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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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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 new ASTM International standard will provide safety and risk management professionals with an aid in measuring the slip resistance of footwear in a wide variety of flooring situations. ASTM F2913 , Test Method for Measuring the Coefficient of Friction for Evaluation of Slip Performance of Footwear and Test Surfaces/Flooring Using a Whole Shoe Tester, is under the jurisdiction of Subcommittee…
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Tribometers are used to assess the potential of humans to slip while walking on various surfaces. A new ASTM International test method will be used to provide a reference standard against which to validate and calibrate the performance of tribometers. ASTM F2508 , Practice for Validation and Calibration of Walkway Tribometers Using Reference Surfaces, has been developed by Subcommittee F13.10 on…
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ASTM International Committee F13 on Pedestrian/Walkway Safety and Footwear is currently working on a proposed new standard for footwear designed for workers who do not necessarily need safety toe shoes but could use other protection such as puncture resistance, electrical shock protection and electrical grounding. The proposed new standard, ASTM WK27855 , Specification for Performance…
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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…