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ASTM F3131 , Specification for Epoxy/Cotton Raw Materials for Use in Bearing Cages, is a new ASTM standard that will benefit manufacturers of nearly any products that involve motion and bearings. ASTM member Drake DeFrane says that ASTM F3131 will be the first major standard to provide a guideline for engineering and design applications of epoxy/cotton raw materials used for making components…, ASTM Committee F34 Next Meeting:, Nov. 17-19, 2015, November committee week, Tampa, Fla., Technical Contact:, Drake DeFrane, Norplex-Micarta, Postville, Iowa, tel +1.563.864.4269; ddefrane@norplex-micarta.com, ASTM Staff Contact:, Joseph Hugo, tel +1.610.832.9740; jhugo@astm.org, ASTM PR Contact:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org Release #9766
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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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High-speed machine tool spindles and the high-pressure turbopumps that move liquid hydrogen in the space shuttle are just two examples of the uses for hybrid roller bearings. ASTM Subcommittee F34.01 on Rolling Element has now developed a standard for hybrid roller bearings, ASTM F2730/F2730M , Specification for Silicon Nitride Cylindrical Bearing Rollers. Subcommittee F34.01 is under the…
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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 new ASTM International standard that covers annular ball bearings intended primarily for use in instrument and precision rotating components has been developed as a conversion of a U.S. military standard, MIL-B-81793F, Annular Ball Bearings, for Instruments and Precision Rotating Components. The new standard, F 2332 , Specification for Annular Ball Bearings for Instruments and Precision…
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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…
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Joe Koury, staff manager for ASTM International Committee E52 on Forensic Psychophysiology, will speak at the annual seminar of the American Association of Police Polygraphists on April 17 at the Hotel Albuquerque at Old Town in Albuquerque, N.M. This meeting will follow the April 14-15 meetings of Committee E52, which will take place at the some hotel. In his presentation, Koury will provide an…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has now approved its first practice. ASTM E 2474 , Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice. Practice E 2474 covers process design, which is integral to process…