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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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A new ASTM International test method will provide an effective screening method to identify magnets that are subject to excessive corrosion in high humidity environments. ASTM A1071/A1071M , Test Method for Evaluating Hygrothermal Corrosion Resistance of Permanent Magnet Alloys, was developed by Subcommittee A06.01 on Test Methods , part of ASTM International Committee A06 on Magnetic Properties…
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ASTM International Committee A06 on Magnetic Properties welcomes the participation of all stakeholders with an interest in the development of international standards for magnetic materials and magnetic properties. The committee will hold its biannual meeting this fall. ASTM Committee A06, which was formed in 1903, oversees approximately 50 standards dealing with magnetic materials and magnetic…, ASTM Staff Contact:, Kelly Paul, Phone: 610-832-9745; kpaul@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8975
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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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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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ASTM International Committee A06 on Magnetic Properties has approved the first in a series of proposed standards on permanent magnet materials. The new standard, A 1054 , Specification for Sintered Ceramic Ferrite Permanent Magnets, as well as the other proposed standards, are under the jurisdiction of Subcommittee A06.02 on Material Specifications. While ASTM has long had standards covering…
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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…