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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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Users of standards involving kinetic parameters need reference materials to qualify individual laboratories and to validate procedures and software. A new ASTM International standard will provide such parameters to accommodate apparatus configurations and kinetic models. ASTM E2781 , Practice for Evaluation of Methods for Determination of Kinetic Parameters by Thermal Analysis, was developed by…, ASTM Committee E27 Next Meeting:, Nov. 15-17, November Committee Week, Tampa, Fla., Technical Contact:, Roger Blaine, Corvallis, Ore., Phone:, 302-559-6827; roger.l.blaine@gmail.com ASTM Staff Contact:, Scott Orthey, Phone: 610-832-9730; sorthey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8893
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Proposed ASTM Kinetic Parameters Standard Being Developed by Hazard Potential of Chemicals CommitteeA proposed new standard being developed by ASTM International Committee E27 on Hazard Potential of Chemicals will provide needed reference materials for instruments, applications and software used for the evaluation of kinetic data used for hazard evaluation. The proposed new standard, ASTM WK27880 , Practice for Evaluation of Methods for Determination of Kinetic Parameters by Thermal Analysis,…, ASTM Committee E27 Next Meeting:, Nov. 15-17, November Committee Week, Tampa, Fla., Technical Contact:, Roger Blaine, Corvallis, Ore., Phone: 302-559-6827; roger.l.blaine@gmail.com, ASTM Staff Contact:, Scott Orthey, Phone: 610-832-9730; sorthey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8611
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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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Joe Koury, staff manager for ASTM International Committee E52 on Forensic Psychophysiology, will speak at the annual seminar of the American Association of Police Polygraphists on April 17 at the Hotel Albuquerque at Old Town in Albuquerque, N.M. This meeting will follow the April 14-15 meetings of Committee E52, which will take place at the some hotel. In his presentation, Koury will provide an…
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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…
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A process hazard analysis prior to the startup of a chemical processing facility is essential to prevent catastrophic incidents due to thermal runaway reactions. A proposed new ASTM standard, WK9584, Guide for Assessing Potential Hazards of Synthesis Reactions Using Reaction Calorimetry, will help to standardize how the results from reaction calorimetry experiments are used in a process hazard…