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A new ASTM International standard will provide accurate performance tests that are used to make sure that nuclear magnetic resonance spectrometers are running properly. ASTM E2977 , Practice for Measuring and Reporting Performance of Fourier-Transform Nuclear Magnetic Resonance (FT-NMR) Spectrometers for Liquid Samples, is the first ASTM standard that incorporates recent technological advances in…, Technical Contact:, Gary Kramer, Gaithersburg, Md., tel +1.301.990.9627; gary-kramer@comcast.net, ASTM Staff Contact:, Joe Koury, tel +1.610.832.9804; jkoury@astm.org, ASTM PR Contact:, Barbara Schindler, tel +1.610.832.9603; bschindl@astm.org Release #9756
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Laboratory informatics tools are used in laboratory environments across the world that directly touch the everyday human experience. The rapid pace of change in the area of laboratory informatics over the last six years has led to a significant revision of ASTM E1578 , Guide for Laboratory Informatics. “Laboratory informatics tools are used in lab environments across many industries, including…, Technical Contact:, James B. Powers Jr., Bridge Associates LLC, Princeton, N.J., Phone: 610-659-2094; powers@balpharma.com , ASTM Staff Contact:, Joe Koury, Phone: 610-832-9804; jkoury@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9528
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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 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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ASTM Committee E61 to Maintain and Develop International Standards, ASTM International, one of the largest voluntary standards development organizations in the world, has announced that ASTM Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications has been reorganized as ASTM Committee E61 on Radiation Processing . The new main committee will revise and maintain the existing Subcommittee E10.01 standards and will develop new standards that cover…, ASTM Committee E61 Next Meeting:, Jan. 27-29, 2013, Jacksonville, Fla., ASTM Staff Contact:, Joseph Koury, Phone: 610-832-9804; jkoury@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9231
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ASTM International Committee E13 on Molecular Spectroscopy and Separation Science invites all interested parties to join in the ongoing revision of ASTM E1578 , Guide for Laboratory Information Management Systems (LIMS). ASTM E1578 is under the jurisdiction of Subcommittee E13.15 on Analytical Data . According to James B. Powers Jr., managing partner, Bridge Associates LLC, and chair of the E13.…
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All interested parties, particularly end users from the forensics sciences, are encouraged to join in the development of a proposed new ASTM standard, WK18814 , Guide for Relative Intensity Correction of Raman Spectrometers. WK18814 is being developed by Subcommittee E13.08 on Raman Spectroscopy, which is under the jurisdiction of ASTM International Committee E13 on Molecular Spectroscopy and…
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Since the early 1980s, multivariate analytical techniques have been increasingly used in a variety of industries. A new ASTM International standard, E2617 , Practice for Validation of Empirically Derived Multivariate Calibrations, answers a need for standards for these techniques. Subcommittee E13.11 on Multivariate Analysis, under the jurisdiction of ASTM International Committee E13 on Molecular…
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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…