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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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ASTM International is developing a proposed standard that will help manufacturers of automatic guided industrial vehicles evaluate their products. In addition to manufacturers, vehicle buyers will use this standard (WK48955: Test Method for Docking and Navigation for Driverless Automatic Guided Industrial Vehicles) to conduct their own tests on potential purchases. ASTM member Roger Bostelman is…, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Roger V. Bostelman, National Institute of Standards and Technology, Gaithersburg, Md., tel +1.301.975.3426; roger.bostelman@nist.gov, ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #9811 ###
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A new ASTM International standard will provide accurate performance tests that are used to make sure that nuclear magnetic resonance spectrometers are running properly. ASTM E2977 , Practice for Measuring and Reporting Performance of Fourier-Transform Nuclear Magnetic Resonance (FT-NMR) Spectrometers for Liquid Samples, is the first ASTM standard that incorporates recent technological advances in…, Technical Contact:, Gary Kramer, Gaithersburg, Md., tel +1.301.990.9627; gary-kramer@comcast.net, ASTM Staff Contact:, Joe Koury, tel +1.610.832.9804; jkoury@astm.org, ASTM PR Contact:, Barbara Schindler, tel +1.610.832.9603; bschindl@astm.org Release #9756
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ASTM International has launched a new technical committee, F45 on Driverless Automatic Guided Industrial Vehicles . After organizational meetings in October 2013 and January 2014, F45 was approved at the board of director’s recent spring meeting. In use since 1953, automated guided vehicles (AGVs) are defined by the Material Handling Institute (MHI) as “computer-controlled wheel-based load…, Technical Contact:, Roger Bostelman, National Institute of Standards and Technology, Gaithersburg, Md., roger.bostelman@nist.gov , ASTM Staff Contact:, Pat Picariello, Phone: 610-832-9720; ppicariello@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9650
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Laboratory informatics tools are used in laboratory environments across the world that directly touch the everyday human experience. The rapid pace of change in the area of laboratory informatics over the last six years has led to a significant revision of ASTM E1578 , Guide for Laboratory Informatics. “Laboratory informatics tools are used in lab environments across many industries, including…, Technical Contact:, James B. Powers Jr., Bridge Associates LLC, Princeton, N.J., Phone: 610-659-2094; powers@balpharma.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 #9528
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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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ASTM International Committee E13 on Molecular Spectroscopy and Separation Science invites all interested parties to join in the ongoing revision of ASTM E1578 , Guide for Laboratory Information Management Systems (LIMS). ASTM E1578 is under the jurisdiction of Subcommittee E13.15 on Analytical Data . According to James B. Powers Jr., managing partner, Bridge Associates LLC, and chair of the E13.…