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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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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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Since 2009, the National Fire Protection Association has required arc rated gloves in its NFPA70E, Standard for Electrical Safety in the Workplace. A new ASTM standard will now provide arc rating thermal protective values for gloves, which will allow more gloves to be used inside an arc flash zone when there is no shock hazard. The new standard, ASTM F2675/F2675M , Test Method for Determining Arc…, ASTM Committee F18 Next Meeting:, Oct. 20-23, 2013, Charleston, S.C., Technical Contact:, Hugh Hoagland, ArcWear, Louisville, Ky., Phone: 502-832-9737; hugh@arcwear.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 Release #9469
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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 standard being developed by ASTM International Committee F18 on Electrical Protective Equipment for Workers will provide guidance to assist in the required testing of live-line tools. ASTM WK33590 , Guide for In-Service Inspection, Maintenance and Electrical Testing of Insulating Tools (Fiberglass-Reinforced Plastic (FPR) and Wooden Live-Line Tools), is under the jurisdiction of…
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Arc protective blankets are used in many electrical applications to protect workers who are stationed near energized electrical parts. While these blankets have been used for years, there have been no testing criteria for their evaluation. A new ASTM International standard will be used to determine the effectiveness of arc protective blankets in suppressing the combined effect of an arc flash and…
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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…