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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 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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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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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…
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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…