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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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Current members of ASTM International Committees C01 on Cement and C09 on Concrete and Concrete Aggregates , and other interested parties, are invited to join a new C01 subcommittee, C01.98 on Sustainability Assessment. The scope of C01.98 is to support the development and maintenance of standards related to methodologies and metrics for assessing sustainability in the manufacture and use of…
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A new ASTM International practice provides a standard for preparing a mixture of cement paste that will simulate the shearing experienced by the cement paste in concrete. The new standard, ASTM C1738 , Practice for High-Shear Mixing of Hydraulic Cement Pastes, was developed by Subcommittee C01.22 on Workability , part of ASTM International Committee C01 on Cement . According to Chiara Ferraris,…
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Rapid hardening hydraulic cements are used in a variety of applications in which reduced cementitious contents are desired or early service is needed. Included among these applications are paving, construction, stucco, mortar and block. A newly approved ASTM International standard covering these cements, ASTM C1600/C1600M , Specification for Rapid Hardening Hydraulic Cement, has been developed by…, Type URH, —ultra rapid hardening, for use where ultra high early strength is desired;, Type VRH, —very rapid hardening, for use where very high early strength is desired;, Type MRH, —medium rapid hardening, for use where mid-range rapid hardening, high early strength is desired; and, Type GRH, —general rapid hardening, for use when the higher strength properties of Type VRH or a Type MRH cement is not required. “ASTM C1600 lists minimum requirements for compressive strength, setting time, shrinkage and soundness (autoclave expansion),” says Hicks. “Optional specifications for sulfate expansion, alkali silicate reactions with aggregates, heat of hydration and expansion in water are also…
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ASTM International has published a new American National Standard, ASTM E2659 , Standard Practice for Certificate Programs. This standard provides much-needed guidance to certificate issuers on how to develop a quality certificate program and to consumers on how to identify such a program. In addition, the standard is designed to serve as the benchmark of quality for industry accreditation of…
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All interested parties are invited to attend the first meeting of ASTM International Subcommittee E36.30 on Personnel Certificate Programs on June 23 at the Hyatt Regency Convention Center in Denver, Colo. The new subcommittee is part of ASTM International Committee E36 on Laboratory and Inspection Agency Accreditation, which will be meeting in Denver June 23-24. ASTM Subcommittee E36.30 will…
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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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A recently approved revision to ASTM International standard C 150 , Specification for Portland Cement, includes three significant technical changes to the document. The changes are part of a joint effort between ASTM and the American Association of State and Highway and Transportation Officials to harmonize C 150 with AASHTO’s standard, M 85, Specification for Portland Cement. C 150 is under the…