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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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Keeping birds away from potentially fatal encounters with building exteriors is the purpose of a proposed new ASTM International standard, ASTM WK47853 , Test Method for Bird Collision Deterrence Material Threat Factor. It is possible that as many as a billion birds are killed every year after colliding with glass on buildings, including many single-family homes — and this is in the United States…, ASTM Committee C14 Next Meeting:, April 14, 2015, Moorestown, N.J., Technical Contact:, Stefan Knust, Ennead Architects, New York, New York, tel +1.212.807.7171; sknust@ennead.com, ASTM Staff Contact:, Thomas O’Toole, tel +1.610.832.9739; totoole@astm.org, ASTM PR Contact:, Barbara Schindler, tel +1.610.832.9603; bschindl@astm.org Release #9767
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The use of infrared technology is gaining popularity in the forensic engineering and building science fields. One such use is identifying specific locations of water damage to buildings without requiring complete removal or deconstruction of building systems or facades. A proposed new ASTM International standard will provide guidelines for this usage. ASTM WK44618 , Guide for the Use of Infrared…, Technical Contact:, Robin Girard, Bracken Engineering, Tampa, Fla., Phone: 813-243-4251; rgirard@brackenengineering.com , ASTM Staff Contact:, Kelly Paul, Phone: 610-832-9745; kpaul@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9595
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Incidents involving electrical systems can result in injuries and fatalities that need to be safely and efficiently investigated and a proposed new ASTM guide will provide a basis for such investigations. ASTM WK41392 , Guide for Investigating Electrical Incidents, is being developed by Subcommittee E58.04 on Electrical Incidents , part of ASTM International Committee E58 on Forensic Engineering…, ASTM Committee E58 Next Meeting:, January 2014, in conjunction with National Academy of Forensic Engineers January meeting, Charlotte, S.C. (date to be determined), Technical Contact:, Johannes Laun, Professional Analysis and Consulting Inc., Sugar Grove, Ill., Phone: 630-466-4040; jclaun@proaacl.com, ASTM Staff Contact:, Kelly Paul, Phone: 610-832-9745; kpaul@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9433
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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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All interested parties are invited to join in the standards developing activities of new Subcommittee E58.06 on Incidents Involving Structures , part of ASTM International Committee E58 on Forensic Engineering . Forensic engineering is defined by the National Academy of Forensic Engineers as “the application of the art and science of engineering in matters which are in, or may possibly relate to…, ASTM Committee E58 Next Meeting:, Jan. 18, 2013, in conjunction with the National Society of Forensic Engineers, Newport Beach, Calif., Technical Contact:, Robin Girard, Bracken Engineering, Tampa, Fla., Phone: 813-243-4251; rgirard@brackenengineering.com, ASTM Staff Contact:, Kelly Paul, Phone: 610-832-9745; kpaul@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindler@astm.org R elease #9244
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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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New ASTM Committee E58 to Develop Standards That Support Engineering Investigations and Assist the Court, ASTM International, one of the largest voluntary standards development organizations (SDO) in the world, today announced the formation of ASTM Committee E58 on Forensic Engineering . Committee E58 will develop standards that promote awareness of the scientific, engineering, ethical and legal considerations inherent in forensic engineering investigations, reporting and testimony., Bringing Engineering Reason to the Dispute Resolution Process, Forensic engineering focuses on the investigation of alleged defects in materials, products, structures and components. These cases are litigated on the premise that the defects cause personal injury or damage to property. Forensic engineering investigations may help determine the causes of these events and assist the disputing parties or the court in resolving the case. Today, forensic…, Assisting the Court through Consensus Standards, ASTM Committee E58 comes together to create important standards and guides that will support the judicial process by facilitating an improved understanding of forensic engineering practices and associated technical issues. This will better enable the court to resolve disputes in a more well-informed and efficient manner, relying on deeper knowledge of the technical data presented and the sound…, E58 Standards: Guiding Forensic Engineering Practice, E58 standards will help guide forensic engineers in conducting investigations in a robust manner while protecting overall public safety. The initial scope of Committee E58 activities will be driven by subcommittees on Product Defect Incidents, Vehicular Incidents, Electrical Incidents and Industrial Processes. ASTM Committee E58 will build upon the body of work of former subcommittee E30.05 on…, Foundation Standard for the Forensic Engineering Profession, Other E58 standards will bolster the role of forensic engineering professionals in the eyes of the court and other users of these services. Consistent with this objective, Committee E58 has recently drafted a general practice document for the forensic engineering profession, titled Standard Guide for the Practice of Forensic Engineering. The goal of this standard is to further educate the court…
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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…