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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 proposed new ASTM International standard will provide the electrical power industry with a relatively straightforward test for oxidation stability of natural esters. Natural esters, also known as vegetable oils, can be used as an alternative to mineral oil as an insulating liquid in power transformers and other electrical equipment. The proposed standard is ASTM WK21616 , Test Method for…, ASTM Committee D27 Next Meeting:, Nov. 9-11, 2014, November Committee Week, New Orleans, La., Technical Contact:, Kevin J. Rapp, Cargill Industrial Specialties, Brookfield, Wis., Phone: 262-797-5584; kevin_rapp@cargill.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 #9618
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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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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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A proposed new ASTM International standard will provide an up-to-date method for the aluminum industry to analyze samples by inductively coupled plasma-atomic emission spectroscopy. The proposed new standard, WK35993 , Test Method for Analysis of Aluminum and Aluminum Alloys by Inductively Coupled Plasma Atomic Emission Spectrometry (Performance Based Method), is being developed by Subcommittee…
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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
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ASTM Committee E10 on Nuclear Technology and Applications has approved two new ASTM standards, ASTM E2628 , Practice for Dosimetry for Radiation Processing, and ASTM E2701 , Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing. Both standards are under the jurisdiction of Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications…, ASTM Committee E10 Next Meeting:, Jan. 24-27, January committee week, San Antonio, Texas, Technical Contact:, (E2628) John Logar, Ethicon Inc., Somerville, N.J., Phone: 908-218-5638; jlogar8@its.jnj.com ; (E2701) Rod Chu, Ottawa, Ontario, Canada, Phone: 613-565-2305; rodchu@rogers.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 #84 58/Jan2010
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ASTM International Committee D27 on Electrical Insulating Liquids and Gases is continuing its work on standards for natural esters with the development of a proposed new standard, WK21616 , Test Method for Oxidation Induction Time of Natural Ester Insulating Fluids by Pressure (PDSC) or Regular Differential Scanning Calorimetry (DSC). The proposed standard was submitted under the jurisdiction of…