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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…
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ASTM International Committee A05 on Metallic-Coated Iron and Steel Products will host a workshop, Hazardous Substances Affecting Metallic-Coated Steel and Other Metals, on May 23, 2007, during ASTM Committee Week in Norfolk, Va. The workshop will begin at 8:00 a.m. The topic will be the European Parliament and Council Directive on the Restrictions and use of certain Hazardous Substances in…
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When ASTM International Committee F38 on Unmanned Aircraft Systems was formed in 2003, it is safe to say no one on the committee was thinking about catapults and trebuchets. However, a study of these medieval devices was integral to the development of a new F38 standard, F 2585 , Specification for Design and Performance of Pneumatic-Hydraulic Unmanned Aircraft System (UAS) Launch System. F 2585…
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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…
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All interested parties are invited to attend the meetings of ASTM International Committee F38 on Unmanned Aircraft Systems on Nov. 13 and 14, during the November Committee Week in Atlanta, Georgia. The subjects to be discussed at the meeting are sense-and-avoid, terminology, launchers, visual range flight practices, commercial pilot practices and manufacturing quality assurance practice. One trio…
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Having the necessary documentation to maintain and repair any sort of aircraft is of the utmost importance. With this in mind, ASTM International Committee F38 on Unmanned Aircraft Systems has developed a new standard, F 2584 , Practice for Maintenance and Development of Maintenance Manuals for Light Unmanned Aircraft System (UAS). The new practice, which is under the jurisdiction of Subcommittee…
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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has created a new subcommittee, E55.03 on General Pharmaceutical Standards, which will address issues on quality within a broad framework of chemistry, manufacturing and control. The scope of the new subcommittee is the development of general principles, practices and related standards for managing…
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The U.S. Department of Defense recently adopted a commercial standard to govern the performance of automated sense and avoid systems it procures for its unmanned aircraft. The standard, ASTM F 2411, Specification for Design and Performance of an Airborne Sense-and-Avoid System, was developed last year by ASTM Internationals F38 Committee on Unmanned Aircraft Systems, whose members represent a…