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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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Producers that perform verification testing of thermocouples and thermocouple components, along with those who write thermocouple product specifications, will be the primary users of a newly approved standard, ASTM E2820 , Test Method for Evaluating Thermal EMF Properties of Base-Metal Thermocouple Connectors. The new standard is under the jurisdiction of Subcommittee E20.04 on Thermocouples ,…
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Discussions concerning how easily test results for dimension stone test specimens can be influenced by improper or nonuniform preparation methods have led to the ongoing development of a proposed new ASTM International standard. The new standard, ASTM WK31179 , Practice for Selection and Preparation of Dimension Stone Test Specimens, is being developed by Subcommittee C18.08 on Selection of…
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Petrography is routinely performed on dimension stone for many construction projects in which new stone is being used, and it is often required in technical specifications. In order to facilitate this process, ASTM International Committee C18 on Dimension Stone has developed a new standard, ASTM C1721 , Guide for Petrographic Examination of Dimension Stone. The new standard is under the…, ASTM Committee C18 Next Meeting:, April 21-22, April Committee Week, St. Louis, Mo., Technical Contact:, Michael Scheffler, Wiss, Janney, Elstner Associates Inc., Northbrook, Ill., Phone: 847-272-7400; mscheffler@wje.com, ASTM Staff Contact:, Jeff Adkins, Phone: 610-832-9738; jadkins@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8432/Dec2009
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Providing practical advice on the use of infrared thermometers is the purpose of a proposed new ASTM International standard. Infrared thermometry is used in a variety of measurement applications, including heating, ventilating and air conditioning, building inspection, industrial and manufacturing, automotive and food service equipment. The proposed new standard, ASTM WK21204 , Guide for the…
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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…