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ASTM International Committee E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document a set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds. The proposed standard, ASTM WK39883 , Practice for Process of Inactivation of Enveloped…, ASTM Committee E55 Next Meeting:, April 9-11, 2013, Genzyme-A Sanofi Company, Haverhill, Suffolk, United Kingdom, Technical Contact:, John Schreffler, Ph.D., Morphotek Inc., Exton, Pa., Phone: 610-423-6557; jschreffler@morphotek.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9327
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A new ASTM International standard is focused exclusively on testing soil for asbestos. ASTM D7521 , Test Method for Determination of Asbestos in Soil, was developed by Subcommittee D22.07 on Sampling and Analysis of Asbestos , part of ASTM International Committee D22 on Air Quality . According to Alan Segrave, division manager, laboratory services, Bureau Veritas, and an ASTM D22 member, many…, ASTM Committee D22 Next Meeting:, April 14-17, April Committee Week, Indianapolis, Ind., Technical Contact:, Alan M. Segrave, Bureau Veritas North America Inc., Kennesaw, Ga., Phone: 770-590-6706; alan.segrave@us.bureauveritas.com, ASTM Staff Contact:, David Bradley, Phone: 610-832-9681; dbradley@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9295
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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 newly approved standard, ASTM D7338 , Guide for the Assessment of Fungal Growth in Buildings, has been developed to provide a go-to reference for anyone testing for mold in buildings. The new standard was developed by Subcommittee D22.08 on Sampling and Analysis of Mold, part of ASTM International Committee D22 on Air Quality. “The lack of consensus standards in the fungal sampling and analysis…, ASTM Committee D22 Next Meeting:, April 10-13, April Committee Week, Anaheim, Calif., Technical Contact:, Lisa Rogers, Mycometer, Inc., Tampa, Fla., Phone: 813-831-6511; lrogers@mycometer.com, ASTM Staff Contact:, David Bradley, Phone: 610-832-9681; dbradley@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8788
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Air permits from regulatory agencies, such as the U.S. Environmental Protection Agency (USEPA), often require the measurement of a plume's opacity as the plume is emitted from a stationary point source (for example, smokestacks) in the outdoor ambient environment. While such opacity is often visually measured by human observers as “certified smoke readers,” an opacity measurement method using…
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The measurement of acid mist is becoming increasingly important due to recent actions taken by the U.S. Environmental Protection Agency on fine particles (2.5 micrometers in diameter and smaller) that are unhealthy to breathe. ASTM International Committee D22 on Air Quality is currently working on a proposed standard for measuring acid mists that come from combustion sources, WK22846 , Test…
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A new ASTM International standard provides guidance for using data generated by ASTM standards in testing for asbestos in surface dust. ASTM D 7390 , Guide for Evaluating Asbestos in Dust on Surfaces by Comparison Between Two Environments, was approved by ASTM International Committee D22 on Air Quality, part of Subcommittee D22.07 on Sampling and Analysis of Asbestos. According to James Millette…
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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…