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As a result of the Safety Equipment Institute becoming a subsidiary of ASTM International on April 19, SEI is expanding its offerings beyond its existing product certifications to include personnel certifications and environmental declaration programs. The SEI Board Standing Committee on Certification Programs met for the first time yesterday. It approved operating manuals and procedures for SEI’…, Media Inquiries:, Dan Bergels, tel. +1.610.832.9602; dbergels@astm.org, SEI Staff Contact:, Pat Gleason, tel. +1.703.442.5732; pgleason@seinet.org Release #10101
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ASTM International, one of the world’s leading standards development organizations, announced today that it will serve as a top global venue for creating practices, guides and other standards for human resource (HR) management. The launch of Committee E63 on Human Resource Management follows a Dec. 14 organizational meeting held at ASTM headquarters in West Conshohocken, Pennsylvania. ASTM’s…, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #10011
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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 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…