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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 standard covers the principal dimensions and materials of closed chocks, used for mooring, for installation on ships. The new standard, ASTM F2935 , Specification for Chocks, Ship Mooring, Cast Steel, has been developed by Subcommittee F25.01 on Structures , part of ASTM International Committee F25 on Ships and Marine Technology . Chocks are mounted directly on the deck,…
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Fiber reinforced plastic gratings are often used as walkways for a variety of marine vessels. A proposed new ASTM International standard will cover several aspects of fiber reinforced plastic gratings, including fire testing procedures, ultraviolet effects and moisture absorption. The proposed standard, ASTM WK31924 , Specification for Fiber Reinforced Plastic (FRP) Gratings Used in Marine…, ASTM Committee F25 Next Meeting:, May 17-19, 2011 May Committee Week, Anaheim, Calif., Technical Contact:, John H. Miller, U.S. Coast Guard, Washington, D.C., Phone: 201-372-1372; john.h.miller@uscg.mil, ASTM Staff Contact:, Robert Morgan, Phone: 610-832-9732; rmorgan@astm.org R elease #8816
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A new ASTM International standard will be used to prevent fire and explosions on the decks of tank vessels used to transport hazardous products. ASTM F2876 , Practice for Thermal Rating and Installation of Internal Combustion Engine Packages for Use in Hazardous Locations in Marine Applications, was developed by Subcommittee F25.07 on General Requirements, part of ASTM International Committee F25…, ASTM Committee F25 Next Meeting:, May 17-19, 2011, May Committee Week, Anaheim, Calif., Technical Contact:, James Lawrence, U.S. Coast Guard, Washington, D.C., Phone: 202-372-1382; james.d.lawrence@uscg.mil, ASTM Staff Contact:, Robert Morgan, Phone: 610-832-9732; rmorgan@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8787
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Many ship owners and operators repair ship structures with temporary steel patches known as doublers. The U.S. Coast Guard and Navy, as well as other maritime authorities, usually allow such patches until the ship’s next inspection period, which can be as long as three to five years from the date of repair. Despite this situation, there is not currently a standard for repairing steel hull ships…, ASTM Committee F25 Next Meeting:, May 17-19, 2011, May Committee Week, Anaheim, Calif., Technical Contact:, Chao H. Lin, Maritime Administration, U.S. Department of Transportation, Washington, D.C., Phone: 202-366-1847; chao.lin@dot.gov, ASTM Staff Contact:, Robert Morgan, Phone: 610-832-9732; rmorgan@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8750
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All interested parties are invited to participate in the development of a new standard, ASTM WK28289 , Guide for Design, Operation, Inspection and Maintenance of Oil Spill Response Vessels (OSRV). The proposed standard is being developed by Subcommittee F25.07 on General Requirements, part of ASTM International Committee F25 on Ships and Marine Technology. According to Thane Gilman, systems…
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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…