, Professional Analysis and Consulting Inc., Sugar Grove, Ill., Phone: 630-466-4040; jclaun@proaacl.com, ASTM Staff Contact:, Kelly Paul, Phone: 610-832-9745; kpaul@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9433
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, ASTM to Partner with ASC to Foster EPD Development, ASTM International will be collaborating with industry to develop Environmental Product Declarations (EPDs) across the 90+ industry markets they support, including sealants. The Adhesive and Sealant Council (ASC) will be partnering with ASTM International to raise awareness of this effort, educate industry on the value of Type III EPDs, and proactively engage industry in developing Product…, ASTM Staff Contact:, Tim Brooke, Phone: 610-832-9729; tbrooke@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9370
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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 join in the standards developing activities of new Subcommittee E58.06 on Incidents Involving Structures , part of ASTM International Committee E58 on Forensic Engineering . Forensic engineering is defined by the National Academy of Forensic Engineers as “the application of the art and science of engineering in matters which are in, or may possibly relate to…, ASTM Committee E58 Next Meeting:, Jan. 18, 2013, in conjunction with the National Society of Forensic Engineers, Newport Beach, Calif., Technical Contact:, Robin Girard, Bracken Engineering, Tampa, Fla., Phone: 813-243-4251; rgirard@brackenengineering.com, ASTM Staff Contact:, Kelly Paul, Phone: 610-832-9745; kpaul@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindler@astm.org R elease #9244
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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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Sealant manufacturers will use a new ASTM International standard to evaluate new products and changes to these products due to exposure to weather. The new standard, ASTM C1735 , Test Method for Measuring the Time Dependent Modulus of Sealants Using Stress Relaxation, is under the jurisdiction of Subcommittee C24.20 on General Test Methods , part of ASTM International Committee C24 on Building…, ASTM Committee C24 Next Meeting:, Jan. 8-10, 2012, Ft. Lauderdale, Fla., Technical Contact:, Christopher C. White, Ph.D., National Institute of Standards and Technology, Gaithersburg, Md., Phone: 301-975-6016; christopher.white@nist.gov, ASTM Staff Contact:, Stephen Mawn, Phone: 610-832-9726; smawn@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9005