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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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A new ASTM International test method will help improve the measurements of uranium isotope ratios, helping laboratories analyze nuclear material and supporting efforts of organizations like the International Atomic Energy Agency (IAEA). The new standard is C1832 , Test Method for Determination of Uranium Isotopic Composition by the Modified Total Evaporation (MTE) Method Using a Thermal…, ASTM Committee C26 on Nuclear Fuel Cycle Next Meeting:, June 12-17, 2016, Vienna, Austria, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Stephan Richter, Institute for Reference Materials and Measurements; tel +32.14.571.701; stephan.richter@ec.europa.eu, ASTM Staff Contact:, Joe Koury, tel +1.610.832.9804; jkoury@astm.org Release #10002
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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 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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ASTM International Committee E11 on Quality and Statistics has approved the last in a series of ASTM standards that preserve military sampling standards that were originally under the jurisdiction of the U.S. Department of Defense. The new standard, ASTM E2910 , Guide for Preferred Methods for Acceptance of Product, preserves MIL-STD-1916 in its original form. ASTM E2910 is under the jurisdiction…, ASTM Committee E11 Next Meeting:, May 8-10, 2013, ASTM International Headquarters, West Conshohocken, Pa., Technical Contact:, Dean V. Neubauer, Corning, Inc., Corning, N.Y., Phone: 607-974-6777; neubauerdv@corning.com, ASTM Staff Contact:, Katerina Koperna, Phone: 610-832-9728; kkoperna@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9317
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ASTM International recently developed its, Roadmap in Support of Commercial Nuclear Power, to provide a practical set of plans for updating ASTM nuclear energy standards in conjunction with the Nuclear Energy Standards Coordination Collaborative (NESCC). The ultimate goal of the roadmap, a document that spells out these plans in detail, is to ensure a safe and economical source of electricity for now and in the future. A link to the Roadmap can be found in the ASTM Nuclear Portal at…, Technical Contact:, Stephen Byrne, Phone: 860-342-7363; pnsbyrne@yahoo.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 R elease #9321
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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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In many testing laboratories, it can be necessary to qualify a new test method, instrument or lab itself with respect to one or more performance characteristics. One such key characteristic is bias, or mutual agreement of average test results run on the same material. A proposed ASTM standard will aid in the determination of bias equivalency. ASTM WK37659 , Guide for Testing for Bias Equivalency…
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New ASTM Nuclear Fuel Cycle Standard Provides Guidelines for Gathering Physical and Rheological DataObtaining data from the measurement and calculation of physical and rheological properties of radioactive solutions, slurries and sludges is essential in developing appropriate simulants for the design and testing of retrieval, transport, mixing and storage systems for treating radioactive materials. A new ASTM International standard provides guidelines for gathering this data. ASTM C1752 , Guide…