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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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While the quality of coating materials for buried pipe at nuclear power plants has evolved over time, there is currently no written standard that would allow plants to fully take advantage of advances in coating technology. A proposed new standard will provide coating guidance for plants seeking to repair or replace buried pipe. The proposed standard, ASTM WK36282 , Guide for Selection of Coating…
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Sealant manufacturers will use a new ASTM International standard to evaluate new products and changes to these products due to exposure to weather. The new standard, ASTM C1735 , Test Method for Measuring the Time Dependent Modulus of Sealants Using Stress Relaxation, is under the jurisdiction of Subcommittee C24.20 on General Test Methods , part of ASTM International Committee C24 on Building…, ASTM Committee C24 Next Meeting:, Jan. 8-10, 2012, Ft. Lauderdale, Fla., Technical Contact:, Christopher C. White, Ph.D., National Institute of Standards and Technology, Gaithersburg, Md., Phone: 301-975-6016; christopher.white@nist.gov, ASTM Staff Contact:, Stephen Mawn, Phone: 610-832-9726; smawn@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9005
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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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The use of rolling devices can provide a means to evaluate the adhesion of weather seals, for quality control in new installations, general evaluation of existing installations, and the investigation of water and air leakage through building enclosures. In order to better facilitate the use of rolling devices, ASTM International Committee C24 on Building Seals and Sealants is developing a…
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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…