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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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Rheologists are encouraged to join in the development of a proposed new practice that will help standardize calibration of rotational rheometers to obtain accurate normal force measurements. ASTM WK33687 , Practice for Normal Force Calibration for Rotational Rheometers, is being developed by Subcommittee E37.08 on Rheology , part of ASTM International Committee E37 on Thermal Measurements . The…, ASTM Committee E37 Next Meeting:, Aug. 10-11, in conjunction with the North American Thermal Analysis Society Annual Conference, Des Moines, Iowa, Technical Contact:, Kenneth Aniunioh, Shimadzu Scientific Instruments, Laurel, Md., Phone: 864-633-7690; kenebaano@yahoo.com, ASTM Staff Contact:, Thomas O’Toole, Phone: 610-832-9739; totoole@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8923
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The ASTM International Proficiency Testing Center is pleased to offer a 2010 Proficiency Testing Program on Thermal Analyses of Plastics (TAP) to laboratories who need a statistical quality assurance tool that will enable them to improve and maintain a high level of performance in conducting ASTM Differential Scanning Calorimetry (DSC), Oxidative-Induction Time (OIT) by Differential Scanning…, ASTM D3418, , Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC);, ASTM D3850, , Standard Test Method for Rapid Thermal Degradation of Solid Electrical Insulating Materials By Thermogravimetric Method (TGA); and, ASTM D3895, , Standard Test Method for Oxidative-Induction Time of Polyolefins by Differential Scanning Calorimetry. For each test trial, laboratory participants receive two sample materials along with interactive electronic data report forms and test instructions. Using the specified ASTM program tests, participating laboratories conduct the tests of their choice that they routinely run. Upon completion of…
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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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A need for a new test method to determine the effective thermal conductivity of fire resistive materials at high temperatures has prompted ASTM International Committee E37 on Thermal Measurements to begin work on a proposed new standard, WK12643 , Test Method for Slug Calorimetry. The proposed standard is under the jurisdiction of Subcommittee E37.05 on Thermophysical Properties. According to…
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ASTM International Committee E37 on Thermal Measurements is seeking participation in a new subcommittee, E37.09 on Biological Calorimetry. Since its inception, the focus of Committee E37 has been the creation of methods for the calibration and use of thermal analysis instrumentation. One of the first types of thermal analysis instruments that was developed commercially on a large scale was…
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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…