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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 gasket manufacturers a test for measuring creep and compression that can be used for R&D and material comparisons, and as a quality assurance tool. ASTM F2837 , Test Method for Hot Compression Properties of Gasket Materials, was developed by Subcommittee F03.40 on Chemical Test Methods, under the jurisdiction of ASTM International Committee F03…, ASTM Committee F03 Next Meeting:, Oct 12-13, October Committee Week, San Antonio, Texas, Technical Contact:, James Lingenfelder, Gasket Resources Inc., Houston, Texas, Phone: 713-856-9445; jtling@durlon.com, ASTM Staff Contact:, Joseph Hugo, Phone: 610-832-9740; jhugo@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8695/Sept2010
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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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ASTM International Committee F03 on Gaskets has developed and approved a new standard that can be used to evaluate gasket materials covered by ASTM F104 , Classification System for Nonmetallic Gasket Materials. The new standard, F2716 , Practice for Comparison of Nonmetallic Flat Gaskets in High Pressure Saturated Steam, is under the jurisdiction of Subcommittee F03.10 on Composite Gaskets. ASTM…
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A new ASTM International standard responds to a recent emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments. The standard, ASTM E2614 , Guide for Evaluation of Cleanroom Disinfectants, was developed by Subcommittee E35.15 on Antimicrobial Agents, part of ASTM International Committee E35 on Pesticides 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…
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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…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has now approved its first practice. ASTM E 2474 , Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice. Practice E 2474 covers process design, which is integral to process…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has created a new subcommittee, E55.03 on General Pharmaceutical Standards, which will address issues on quality within a broad framework of chemistry, manufacturing and control. The scope of the new subcommittee is the development of general principles, practices and related standards for managing…