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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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Three-dimensional laser scanning is a maturing technology that holds great promise for capturing highly accurate information about an object or scene by collecting millions of dense measurements very quickly. ASTM International Committee E57 on 3D Imaging Systems is developing new standards for this technology, including ASTM E2807 , Specification for 3D Imaging Data Exchange, Version 1.0. ASTM…
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A new task group within ASTM Committee E57 on 3D Imaging Systems plans to develop standards on position and orientation (pose) determination that could help increase productivity and enhance the global competitiveness of the U.S. manufacturing industry. The task group, under the jurisdiction of Subcommittee E57.02 on Test Methods, is currently working on its first proposed new standard, ASTM…
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Three-dimensional laser scanning is an emerging technology that holds great promise for capturing dimensionally accurate information about an object or scene by collecting millions of dense measurements very quickly. ASTM International Committee E57 on 3D Imaging Systems is developing new standards for this technology, including ASTM E2761, Specification for 3D Imaging Data Exchange. ASTM E2761,…
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Three dimensional image system technology is now used in a wide variety of industries, including construction, mapping, manufacturing, mining and forensics. For all of these industries, safe usage of 3D imaging equipment is a top priority. However, until the approval of a new ASTM International standard, no safety guidelines specifically oriented toward 3D image system technology existed. The…
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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…
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The ASTM International committee formerly known as E55 on Pharmaceutical Application of Process Analytical Technology has undergone a change in title and scope that reflects the intent of the committee to be more inclusive of all the tools, instrumentation and sciences that might be used by the industry in the management of pharmaceutical manufacturing processes. The committee is now known as E55…