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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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Halon 1211 is employed in hand-held fire extinguishers on civilian aircraft. A new ASTM International standard will be used to test Halon 1211 to ensure that the product will provide the required level of fire protection and is free of harmful impurities that could affect its safety in use. ASTM D7673 , Specification for Halon 1211, Bromochlorodifluoromethane (CF2BrCl), was developed by…, ASTM Committee D26 Next Meeting:, June 15, 2011, June Committee Week, Anaheim, Calif., Technical Contact:, Mark L. Robin, DuPont Fluoroproducts, Wilmington, Del., Phone: 302-999-5002; mark.l.robin@usa.dupont.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 #8791
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Wet blue and wet white are intermediate products used by tanneries that process natural hides and skins into leather. Natural fats and oils need to be largely removed from wet blue and wet white for leather processing to be done properly, but no standard had previously existed to evaluate the effectiveness of such removal. ASTM International Committee D31 on Leather has now developed such a…
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Producers of fluorocarbons are invited to join in the ongoing standards developing activities of ASTM International Committee D26 on Halogenated Organic Solvents and Fire Extinguishing Agents. The committee has recently approved a new standard, ASTM D7509 , Specification for Fluorocarbon Feedstock Grade Chloroform, under the jurisdiction of Subcommittee D26.08 on Halogenated Organics Used as…
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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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Finding ways to assure the quality and safe handling of fire extinguishing agents has led to the development of two new ASTM International standards, D 7323 , Practice for Handling, Transportation and Storage of IG-100 (Nitrogen), and D 7325 , Practice for Handling, Transportation and Storage of IG-541, N2, Ar, CO2. The new standards were developed by Subcommittee D26.09 on Fire Extinguishing…
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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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Providing users with an assurance of quality and ensuring the safe handling, transport and storage of fire extinguishing agents are the purposes of a new ASTM International standard, D 7327 , Specification for HFC Blend B (CH2FCF3, CHF2CF3 and CO2). The new standard was developed by Subcommittee D26.09 on Fire Extinguishing Agents, which is part of ASTM International Committee D26 on Halogenated…
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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…